The Medicines (Products for Human Use) (Fees) Regulations 2010 (revoked)

Regulations 12(1)(a), 16,18(1), 19(1), 22(1), 26(1)

SCHEDULE 1 CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, MARKETING AUTHORIZATIONS, LICENCES, AUTHORISATIONS, REGISTRATIONS AND CERTIFICATES

PART 1 General: interpretation and categories of applications and variations

Interpretation

1.  In this Schedule—

“active ingredient” means an ingredient of a medicinal product in respect of which efficacy is claimed (whether therapeutic, diagnostic or otherwise);

“active ingredient from a new source” means an active ingredient in respect of which the application names as manufacturer a manufacturer not previously named as the manufacturer of that active ingredient included in a medicinal product in respect of which a marketing authorization (other than a product licence of right) or a traditional herbal registration has previously been granted;

“certificate of registration” means a certificate for the purposes of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994;

“EU marketing authorization” means—

(a)

a marketing authorization; or

(b)

an authorization issued by a competent authority of an EEA State other than the United Kingdom for the purposes of Article 6 of the 2001 Directive;

“the MHRA portal” means the internet-based hosted platform which enables persons to carry out business with the Medicines and Healthcare products Regulatory Agency of the Department of Health electronically, known as the “the MHRA Portal”;

“new active ingredient” means an active ingredient that has not previously been included as an active ingredient in a medicinal product in respect of which a marketing authorization (other than a product licence of right) has previously been granted;

“new excipient” means—

(a)

except in Part 2, paragraph 33 and Part 4, any ingredient of a medicinal product, other than an active ingredient, that has not previously been included in a medicinal product—

(i)

which is intended to be administered by the same route of administration as the product in question; and

(ii)

in respect of which a marketing authorization (other than a product licence of right), a certificate of registration or a traditional herbal registration has previously been granted,

except that in the case of a medicinal product intended to be administered orally, the expression does not include any ingredient specified in any enactment (including an enactment comprised in subordinate legislation or in any Directive, Regulation or Decision of the European Union) as an approved ingredient or additive in food or in a food product;

(b)

in Part 2, paragraph 33 and Part 4, any ingredient of a medicinal product, other than an active ingredient, that has not previously been included in a medicinal product which is intended to be administered by the same route of administration as the product in question and in respect of which a marketing authorization (other than a product licence of right), a certificate of registration or a traditional herbal registration has previously been granted, except that—

(i)

in the case of a medicinal product intended to be administered orally, the expression does not include any ingredient specified in any enactment (including an enactment comprised in subordinate legislation or in any Directive, Regulation or Decision of the European Union) as an approved ingredient or additive in food or in a food product; and

(ii)

in the case of a medicinal product intended for external use only, the expression does not include any ingredient specified in any enactment (including an enactment comprised in subordinate legislation or in any Directive, Regulation or Decision of the European Union) as an approved ingredient or additive in a cosmetic product;

“Phase I trial” means a clinical trial to study the pharmacology of a medicinal product when administered to humans, where the sponsor and investigator have no knowledge of any evidence that the product has effects likely to be beneficial to the subjects of the trial;

“Phase II or Phase III trial” means a clinical trial, other than a Phase I trial, where the medicinal product being tested—

(a)

does not have an EU marketing authorization; or

(b)

has an EU marketing authorization, but—

(i)

there has been a change—

(aa)

to the process of manufacture of the product or its active ingredient; or

(bb)

of manufacturer of that product, or

(ii)

the product is to be used in the trial other than in accordance with the terms of the summary of product characteristics under that authorization;

“Phase IV trial” means a clinical trial other than a Phase I trial or a Phase II or Phase III trial;

“TSE risk ingredient from a new source” and “TSE risk excipient from a new source” mean an active ingredient or excipient, respectively, which has been manufactured from raw materials of ruminant origin or which has had raw materials of ruminant origin used in its manufacture and in respect of which—

(a)

the application names as manufacturer, a manufacturer not previously named as the manufacturer of that ingredient or excipient included in a medicinal product in respect of which a marketing authorization (other than a product licence of right), a certificate of registration or a traditional herbal registration has previously been granted; and

(b)

no European Pharmacopoeia certificate of suitability covering the excipient has been submitted with the application;

“vitamin or mineral from a new source” means a vitamin or mineral in respect of which the application names as manufacturer a manufacturer not previously named as the manufacturer of that vitamin or mineral included in a medicinal product in respect of which a marketing authorization (other than a product licence of right) or a traditional herbal registration has previously been granted.

General: categories of Applications and Variations

2.—(1) In this Schedule, references to a particular type of application, variation or variation application shall be construed in accordance with this paragraph and paragraphs 3 to 23.

(2) A reference to—

“eCTD format” means the electronic format of the Common Technical Document referred to in the guidance published by the European Commission in Volume 2B of “The Rules Governing Medicinal Products in the European Union”, referred to in paragraph (1) of the Introduction to Annex I to the 2001 Directive;

“eCTD format application” means an application made using the MHRA portal and in relation to which the accompanying particulars and documents are presented in eCTD format; and

“European reference product application” means an application for a marketing authorization to which the third sub-paragraph of Article 10(1) of the 2001 Directive applies.

Administrative variation application

3.  An administrative variation application is an application by a traditional herbal registration holder to vary a traditional herbal registration where the variation applied for falls within one of the following sub-paragraphs—

(a) a change of either or both of the name and the address of the holder of the registration;

(b) a change of either or both of the name and the address of a manufacturer, assembler, storer or distributor named in the registration where the change has been occasioned by the taking over of an existing business, whether by purchase, merger or otherwise, and any change of address does not involve a change of the site of manufacture, assembly or storage or of the site from which distribution takes place; or

(c) the removal from the registration of details of one or more of the sites of manufacture, assembly or storage or of the sites from which distribution takes place.

Extension application

4.  An extension application is an application—

(a) for an extension of a marketing authorization within the meaning of Article 2(4) of EC Regulation No. 1234/2008; and

(b) which includes the result of pre-clinical tests or clinical trials as specified in Article 8(3)(i) of the 2001 Directive.

Complex application

5.  A complex application is an application, other than a major application, for a marketing authorization where the application falls within one or more of the following sub-paragraphs—

(a) the application relates to a medicinal product which is intended to be used in accordance with an indication for use in respect of a new category of patients or as treatment for a new category of disease;

(b) the application relates to a medicinal product containing a new combination of active ingredients that have not previously been included in that combination in a medicinal product in respect of which a marketing authorization (other than a product licence of right) has previously been granted;

(c) the application relates to a medicinal product containing a new excipient;

(d) the application relates to a medicinal product that is intended to be administered by a route of administration different from that used in relation to any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorization (other than a product licence of right) has previously been granted;

(e) the application relates to a medicinal product containing an active ingredient the manufacture of which involves a route of synthesis (or, in the case of a medicinal product not synthetically produced, a method of manufacture) different from that used in the manufacture of the active ingredient of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorization (other than a product licence of right) has previously been granted;

(f) the application relates to a medicinal product which is a controlled release preparation and is not a simple application;

(g) the application relates to a sterile medicinal product the manufacture of which involves a method of sterilisation different from that used in the manufacture of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorization (other than a product licence of right) has previously been granted;

(h) the application relates to a sterile medicinal product the container of which is directly in contact with the medicinal product and is made from different material from the container of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorization (other than a product licence of right) has previously been granted;

(i) unless a European Pharmacopoeia certificate of suitability covering the active ingredient has been submitted with the application, the application names as manufacturer of the active ingredient of the medicinal product in question a different manufacturer from the manufacturer of that active ingredient included in a medicinal product in respect of which a marketing authorization (other than a product licence of right) has previously been granted;

(j) the application relates to a medicinal product which is an influenza vaccine and in respect of which the manufacturer or the manufacturing process is different from that specified in any other marketing authorization which the applicant holds in respect of that product;

(k) the application is for the grant of a marketing authorization for a medicinal product which is an influenza vaccine, except where it relates only to an influenza vaccine containing a different strain or strains from that specified in any other marketing authorization which the applicant holds;

(l) the application is for the grant of a marketing authorization for a medicinal product which is to be delivered by way of a metered dose inhaler;

(m) the application is for the grant of a marketing authorization for a medicinal product which is in a powdered form and is to be delivered by way of inhalation;

(n) the application relates to a medicinal product—

(i) which is administered to the site of action or absorption by a method which has not previously been authorised in relation to any authorised medicinal product which contains the same active ingredient as the product in question; and

(ii) in respect of that other product, a marketing authorization (other than a product licence of right) has previously been granted;

(o) the application is an application for a marketing authorization to which Article 10(3) of the 2001 Directive applies;

(p) the application is an application where the sole or primary evidence for the safety and efficacy of the medicinal product consists of published scientific literature;

(q) the application is an extension application;

(r) the application—

(i) is not an application in accordance with Article 10, 10a or 10c of the 2001 Directive; and

(ii) includes the results of pre-clinical tests or clinical trials as specified in Article 8(3)(i) of the 2001 Directive; or

(s) the application is an application for a marketing authorization to which the first sub-paragraph of paragraph 3 of Part II of Annex I to the 2001 Directive applies.

Complex registration application

6.  A complex registration application is an application for a traditional herbal registration relating to a medicinal product containing an active ingredient that has not previously been included as an active ingredient in a medicinal product in respect of which a marketing authorization (other than a product licence of right) or a traditional herbal registration has previously been granted.

Complex variation application

7.  A complex variation application is an application by a traditional herbal registration holder to vary a traditional herbal registration which relates to a change in the formulation of a medicinal product comprising one or more of the following changes—

(a) a change in that product's active ingredients which involves the addition of one or more active ingredients which are active ingredients from a new source;

(b) a change in that product's excipients which involves the addition of one or more TSE risk excipients from a new source; or

(c) a change which involves the addition of one or more vitamins or minerals which are vitamins or minerals from a new source where no European Pharmacopoeia certificate of suitability covering those vitamins or minerals has been submitted with the application.

Decentralised procedure application

8.  A decentralised procedure application is a major application, a complex application, a standard application or a simple application for a marketing authorization for a medicinal product in respect of which at the time of the application—

(a) a marketing authorization has not been granted in any EEA State; and

(b) an application for a marketing authorization has been made in more than one EEA State pursuant to the procedure in Title III, Chapter 4 of the 2001 Directive.

Extended Type II Complex Variation Application

9.  An Extended Type II Complex Variation Application is an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) so that the medicinal product is indicated for use—

(a) in a therapeutic area for which the product was not previously indicated for use; or

(b) in respect of an organ, or any other part, of the human body for which the product was not previously indicated for use, if the application is supported by data which comprises or includes the results of clinical trials or physico-chemical, microbiological or pharmacological and toxicological tests.

Major application

10.  A major application is an application for a marketing authorization made to the licensing authority on the grounds that a medicinal product contains a new active ingredient.

Mutual recognition procedure incoming application

11.  A mutual recognition procedure incoming application is a major application, a complex application or a standard application for a marketing authorization for a medicinal product in respect of which—

(a) a marketing authorization has already been granted in another EEA State; and

(b) recognition of that marketing authorization is sought from the licensing authority by way of the grant of a marketing authorization in the United Kingdom, pursuant to the procedure in Title III, Chapter 4 of the 2001 Directive.

New excipient variation application

12.  A new excipient variation application is an application, other than a complex variation application, by a traditional herbal registration holder to vary a traditional herbal registration which relates to a change in the formulation of the medicinal product to add a new excipient.

New indication variation application

13.  A new indication variation application is an application to vary a marketing authorization for a national homoeopathic product, so that product is indicated for a therapeutic use not previously covered by that authorization.

Parallel Import Licence application

14.—(1) An application for a Simple Parallel Import licence means an application for a parallel import licence in respect of a proposed importation of a medicinal product (“P”) which is similar to a medicinal product (“R”) in respect of which a marketing authorisation has already been granted in the United Kingdom.

(2) For the purposes of sub-paragraph (1) “similar” means—

(a) the manufacturer of P and the manufacturer of R are either the same company or belong to the same group of companies or, in the case of independent companies, agreements have been concluded with the same licensor; and

(b) product P and R are manufactured according to the same formulation, using the same active ingredients, have the same pharmaceutical form and have no differences that will result in a difference in the therapeutic effect.

(3) An application for a Complex Parallel Import licence means an application for a parallel import licence which is not a Simple Parallel Import licence and the application is in respect of a medicinal product—

(a) containing a new excipient;

(b) containing an active ingredient the manufacture of which involves a route of synthesis (or, in the case of a medicinal product not synthetically produced, a method of manufacture) different from that used in the manufacture of the active ingredient of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorization (other than a product licence of right) has previously been granted;

(c) which is a controlled release preparation;

(d) which is a sterile medicinal product the manufacture of which involves a method of sterilisation different from that used in the manufacture of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorization (other than a product licence of right) has previously been granted;

(e) which is a sterile medicinal product the container of which is directly in contact with the medicinal product and is made from different material from the container of any medicinal product which contains the same active ingredient as the product in question and in respect of which a marketing authorization (other than a product licence of right) has previously been granted;

(f) containing an active ingredient which, unless that active ingredient is covered by a European Pharmacopoeia certificate of suitability, is not manufactured by a manufacturer of the active ingredient which is included in the medicinal product in respect of which a marketing authorization (other than a product licence of right) has previously been granted;

(g) which is an influenza vaccine;

(h) which is to be delivered by way of a metered dose inhaler;

(i) which is in powder form and is to be delivered by inhalation;

(j) which falls within the description of the medicinal product set out in Article 10(3) of the 2001 Directive;

(k) where the sole or primary evidence for the safety and efficacy of that product consists of published scientific literature;

(l) in respect of which a marketing authorization has not been made pursuant to Article 10, 10a or 10c of the 2001 Directive by the competent authority in the Member State of exportation, and the application includes the results of pre-clinical tests or clinical trials within the meaning of Article 8(3)(i) of the 2001 Directive; or

(m) in respect of which a marketing authorization to which the first sub-paragraph of paragraph 3 of Part II of Annex I to the 2001 Directive applied in the Member State of exportation.

(4) An application for a Standard Parallel Import licence means an application for a parallel import licence which is not a Complex Parallel Import licence or a Simple Parallel Import licence.

(5) An application shall not fall within the meaning of sub-paragraph (1), (3) or (4) where the applicant and the holder of the marketing authorization in the Member State of exportation in respect of which the medicinal product in question relates are a parent undertaking and subsidiary undertaking within the meaning of section 1162 (taken together with section 1161 of, and Schedule 7 to) the Companies Act 2006 M1 .

Marginal Citations

M1 2006 c.46.

Reclassification variation application

15.  A reclassification variation application is an application for variation of a marketing authorization which has the effect that a medicinal product to which that authorization relates—

(a) is to be available only from a pharmacy or on general sale, where previously it was available only on prescription; or

(b) is to be available on general sale, where previously it was available only from a pharmacy.

Reduced registration application

16.—(1) A reduced registration application category I is an application other than a complex registration application for a traditional herbal registration relating to a medicinal product which is presented in the form of a herbal tea.

(2) A reference to a reduced registration application category II means an application, other than a complex registration application, or a traditional herbal registration where the application falls within one of the descriptions specified in sub-paragraphs (a) to (d) as follows—

(a) the application relates to a medicinal product which is presented in the form of a herbal tincture;

(b) the application relates to a medicinal product which is presented in the form of an essential oil;

(c) the application relates to a medicinal product which is presented in the form of a fatty oil; or

(d) the application relates to a medicinal product which contains only herbal substances in a capsule.

Simple application

17.  A simple application is an application—

(a) for a marketing authorization to which Article 10c of the 2001 Directive applies; or

(b) made no later than three months after the expiry of a marketing authorization, which is for a marketing authorization containing identical provisions to those contained in the expired authorization and which is made by the person who held the expired authorization.

Standard application

18.  A standard application is any application for the grant of a marketing authorization which is not a major application, a complex application, a simple application, a change of ownership application or an application for a parallel import licence.

Standard registration application

19.  A standard registration application means any application for the grant of a traditional herbal registration which is not a complex registration application, a reduced registration application category I, a reduced registration application category II or a change of ownership application.

Standard variation application

20.  A standard variation application is an application by a traditional herbal registration holder to vary a traditional herbal registration which is not a complex variation application, a new excipient variation application or an administrative variation application.

Standard variation application for a homoeopathic medicinal product

21.  A standard variation application for a homoeopathic medicinal product is an application for a variation of a marketing authorization for a national homoeopathic product which requires—

(a) the replacement of an excipient used in the manufacture of the product;

(b) the replacement of a reagent indirectly associated with the manufacturing process of the product or which disappears from that process with a comparable reagent;

(c) a change to the qualitative composition of the container or other form of packaging immediately in contact with the product;

(d) a change to the method of manufacture of a homoeopathic stock included in the product;

(e) a change to the specification of any reagent or excipient used in the manufacture of the product;

(f) a change to the finished product specification of the product;

(g) a change to the test procedure for any raw material used in the manufacture of the product;

(h) a change to the test procedure for the product;

(i) a change to the test procedure for the container or other form of packaging immediately in contact with the product;

(j) a change to comply with a supplement to the European Pharmacopoeia or any national pharmacopoeia of a Member State;

(k) a change to the shape of the container in which the product may be placed on the market;

(l) an additional pack size in which the product may be placed on the market;

(m) a change to the approved storage conditions for the product;

(n) a change to the shelf life of an unopened container of the product after the container has been opened for the first time;

(o) a change to the dimensions of an approved dosage form of the product (for example, tablets); or

(p) a change following modification to the manufacturing authorization referred to in Article 40 of the 2001 Directive.

Type IB and Type II Applications

22.—(1) A Type IB Application is an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) which is a “minor variation of type IB” within the meaning of Article 2(5) of EC Regulation No. 1234/2008.

(2) A Type II Application is an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) which is not—

(a) a reclassification variation;

(b) a Type IA Application;

(c) a Type IB Application;

(d) a Type II Complex Variation Application;

(e) an Extended Type II Complex Variation Application; or

(f) an application for an extension of a marketing authorization within the meaning of Article 2(4) of EC Regulation No. 1234/2008.

(3) For the purposes of sub-paragraph (2)(b), a Type IA Application means an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) which is a “minor variation of type IA” within the meaning of Article 2(2) of EC Regulation No. 1234/2008.

Type II Complex Variation Application

23.  A Type II Complex Variation Application is an application for a variation of a marketing authorization, other than an Extended Type II Complex Variation Application, which relates to a change—

(a) in the formulation of a medicinal product comprising one or more of the following changes, other than a change to which paragraph 1 (changes to active substances) or paragraph 2 (changes to strength, pharmaceutical form and route of administration) of Annex I to EC Regulation No. 1234/2008 applies—

(i) a change which necessitates in-vivo bioavailability studies to be performed on that product;

(ii) a change in that product's preservative system; or

(iii) a change in that product's excipients which significantly affects the pharmaceutical or the therapeutic properties of that product; or

(b) which is considered a “major variation of type II” within the meaning of Article 2(3) of EC Regulation No. 1234/2008 and which is—

(i) supported by data which comprises or includes the results of clinical trials or physicochemical, biological, microbiological or pharmacological and toxicological tests; or

(ii) accompanied by evidence relating to post-marketing experience which is information of any type described in paragraph 5.2.6 of Part I of Annex I to the 2001 Directive (clinical documentation); or

(c) in the composition, manufacture or use of a medicinal product to which—

(i) sub-paragraph (c), (e), (g), (h), (j) or (n) of the definition of complex application in paragraph 5 of this Schedule would apply where an application for a marketing authorization is made in respect of a medicinal product; or

(ii) sub-paragraph (i) of that definition would so apply and the change is not a minor variation of type IA or a minor variation of type IB within the meaning of EC Regulation No. 1234/2008.

PART 2 Capital Fees for Applications for Authorizations, Licences, Registrations and Certificates

Marketing authorizations

24.—(1) Unless paragraphs 25, 26, 28 or 29 apply, the fee payable under regulation 12(1)(a) in connection with an application for a marketing authorization of a kind described in column 1 of the following table is—

(a) if the application is an eCTD format application, the fee specified in the corresponding entry in column 2 of that table; or

(b) if the application is not an eCTD format application, the fee specified in the corresponding entry in column 3 of that table.

Fees for marketing authorization applications

Column 1 Kind of application							Column 2 Fee payable if application is in eCTD format	Column 3 Fee payable if application is not in eCTD format
1. Major application
	(a)			in respect of an application relating to an orphan medicinal product to which point 6 of Part 2 of Annex 1 to the 2001 Directive applies			£32,135	£33,709
	(b)			which is a mutual recognition procedure incoming application			£67,468	£70,774
	(c)			which is a European reference product application			£67,468	£70,774
	(d)			which is a decentralised procedure application where the United Kingdom is a concerned Member State			£96,797	£101,541
	(e)			which is a decentralised procedure application where the United Kingdom is a reference Member State			£147,479	£154,706
	(f)			in any other case			£100,252	£105,146
2. Complex application
			(a)		which is a mutual recognition procedure incoming application		£18,732	£19,650
			(b)		which is a European reference product application		£18,732	£19,650
			(c)		which is a decentralised procedure application where the United Kingdom is a concerned Member State		£26,762	£28,073
			(d)		which is a decentralised procedure application where the United Kingdom is a reference Member State		£43,195	£45,312
			(e)		in any other case		£27,716	£29,068
3. Standard application
			(a)		which is a mutual recognition procedure incoming application		£6,864	£7,200
			(b)		which is a European reference product application		£6,864	£7,200
			(c)		which is a decentralised procedure application where the United Kingdom is a concerned Member State		£9,812	£10,294
			(d)		which is a decentralised procedure application where the United Kingdom is a reference Member State		£18,980	£19,910
			(e)		in any other case		£10,162	£10,659
4. Simple application
			(a)		which is a decentralised procedure application where the United Kingdom is a concerned Member State		£2,771	£2,906
			(b)		which is a decentralised procedure application where the United Kingdom is a reference Member State		£9,788	£10,303
			(c)		in any other case		£2,771	£2,906
5. Parallel import licence applications
		(a)				in respect of a simple parallel import licence	Not applicable	£1,937
		(b)				in respect of a standard parallel import licence	Not applicable	£7,201
		(c)				in respect of a complex parallel import licence	Not applicable	£19,650
6. Change of ownership application							Not applicable	£478

(2) Each reference in paragraphs 25, 27 and 28 to an amount payable under paragraph 24 in respect of an application refers to the amount payable under that paragraph in respect of an application of the kind in question.

Fees where application includes reclassification

25.—(1) Unless paragraph 27 applies, where an application, other than a major application, includes a reclassification element and—

(a) the reclassification falls within the category of application described in paragraph 15(a), an amount of—

(i) £12,961, if the application is an eCTD format application; or

(ii) £13,595, if the application is not an eCTD format application,

is payable in addition to the amount payable under paragraph 24 in respect of that application; or

(b) the reclassification falls within the category of application described in paragraph 15(b), an amount of—

(i) £8,822, if the application is an eCTD format application; or

(ii) £9,252, if the application is not an eCTD format application,

is payable in addition to the amount payable under paragraph 24 in respect of that application.

(2) For the purposes of this paragraph, an application includes a reclassification element if—

(a) in the case of an application falling within the category described in paragraph 15(a), the medicinal product in question is to be available in the United Kingdom only from a pharmacy, unless there is an analogous medicinal product available in the United Kingdom only from a pharmacy or on general sale; or

(b) in the case of an application falling within the category described in paragraph 15(b), the medicinal product in question is to be available in the United Kingdom on general sale, unless there is an analogous medicinal product also so available.

(3) For the purposes of this paragraph, an analogous medicinal product is a medicinal product which has a United Kingdom marketing authorization or a European Union marketing authorization and which—

(a) has the same active ingredient, route of administration and use;

(b) has the same strength or a higher strength;

(c) has the same dosage or daily dosage, or a higher dosage or daily dosage; and

(d) is for sale or supply at the same quantity or a greater quantity,

as the medicinal product in relation to which the application is made.

Fees where person holds clinical trial certificate

26.  Where a major application is made by a person who holds a clinical trial certificate for a medicinal product which contains the same active ingredient as the medicinal product in respect of which the marketing authorization is applied for, the fee payable under regulation 12(1)(a) in connection with the application is reduced by the amount of the application fee paid for the clinical trial certificate.

Joint development

27.—(1) In this paragraph—

“joint development” means the development by two or more applicants for marketing authorizations relating to medicinal products—

(a)

each of which contains the same new active ingredient or combination of new active ingredients but with different proprietary names and which does not require separate consideration by a committee established under section 4 (establishment of committees) of the Act or by the Commission;

(b)

the development of which has been notified to the licensing authority at or before the time the application is submitted, as being a joint development undertaken by those applicants; and

(c)

in respect of which applications for marketing authorizations have been received by the licensing authority within one month of each other;

“primary applicant” means—

(a)

that party to a joint development who first makes an application for a marketing authorization relating to a new active ingredient which was the subject of that joint development; or

(b)

that party to a joint development who first makes an application for a marketing authorization relating to a different dosage form or strength of that new active ingredient;

“secondary applicant” means any party to a joint development, other than the primary applicant, who makes an application for a marketing authorization relating to the same new active ingredient as that which was the subject of the application made by the primary applicant.

(2) Unless sub-paragraph (3) applies, where a joint development relates to a medicinal product and two or more applications for marketing authorizations are submitted to the licensing authority by parties to the joint development, the fee payable under regulation 12(1)(a) is the amount payable in respect of a major application under paragraph 24 plus—

(a) in respect of the first or only marketing authorization applied for by that secondary applicant, the amount payable in respect of a complex application under paragraph 24;

(b) in respect of each additional marketing authorization applied for by that secondary applicant which relates to a medicinal product of the same dosage form, the amount payable in respect of a standard application under paragraph 24;

(c) in respect of the first additional marketing authorization applied for by that secondary applicant relating to that medicinal product which is of a different dosage form, the amount payable in respect of a complex application under paragraph 24 and in respect of any other such application by that secondary applicant, the amount payable in respect of a standard application under paragraph 24.

(3) Where a joint development relates to a medicinal product and an application for an additional marketing authorization is submitted by both the primary applicant and the secondary applicant, both or all of which applications relate to identical dosage forms and strengths of the product—

(a) where the amount payable by the primary applicant is that in respect of a complex application, the fee payable under regulation 12(1)(a) by the secondary application is that in respect of a standard application under paragraph 24;

(b) where the amount payable by the primary applicant is that in respect of a standard application, the fee payable under regulation 12(1)(a) by the secondary applicant is that in respect of a simple application under paragraph 24.

Application for multiple authorizations

28.—(1) Unless sub-paragraph (2), (3) or (4) applies, where an application for a marketing authorization is for more than one such authorization each relating to a medicinal product containing the same active ingredient or combination of ingredients, the fee payable under regulation 12(1)(a) is an amount equal to the aggregate of the amounts payable under paragraph 24 in respect of a separate application for each such authorization.

(2) If the application is a major application, the amount payable is the amount payable in respect of a major application under paragraph 24 plus—

(a) in respect of each additional marketing authorization applied for which relates to a medicinal product of a different dosage form with a different route of administration, the amount payable in respect of a complex application under paragraph 24;

(b) in respect of each additional marketing authorization applied for which relates to a medicinal product of a different dosage form but with the same route of administration, the amount payable in respect of a standard application under paragraph 24; and

(c) in respect of each additional marketing authorization applied for which relates to a medicinal product of the same dosage form but of a different strength of active ingredient or different combination of active ingredients, the amount payable in respect of a standard application under paragraph 24.

(3) If the application is a complex application, the amount payable is the amount payable in respect of a complex application under paragraph 24 plus—

(a) in respect of each additional marketing authorization applied for which relates to a medicinal product of a different dosage form with a different route of administration, the amount payable in respect of a complex application under paragraph 24;

(b) in respect of each additional marketing authorization applied for which relates to a medicinal product of a different dosage form but with the same route of administration, the amount payable in respect of a standard application under paragraph 24; and

(c) in respect of each additional marketing authorization applied for which relates to a medicinal product of the same dosage form but of a different strength of active ingredient or different combination of active ingredients, the amount payable in respect of a standard application under paragraph 24.

(4) If the application includes any applications for marketing authorizations that include a reclassification element, the amount payable is the amount payable in accordance with sub-paragraphs (1) to (3) plus—

(a) in respect of the first marketing authorization applied for that includes a reclassification element, the additional amount payable in respect of the relevant category of reclassification variation application under paragraph 25(1); and

(b) in respect of each other marketing authorization applied for that includes a reclassification element, £832, except in the case of an eCTD format application in which case the additional amount payable is £794.

(5) For the purposes of sub-paragraph (4), a “reclassification element” has the meaning given in paragraph 25(2).

Authorisation for a national homoeopathic product

29.—(1) In this paragraph—

“formulation” does not include the formulation of a homoeopathic stock;

“homoeopathic marketing authorization” means a marketing authorization granted by the licensing authority in respect of a national homoeopathic medicinal product;

“identical” means—

(a)

in relation to the formulation of the product, identical as regards the requirements in respect of composition, preparation and testing; and

(b)

in relation to a homoeopathic stock, identical as regards the source, composition and preparation of the stock and the test which it is required to undergo;

“product” includes a series of products each of which is prepared from identical homoeopathic stocks;

“repeat formulation” means—

(a)

the formulation of a product which is identical to the formulation of another product—

(i)

in respect of which the applicant holds a certificate of registration or a homoeopathic marketing authorization; or

(ii)

to which the applicant has, by the holder of the certificate of registration or the homoeopathic marketing authorization which relates to it, been authorised in writing to make reference for the purposes of this application; or

(b)

where more than one application is made by the same applicant on the same occasion in respect of products of identical formulations, for the purposes of the second and any subsequent of those applications which the licensing authority considers, the formulation of the product to which the first of those applications which is considered by the licensing authority relates; and

“repeat stock” means a homoeopathic stock which is identical to another homoeopathic stock which is used in the preparation of a product in respect of which—

(a)

the applicant holds a certificate of registration or a homoeopathic marketing authorization; or

(b)

another person holds a certificate of registration or a homoeopathic marketing authorization to which, for the purposes of his application, the applicant has been authorised in writing to make reference by the person (or, if more than one, each of the persons) who supplied information to the licensing authority in connection with the application for the marketing authorization which relates to that product.

(2) This paragraph does not apply to an application which is a mutual recognition procedure incoming application or a decentralised procedure application.

(3) In connection with an application for a marketing authorization for a national homoeopathic product prepared from not more than 5 homoeopathic stocks, the fee payable under regulation 12(1)(a) is the amount set out in column 2 in the table below opposite the description in column 1 appropriate to that application.

(4) In connection with any other application for a marketing authorization for a national homoeopathic product, the fee payable under regulation 12(1)(a) shall be the amount set out in column 3 in the table below opposite the description in column 1 appropriate to that application.

Fees for homoeopathic marketing authorization applications

Column 1			Column 2	Column 3
Description of application			Fee for applications in respect of products prepared from not more than 5 homoeopathic stocks	Fee for other applications
1. An application in respect of a product which is both prepared solely from repeat stocks and is of a repeat formulation			£558	£791
2. An application in respect of a product which is either—			£874	£1,096
	(a)	prepared solely from repeat stocks; or
	(b)	is of a repeat formulation
3. Any other application			£1,176	£1,418

(5) Each reference in sub-paragraphs (6) to (8) to an amount payable under sub-paragraph (3) or (4) in respect of an application refers to the amount payable under that sub-paragraph in respect of an application of the kind in question.

(6) Where an application relates to a national homoeopathic product which is manufactured using a method of sterilisation—

(a) not used in the manufacture of a medicinal product in respect of which a marketing authorization (other than a product licence of right), a certificate of registration or a traditional herbal registration has previously been granted; and

(b) not referred to in the European Pharmacopoeia or any national pharmacopoeia of a Member State,

an amount of £2,328 is payable in addition to the amount payable under sub-paragraph (3) or (4) in respect of that application.

(7) Where an application relates to a national homoeopathic product which contains one or more new excipients, an amount of £7,766 is payable in addition to the amount payable under sub-paragraph (3) or (4) in respect of that application.

(8) Where an application relates to a national homoeopathic product which contains one or more TSE risk ingredients from a new source or TSE risk excipients from a new source, an amount of £686 is payable in addition to the amount payable under sub-paragraph (3) or (4) in respect of that application.

Manufacturer's licences and authorisations

30.—(1) The fee payable under regulation 12(1)(a) in connection with an application for a manufacturer's licence or a manufacturing authorisation is—

(a) £178, in a case to which sub-paragraph (2) applies;

(b) £335, in the case of a change of ownership application; and

(c) £3,057, in any other case.

(2) This sub-paragraph applies to the case of an application for a manufacturer's licence which is limited solely to the manufacture or assembly of medicinal products which are to be sold or supplied in circumstances to which article 2(2)(i)(e) (exemptions for certain special manufactured products) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 M2 applies.

Marginal Citations

M2 S.I. 1971/1450 to which there are no relevant amendments.

Wholesale dealer's licences

31.—(1) Unless sub-paragraph (2) or (6) applies, the fee payable under regulation 12(1)(a) in connection with an application for a wholesale dealer's licence is £1,754.

(2) Where this sub-paragraph applies, the fee payable under regulation 12(1)(a) is £751.

(3) Subject to sub-paragraph (5), sub–paragraph (2) applies where an application for a wholesale dealer's licence—

(a) relates to anything done in a registered pharmacy by or under the supervision of a pharmacist and amounts to wholesale dealing, where such dealing constitutes no more than 15% of the total turnover of the sale of authorised medicinal products carried on at that pharmacy;

(b) does not relate to anything done in a registered pharmacy but where the total turnover of the sale by way of wholesale dealing of authorised medicinal products does not exceed £35,000; or

(c) relates only to medicinal products falling within a description or class specified in an Order which is for the time being in force made under section 51(1) (general sale lists) of the Act M3 .

(4) For the purposes of sub-paragraphs (3)(a) and (b), “turnover” means the gross amount of the total sales made during the period of 12 months preceding the date of the application.

(5) Sub-paragraph (2) does not apply where the applicant has not held a wholesale dealer's licence during the 12 month period preceding the date of the application unless at the time of making the application it is reasonable for the applicant to believe—

(a) in the case of an application for a wholesale dealer's licence which relates to anything done in a registered pharmacy by or under the supervision of a pharmacist and which amounts to wholesale dealing, that such dealing will constitute no more than 15% of the gross amount of the total sales of authorised medicinal products likely to be made in the period of 12 months following the grant of the licence; or

(b) in the case of an application for a wholesale dealer's licence which does not relate to anything done in a registered pharmacy, that the gross amount of total sales of authorised medicinal products likely to be made in the period of 12 months following the grant of the licence will not exceed £35,000;

and that applicant so informs the licensing authority when the application is made.

(6) The fee payable under regulation 12(1)(a) in connection with a change of ownership application is £388.

Marginal Citations

M3 Section 51(1) has been amended by S.I. 2006/2407.

Clinical trial authorisations

32.—(1) Unless sub-paragraphs (3) and (4) apply, the fee payable under regulation 12(1)(a) in connection with an application for a clinical trial authorisation for a clinical trial of a kind described in column 1 of the following table is the fee specified in the corresponding entry in column 2 of that table.

Fees for clinical trial authorisation applications

Column 1 Kind of clinical trial	Column 2 Fee payable
Phase I trial	£2,255
Phase II or Phase III trial where the medicinal product being tested is unknown to the licensing authority	£4,244
Phase II or Phase III trial where the product being tested is known to the licensing authority	£3,448
Phase IV trial	£265

(2) For the purposes of that table, a medicinal product is known to the licensing authority if—

(a) the product has an EU marketing authorization; or

(b) the product does not have an EU marketing authorization, but where—

(i) another pharmaceutical form or strength of that product has an EU marketing authorization and the medicinal product is supplied for the purposes of the clinical trial by the holder of that authorization;

(ii) another medicinal product containing the same active substance has an EU marketing authorization and the medicinal product is supplied for the purposes of the clinical trial by the manufacturer of that other product; or

(iii) a clinical trial in which that product is, or was, being tested or used has been authorised by the licensing authority in accordance with Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use M4 .

(3) Where the application is in relation to a clinical trial in which the medicinal products being tested or used are the same as those being tested or used in a clinical trial—

(a) in respect of which the applicant made a request for authorisation; and

(b) which has been authorised by the licensing authority for the purposes of the Clinical Trials Regulations,

the fee payable in connection with that application is £265.

(4) Where—

(a) the medicinal product to be tested in the clinical trial to which the application relates has been used in another clinical trial that has been authorised, or is to be treated as having been authorised, by the licensing authority for the purposes of the Clinical Trials Regulations; and

(b) the sponsor of that other trial authorises the licensing authority to refer to the dossier submitted in relation to that product in accordance with paragraph 11 of Schedule 3 to those Regulations,

the fee payable in connection with that application is £265.

Marginal Citations

M4 OJ No. L 121, 1.5.2001, p.34. This Directive has been amended by Regulation (EC) No. 1901/2006 (OJ No. L 378, 27.12.2006, p.1), to which amendments which are not relevant to these Regulations have been made.

Traditional herbal registrations

33.—(1) Subject to sub-paragraphs (3) to (6), the fee payable under regulation 12(1)(a) in connection with an application for a traditional herbal registration of a kind described in column 1 of the following table is the fee specified in the corresponding entry in column 2 of that table—

Fee for application for traditional herbal registration

Column 1				Column 2
Kind of application				Fee payable
1. Complex registration application
	(a)		in respect of a medicinal product containing a single active ingredient	£5,237
	(b)		in any other case	£7,857
2. Standard registration application
	(a)		in respect of a medicinal product containing 3 or fewer active ingredients	£2,619
	(b)		in any other case	£3,928
3. Reduced registration application category II
		(a)	in respect of a medicinal product containing 3 or fewer active ingredients	£873
		(b)	in any other case	£1,310
4. Reduced registration application category I
		(a)	in respect of a medicinal product containing 3 or fewer active ingredients	£583
		(b)	in any other case	£873
5. Change of ownership application				£478

(2) Each reference in sub-paragraphs (3) to (6) to an amount payable under sub-paragraph (1) in respect of an application refers to the amount payable under that sub-paragraph in respect of an application of the kind in question.

(3) Where an application relates to a medicinal product which contains one or more vitamins or minerals which are vitamins or minerals from a new source, a fee of—

(a) £1,164, if European Pharmacopoeia certificates of suitability covering all the vitamins or minerals which are a vitamin or mineral from a new source have been submitted with the application; or

(b) £2,328, in any other case,

is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.

(4) Where an application relates to a medicinal product which contains one or more new excipients, an amount of £7,767 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.

(5) Where an application relates to a medicinal product which contains one or more TSE risk excipients from a new source, an amount of £690 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.

(6) Where an application relates to a medicinal product which is a sterile medicinal product, an amount of £2,328 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.

PART 3 Capital Fees for Assistance in Obtaining Marketing Authorizations in Other EEA States

Outgoing mutual recognition applications

34.—(1) The fee payable under regulation 16 (application to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Title III, Chapter 4 of the 2001 Directive of a single United Kingdom marketing authorization in another EEA State or in other EEA States) is the fee specified in sub-paragraphs (2) to (5).

(2) In the case where the application to the licensing authority relates to a medicinal product for which a marketing authorization was granted in the United Kingdom (the application relating to that authorization is referred to in this paragraph as the “original application”) and the original application had been a major application or would fall within the meaning of a major application, in respect of—

(a) the first application for regulatory assistance (“the first application”), the fee is £44,934;

(b) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as the first application, the fee is £2,769;

(c) each subsequent application for regulatory assistance (“subsequent application”), the fee is £29,516; and

(d) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as any subsequent application, the fee is £2,769.

(3) In the case where the application to the licensing authority relates to a medicinal product for which a marketing authorization was granted in the United Kingdom and the original application had been a complex application or would fall within the meaning of a complex application, in respect of—

(a) the first application for regulatory assistance (“the first application”), the fee is £11,623;

(b) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as the first application, the fee is £2,769;

(c) each subsequent application for regulatory assistance (“subsequent application”), the fee is £7,709; and

(d) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as any subsequent application, the fee is £2,769.

(4) In the case where the application to the licensing authority relates to a medicinal product for which a marketing authorization was granted in the United Kingdom and the original application had been a standard application or would fall within the meaning of a standard application, in respect of—

(a) the first application for regulatory assistance (“the first application”), the fee is £4,628;

(b) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as the first application, the fee is £2,769;

(c) each subsequent application for regulatory assistance (“subsequent application”), the fee is £3,855; and

(d) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as any subsequent application, the fee is £2,769.

(5) In the case where the application to the licensing authority relates to a medicinal product for which a marketing authorization was granted in the United Kingdom and the original application had been a simple application or would fall within the meaning of a simple application, in respect of—

(a) the first application for regulatory assistance (“the first application”), the fee is £2,769;

(b) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as the first application, the fee is £2,769;

(c) each subsequent application for regulatory assistance (“subsequent application”), the fee is £2,769; and

(d) any other application for regulatory assistance meeting the condition in sub-paragraph (6) and made at the same time as any subsequent application, the fee is £2,769.

(6) The condition referred to in sub-paragraphs (2) to (5) is that all applications fall within the meaning given to a set of applications in regulation 15.

PART 4 Capital Fees for Applications for Variations of Authorizations, Licences and Registrations

Marketing authorizations

35.—(1) Subject to paragraphs 36 to 39 and 46 to 48, the fee payable under regulation 18(1) in connection with an application for a variation to the terms of a marketing authorization of a kind described in column 1 of the appropriate table is—

(a) if the application is in an eCTD format application, the fee specified in the corresponding entry in column 2 of the appropriate table;

(b) if the fee is not in an eCTD format application, the fee specified in the corresponding entry in column 3 of that table.

(2) In sub-paragraph (1), the appropriate table is—

(a) in respect of an application for a variation of a marketing authorization which is within the scope of EC Regulation No. 1234/2008 M5 , Table 1;

(b) in respect of a UK national variation application, Table 2;

(c) in respect of a reclassification variation application, Table 3.

(3) In Table 1, “reference authority” has the meaning given in Article 20(2)(b) of EC Regulation No. 1234/2008.

(4) In Table 2, “UK national variation application” means a variation to a notification of, or an application for, a variation to the terms of a marketing authorization which is not within the scope of EC Regulation No. 1234/2008 and which—

(a) is a change set out in the document entitled “UK National MA Variations Guidance” published by the licensing authority and available on its website on 30th November 2009 M6 ; and

(b) complies with the procedures and conditions to be fulfilled as set out in that document,

and the expressions “National Type 1B Application”, “National Type II Application”, “National Type II Complex Variation Application”, “National Type II Extended Complex Variation Application”, “National Type IB Minor Variation Group Application”, “National Type II Major Variation Group Application” and “National Type II Major Variation Complex Group Application” shall be construed accordingly.

Table 1

Fees for applications for variations of marketing authorizations falling within the scope of EC Regulation No. 1234/2008

Column 1 Kind of variation				Column 2 Fee payable if in eCTD format	Column 3 Fee payable for application not in eCTD format
1. Application for a single kind variation
	(a)	Type IB Application where—
		(i)	the UK is a concerned Member State	£300	£318
		(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing	£594	£622
	(b)	Type II Application where—
		(i)	the UK is a concerned Member State	£794	£832
		(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing	£962	£1,008
	(c)	Type II Complex Variation Application where—
		(i)	the UK is a concerned Member State	£8,981	£9,420
		(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing	£15,571	£16,332
	(d)	Extended Type II Complex Variation Application where—
		(i)	the UK is a concerned Member State	£27,716	£29,068
		(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing	£38,744	£40,634
2. Applications for a Group
	(a)	Minor Variation (Type IB) Group Application where—
		(i)	the UK is a concerned Member State	£672	£708
		(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing	£1,324	£1,394
	(b)	Major Variation (Type II) Group Application where—
		(i)	the UK is a concerned Member State	£1,786	£1,880
		(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing	£2,158	£2,274
	(c)	Major Variation (Type II) Complex Group Application where—
		(i)	the UK is a concerned Member State	£9,738	£10,252
		(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing	£16,465	£17,332
	(d)	Major Variation (Type II) Extended Complex Group Application where—
		(i)	the UK is a concerned Member State	£28,401	£29,896
		(ii)	the UK is the reference Member State or the licensing authority is the reference authority for work sharing	£39,693	£41,612

Table 2

Fees for UK national variation applications

Column 1 Kind of national variation	Column 2 Fee payable if in eCTD format	Column 3 Fee payable for application not in eCTD format
1. National Type 1B Application	£300	£318
2. National Type II Application	£794	£832
3. National Type II Complex Variation Application	£8,981	£9,420
4. National Type II Extended Complex Variation Application	£27,716	£29,068
5. National Type IB Minor Variation Group Application	£672	£708
6. National Type II Major Variation Group Application	£1,786	£1,880
7. National Type II Major Variation Complex Group Application	£9,738	£10,252
8. National Type II Major Variation Extended Complex Group Application	£28,401	£29,896

Table 3

Fees for reclassification variation applications

Column 1 Kind of reclassification variation			Column 2 Fee payable if in eCTD format	Column 3 Fee payable for application not in eCTD format
Application falling within the category described in—
	(a)	paragraph 15(a)	£12,961	£13,595
	(b)	paragraph 15(b)	£8,822	£9,252

Marginal Citations

M5 See Article 1 of the Regulation.

M6 A copy of the guidance can be downloaded from the licensing authority's website at www.mhra.gov.uk or obtained by writing to the licensing authority at Market Towers, 1, Nine Elms Lane, London, SW8 5NQ or by sending an email to [e-mail].

Variation of marketing authorizations

36.—(1) Subject to sub-paragraph (3), if an application to vary a marketing authorization of a kind described in sub-paragraph (2) is—

(a) the first application to vary a marketing authorization;

(b) made within 5 years of the date of grant of the marketing authorization; and

(c) an application to authorise use of the medicinal product in a new therapeutic area,

the fee payable for that application is the fee payable under regulation 18(1) together with the difference between that fee and the fee which would have been payable if the application had been a major application.

(2) In this paragraph a marketing authorization is one which has been granted in accordance with an application to which point 6 of Part II of Annex I to the 2001 Directive applies or which is in respect of an orphan medicinal product.

(3) Sub-paragraph (1) and (2) shall not apply where the first application for variation of the marketing authorization relates to a therapeutic area, in respect of which the applicant would be entitled (had the applicant not already held a marketing authorization) to apply for a marketing authorization to which point 6 of Part II of Annex I to the 2001 Directive applies or which is in respect of an orphan medicinal product.

Reclassification of marketing authorizations

37.—(1) Where an application is a reclassification variation application to which this paragraph applies, the fee payable under regulation 18(1) in connection with the application for variation of a marketing authorization is £832, unless the application is an eCTD format application, in which case the fee payable under regulation 18(1) is £794.

(2) This paragraph applies to a reclassification variation application which would have the effect that a medicinal product to which the marketing authorization relates—

(a) is to be available only from a pharmacy (where previously it was available only on prescription), if an analogous medicinal product is available only from a pharmacy or on general sale; or

(b) is to be available on general sale (where previously it was available only on prescription or only from a pharmacy), if an analogous medicinal product is available on general sale.

(3) For the purposes of this paragraph, an analogous medicinal product is a medicinal product which has a United Kingdom marketing authorization or a European Union marketing authorization and which—

(a) has the same active ingredient, route of administration and use;

(b) has the same strength or a higher strength;

(c) has the same dosage or daily dosage, or a higher dosage or daily dosage; and

(d) is for sale or supply at the same quantity or a greater quantity,

as the medicinal product in relation to which the variation application is made.

Variation of marketing authorization: national homoeopathic products

38.  The fee payable under regulation 18(1) in connection with an application for a variation of a marketing authorization in respect of a national homoeopathic product is—

(a) £263, where the application is a standard variation application for a homoeopathic medicinal product;

(b) £408, where the application is a new indication variation application; and

(c) £133, for any other application.

Variation of parallel import licence

39.—(1) The fee payable under regulation 18(1) in connection with an application for variation of a parallel import licence is—

(a) £13,595 if, were the marketing authorization not a parallel import licence, the application for the variation would be a reclassification variation application falling within paragraph 15(a) and to which paragraph 37 of this Schedule does not apply;

(b) £9,252 if, were the marketing authorization not a parallel import licence, the application for the variation would be a reclassification variation application falling within paragraph 15(b) and to which paragraph 37 of this Schedule does not apply; and

(c) £386, in any other case other than where the variation applied for is an administrative variation.

(2) For the purposes of sub-paragraph (1)(c) an application for an administrative variation is where the variation applied for falls within one of the following paragraphs—

(a) a change of either or both of the name and the address of the holder of the licence;

(b) a change of either or both of the name and the address of a manufacturer, assembler, storer or distributor named in the licence where the change has been occasioned by the taking over of an existing business, whether by purchase, merger or otherwise, and any change of address does not involve a change of the site of manufacture, assembly or storage or of the site from which distribution takes place;

(c) the removal from the licence of details of one or more of the sites of manufacture, assembly or storage or of the sites from which distribution takes place;

(d) the removal from the licence of details of any of the activities to which the licence relates;

(e) the removal from the licence of details of any of the medicinal products which the holder of the licence is authorized to import;

(f) the addition or deletion of the name and address of the suppliers of the medicinal product to which the licence relates, or a change in the name, the address, or both the name and address, of the suppliers of that product; or

(g) unless paragraph 8 of Schedule 5 applies, a change consequential upon any or any combination of the following—

(i) a change of ownership of the United Kingdom marketing authorization in respect of which the parallel import licence was granted;

(ii) a change to the number of the United Kingdom marketing authorization in respect of which the parallel import licence was granted;

(iii) a change to the name of the holder of the United Kingdom marketing authorization in respect of which the parallel import licence was granted;

(iv) a change to the address of the holder of the United Kingdom marketing authorization in respect of which the parallel import licence was granted;

(v) a change to the number of the marketing authorization for the product in the country where the product originates;

(vi) a change of ownership of the marketing authorization for the product in the country where the product originates;

(vii) a change to the name of the holder of the marketing authorization for the product in the country where the product originates; or

(viii) a change to the address of the holder of the marketing authorization for the product in the country where the product originates,

where the change has been occasioned by the taking over of an existing business, whether by purchase, merger or otherwise, if the marketing authorization was not a parallel import licence, the application for that variation would be a reclassification variation application to which paragraph 38 of this Schedule applies.

Manufacturer's authorisations and licences

40.  Unless the fee in paragraph 41 is payable or paragraph 46 applies, the fee payable under regulation 18(1)(c) or (d) in connection with an application for variation of a manufacturing authorisation or a manufacturer's licence is—

(a) £250, in the case of a manufacturer's licence referred to in paragraph 30(2); and

(b) £500, in any other case.

Variation of manufacturer's authorisations and licences

41.  The fee payable under regulation 18(1)(c) or (d) in connection with an application for variation of a manufacturing authorisation or a manufacturer's licence is £250 in respect of each variation applied for which constitutes a change to the authorisation or licence not requiring an inspection or medical, scientific or pharmaceutical assessment.

Wholesale dealer's licences

42.  Unless the fee in paragraph 43 is payable or paragraph 46 applies, the fee payable under regulation 18(1)(c) in connection with an application for a variation of a wholesale dealer's licence is £473.

Variation of wholesale dealer's licence

43.  The fee payable under regulation 18(1)(c) in connection with an application for variation of a wholesale dealer's licence is £250 in respect of each variation applied for which consists of a change to the licence not requiring an inspection or medical, scientific or pharmaceutical assessment.

Clinical trial authorisations

44.—(1) The fee payable under regulation 19(1) in connection with a notice of amendment relating to amendment to the dossier accompanying a request for authorisation to conduct a clinical trial is—

(a) £265, if the amendments relate to one of the parts of the dossier specified in sub-paragraph (2) only;

(b) £530, if the amendments relate to two parts of the dossier specified in sub-paragraph (2) only; or

(c) £795, if the amendments relate to all three parts of the dossier specified in sub-paragraph (2) only.

(2) The parts of the dossier specified in sub-paragraph (1) are—

(a) the part containing the summaries of the chemical, pharmaceutical and biological data relating to the medicinal product tested or used in the trial;

(b) the part containing the summaries of the non-clinical, pharmacological and toxicology data on that product; and

(c) the part containing the summaries of the available data from previous clinical trials of, and human experience with, that product.

Traditional herbal registrations

45.  Unless paragraph 46 applies, the fee payable under regulation 18(1) in connection with an application for variation of a traditional herbal registration is—

(a) £260, if the application is a standard variation application;

(b) £687, if the application is a complex variation application;

(c) £7,767, if the application is a new excipient variation application; and

(d) £164, if the application is an administrative variation application.

Identical variations

46.—(1) Unless paragraph 47 or 48 applies, where more than one application—

(a) of a type referred to in sub-paragraph (2) is made at the same time by the same marketing authorization holder and all of the applications are for identical kinds of variations; or

(b) by the same applicant is made at the same time for a traditional herbal registration, a manufacturer's licence, or a wholesale dealer's licence and where the applications are for identical variations,

the fee payable under regulation 18(1) is that specified in sub-paragraph (3).

(2) The type of application referred to in sub-paragraph (1) is a—

(a) Type IB Application;

(b) Type II Application;

(c) Minor Variation (Type IB) Group Application; or

(d) Major Variation (Type II) Group Application.

(3) The fee referred to in sub-paragraph (1)—

(a) in connection with the first application considered by the licensing authority is the appropriate amount specified in this Part of this Schedule; and

(b) in connection with each of the other applications is 50% of that amount.

Complex Variation Applications

47.—(1) Where more than one application of a type referred to in sub-paragraph (2) is made at the same time by the same marketing authorization holder and all of the applications are for identical kinds of variations, the fee payable under regulation 18(1)—

(a) in connection with the first application considered by the licensing authority is the appropriate amount specified in this Part of the Schedule; and

(b) in connection with each of the other applications in respect of which no further medical, scientific or pharmaceutical assessment is required, is the amount which would be payable if the application was a Type II Application.

(2) The type of application referred to in sub-paragraph (1) is a—

(a) Type II Complex Variation Application;

(b) Extended Type II Complex Variation Application;

(c) Major Variation (Type II) Complex Group Application; or

(d) Major Variation (Type II) Extended Complex Group Application.

Multiple reclassification variation applications

48.  Where more than one reclassification variation application is made at the same time by the same applicant, each relating to medicinal products which have the same active ingredient or combination of ingredients, the fee payable under regulation 18(1)—

(a) if one or more of the applications is an application to which paragraph 37 does not apply—

(i) in connection with the first application to which paragraph 37 does not apply, is the appropriate amount specified in this Part of the Schedule;

(ii) in connection with each other application to which paragraph 37 does not apply, is £832, unless the application is in an eCTD format application, in which case the fee payable is £794; and

(iii) in connection with each other application to which paragraph 37 does apply, is £416, unless the application is in an eCTD format application, in which case the fee payable is £397; and

(b) in any other case—

(i) in connection with the first application, is the appropriate amount specified in this Part of the Schedule; and

(ii) in connection with each other application, is £416, unless the application is in an eCTD format application, in which case the fee payable is £397.

PART 5 Capital Fees for Assessment of Labels and Leaflets

A set of changes

49.—(1) Unless paragraph 50 applies, the fee payable under regulation 22(1) in connection with a set of proposed changes to the labelling or the package leaflet of a medicinal product is—

(a) £559, in respect of a product which is the subject of a United Kingdom marketing authorization (other than a parallel import licence); and

(b) £354, in respect of a product which is the subject of a parallel import licence.

(2) If the proposed changes in respect of a product to which the fee in sub-paragraph (1)(a) applies are submitted in accordance with the National Guidance on labels and leaflets self-certification, the fee payable under regulation 22(1) is £201.

(3) For the purpose of this paragraph—

(a) changes are submitted in accordance with the National Guidance on labels and leaflets self-certification if they are of a type described in the National Guidance on labelling and patient information leaflets for self-certification and comply with the conditions set out in relation to those changes in that Guidance; and

(b) the “National Guidance on labelling and patient information leaflets for self-certification” means the documents entitled “Guidance on changes to labelling and patient information for self-certification” and “Guidance on changes to labelling for self certification – compliance with article 56(a) – inclusion of Braille on the labelling” published by the licensing authority and available on its website on 9th November 2009 M7 .

Marginal Citations

M7 Copies of the documents can be downloaded from the licensing authority's website at www.mhra.gov.uk or obtained by writing to the licensing authority at Market Towers, 1, Nine Elms Lane, London, SW8 5NQ or by sending an email to [e-mail].

More than one set of charges proposed

50.—(1) In this paragraph, “ clinical particulars” means the clinical particulars contained in the Summary of Product Characteristics for that product as specified in paragraph 4 of Article 11 of the 2001 Directive.

(2) This paragraph applies where more than one set of proposed changes falling within regulation 22(1) is submitted by the same marketing authorization holder at the same time and where—

(a) the sets of proposed changes consist of identical changes to the labelling or package leaflets of products with the same active ingredient or combination of ingredients, dosage form and clinical particulars; or

(b) the sets of proposed changes consist of identical changes to different versions of the labelling or package leaflet of the same product.

(3) Where this paragraph applies, the fee payable under regulation 22(1) is—

(a) in connection with the first set of proposed changes considered by the licensing authority, the appropriate amount specified in paragraph 49; and

(b) in connection with each of the other sets of proposed changes, 50% of that amount.

PART 6 Capital Fees for Regulatory Assistance Given by the United Kingdom Acting as Reference Member State Relating to the Assessment of Applications for the Renewal of Specified Marketing Authorizations

Regulatory assistance

51.  Unless paragraph 52 applies, the fee payable under regulation 26(1) in connection with regulatory assistance provided by the United Kingdom acting as reference Member State where an application is made to the licensing authority for the renewal of a United Kingdom marketing authorization in relation to a medicinal product which has been subject to the procedures specified in regulation 26(2), is—

(a) £10,465, if the application for renewal relates to a medicinal product which, at the time the United Kingdom marketing authorization was granted, contained a new active ingredient and that renewal is the first renewal in relation to which the United Kingdom is to provide regulatory assistance acting as reference Member State; or

(b) £807, in any other case.

Regulatory assistance – same manufacturer

52.—(1) This paragraph applies if more than one application falling within regulation 26(1) is made by the same applicant at the same time, each of which relates to medicinal products which have the same active ingredient or combination of ingredients, dosage form, therapeutic indications and Periodic Safety Update Reports, and the United Kingdom marketing authorizations for those products have the same date for renewal.

(2) The fee payable under regulation 26(1) for applications to which sub-paragraph (1) applies is—

(a) if the applications fall within paragraph 51(a)—

(i) £10,465 for the first application considered by the licensing authority; and

(ii) £807 for each other application;

(b) if the applications fall within paragraph 51(b)—

(i) £807 for the first application considered by the licensing authority; and

(ii) £405 for each other application.

Regulations 27(1), 30,31(2), 32(1)

SCHEDULE 2 FEES FOR INSPECTIONS

General provisions relating to fees for inspections

1.—(1) In this Schedule, a reference to 1 day means a period of 7 hours.

(2) For the purposes of paragraphs 3(2)(c), 4(2)(c), 6(2)(c) and 8, in calculating the number of days taken to make an inspection, any part day shall be calculated as a whole day.

(3) Where an inspection is made at a site which is outside the United Kingdom, the fee for the inspection shall be increased by an amount equal to the travelling and subsistence costs of the inspector relating to the inspection and any additional costs (such as interpreters' fees) reasonably incurred by the inspector in respect of that inspection as a result of its being at a site outside the United Kingdom.

(4) If an inspection is made by more than one inspector, the time taken by the licensing authority to make an inspection is the aggregate of times spent by each inspector in making the inspection.

Fees: general

2.—(1) The fee for an inspection made at a site is—

(a) £2,583, if the time taken to make the inspection is not more than 7 hours; and

(b) thereafter, £1,292 for every additional period of 3 hours and 30 minutes or less taken to make the inspection.

(2) Sub-paragraph (1) does not apply if the inspection is one for which a fee is payable under paragraphs 3 to 7.

Traditional herbal medicinal products

3.—(1) Sub–paragraph (2) applies if the site inspected is wholly concerned with the manufacture, assembly or import from a third country of traditional herbal medicinal products.

(2) If this sub-paragraph applies, the fee payable in respect of an inspection of a site in connection with the grant, variation or renewal of a manufacturer's licence or during the currency of such a licence, is—

(a) £967, if the time taken to make the inspection is not more than 3 hours;

(b) £1,571, if the time taken to make the inspection is more than 3 hours but not more than 1 day; and

(c) if the time taken to make the inspection is more than 1 day, the amount calculated by multiplying the total number of days taken to make the inspection by £1,571.

Sites concerned with starting materials for traditional herbal medicinal products

4.—(1) Sub-paragraph (2) applies if the site inspected is wholly concerned with the manufacture or assembly of starting material for use in the manufacture of traditional herbal medicinal products.

(2) If this sub-paragraph applies, the fee payable in respect of an inspection of an API manufacturer pursuant to Article 111(1)(a) of the 2001 Directive, is—

(a) £967, if the time taken to make the inspection is not more than 3 hours;

(b) £1,571, if the time taken to make the inspection is more than 3 hours but not more than 1 day; and

(c) if the time taken to make the inspection is more than 1 day, the amount calculated by multiplying the total number of days to make the inspection by £1,571.

Wholesale dealer's licence: general

5.  Except in the case of an inspection falling within paragraphs 6 or 7, the fee for an inspection of a site made in connection with the grant, variation or renewal of a wholesale dealer's licence or during the currency of such a licence, is—

(a) if the time taken to make the inspection is not more than 1 day, £1,882; and

(b) if the time taken is 1 day or more, £1,882 for the first day and £941 for every subsequent period of 3 hours and 30 minutes or less taken to make the inspection.

Wholesale dealer's licence: traditional herbal medicinal products

6.—(1) Sub–paragraph (2) applies if the site inspected is wholly concerned with the wholesale dealing of traditional herbal medicinal products.

(2) If this sub-paragraph applies, the fee payable in respect of an inspection of a site in connection with the grant, variation or renewal of a wholesale dealer's licence or during the currency of such a licence is—

(a) £724, if the time taken to make the inspection is not more than 3 hours;

(b) £1,330, if the time taken to make the inspection is more than 3 hours but not more than 1 day; and

(c) if the time taken to make the inspection is more than 1 day, the amount calculated by multiplying the total number of days taken to make the inspection by £1,330.

Wholesale dealer's licences: inspection of short duration

7.—(1) Sub-paragraph (4) applies if the time taken to make the inspection is not more than 3 hours and 30 minutes, and

(a) the site is that of a wholesale dealer whose licence is limited to dealing only in medicinal products falling within a description or class specified in an Order made under section 51(1) (general sale lists) of the Act;

(b) the site relates to a registered pharmacy as referred to in paragraph 31(3) of Part 2 of Schedule 1; or

(c) the total turnover in respect of sales by way of wholesale dealing in authorised medicinal products of the wholesale dealer does not exceed £35,000.

(2) In paragraph (c) of sub–paragraph (1), “turnover” means the gross amount of the total sales made during the period of 12 months preceding the date of the application.

(3) If paragraph (c) of sub-paragraph (1) applies because the applicant has not held a wholesale dealer's licence during the 12 month period preceding the date of the application, sub–paragraph (1) does not apply unless at the time of making the application—

(a) it is reasonable for the applicant to believe that the gross amount of total sales of authorised medicinal products likely to be made in the period of 12 months following the grant of the licence will not exceed £35,000; and

(b) the applicant so informs the licensing authority.

(4) If this sub-paragraph applies, the fee payable in respect of an inspection of a site made in connection with the grant, variation or renewal of a wholesale dealer's licence is £941.

Office-based inspections

8.  The fee for an inspection comprising an office-based evaluation and risk assessment of documentation but not involving inspection of a site, in connection with the monitoring of—

(a) good manufacturing practice, good clinical practice or good pharmacovigilance practice, is £1,812 per day;

(b) good distribution practice, is £1,317 per day.

Regulation 33(2) and (3), 34(2)

SCHEDULE 3 PERIODIC FEES FOR LICENCES

PART 1 Interpretation

1.  In this Schedule—

“anthroposophic product” means a medicinal product prepared in accordance with the methods of anthroposophic medicine which is sold or supplied as an anthroposophic product and is so described by the person who sells or supplies that medicinal product;

“derivative”, in relation to a limited use drug or a new active substance, means a medicinal product—

(a)

which contains the same active ingredient or combination of active ingredients as that drug or substance but which is either—

(i)

a different dosage form of that drug or substance; or

(ii)

of the same dosage form as, but of a different strength of active ingredient to, or of a different combination of active ingredients to, that drug or substance; and

(b)

in respect of which an application for a marketing authorization was made before the determination of the application for the marketing authorization for that drug or substance;

“general sale list medicine” means a medicinal product (not being an anthroposophic product, a herbal remedy or a homoeopathic medicinal product) of a description or falling within a class specified in an Order made under section 51(1) (general sale lists) of the Act;

“limited use drug” means a medicinal product in respect of which an application for a marketing authorization has been submitted, to which point 6 of Part II of Annex I to the 2001 Directive applies or which is in respect of an orphan medicinal product;

“maintenance fee” means the periodic fee payable where the authorization holder has notified the licensing authority that the medicinal product to which the marketing authorization relates, being a prescription only medicine, a pharmacy medicine or a general sale list medicine, is not expected to be manufactured, or imported into the United Kingdom during the relevant fee period; and

(a)

that the medicinal product has not been manufactured or imported into the United Kingdom during the period of 12 months preceding the commencement of the relevant fee period; or

(b)

where the medicinal product had been manufactured or imported into the United Kingdom during the period referred to in (a) above, that turnover did not exceed £1,000 during that period;

“new active substance” means a medicinal product which is not a limited use drug and which contains an active ingredient which has not previously been included as an active ingredient in a medicinal product in respect of which a marketing authorization (other than a product licence of right) has been granted in the five years preceding 31st December in the fee period preceding the relevant fee period;

“pharmacy medicine” means a medicinal product (not being an anthroposophic product, a herbal remedy or a homoeopathic medicinal product) which is neither a prescription only medicine nor a general sale list medicine;

“prescription only medicine” means a medicinal product (not being an anthroposophic product, a herbal remedy, a homoeopathic product, a new active substance or a derivative of a new active substance) of a description or falling within a class specified in an Order made under section 58(1) (medicinal products on prescription only) of the Act;

“reduced rate fee” means the periodic fee payable where the turnover relating to a medicinal product being a prescription only medicine, a pharmacy medicine or a general sale list medicine, does not exceed £35,000 in the relevant calendar year;

“standard fee” means the periodic fee payable where the turnover relating to a medicinal product, being a prescription only medicine, a pharmacy medicine or a general sale list medicine, does exceed £35,000 in the relevant calendar year; and

“turnover” means the amount calculated in accordance with Part 2 of this Schedule.

PART 2 Calculation of Turnover

Calculation of turnover

2.—(1) Subject to sub-paragraph (2), “ turnover” means, for the purposes of calculating the periodic fee payable in connection with the holding of a marketing authorization for a relevant fee period, the gross value at manufacturer's prices of all medicinal products to which the authorization relates which are sold or supplied in the United Kingdom by the holder of the authorization during the period of 12 months preceding the commencement of the relevant fee period.

(2) For the purposes of calculating the periodic fee payable in connection with the holding of marketing authorizations mentioned in Part 4 of this Schedule for a relevant fee period, the quantity of products taken for the purposes of sub-paragraph (1) is the aggregate of all the products to which the authorizations relate.

Manufacturer's prices

3.  For the purposes of paragraph 2, manufacturer's prices are the following—

(a) for products sold or supplied by the authorization holder to wholesalers or to distributors or assemblers named in the marketing authorization, which that holder has manufactured or obtained from the manufacturer, the prices charged for the supply;

(b) for products sold or supplied by the authorization holder to retailers, which that holder has manufactured or obtained from the manufacturer, the prices so charged for the supply less an amount which, in the opinion of the licensing authority, represents the difference between those prices and the prices which would have been charged, in accordance with the practice prevailing during the relevant year, by a wholesaler for the product; or

(c) for products sold or supplied by the authorization holder which that holder has neither manufactured nor obtained from the manufacturer, the price which he paid for the supply.

Evidence of turnover

4.—(1) For the purpose of satisfying the licensing authority for the purposes of Part 3 of this Schedule, an applicant shall, if requested, state the amount of the turnover, calculated in accordance with paragraphs 2 and 3.

(2) Where the authorization holder fails to furnish evidence of the amount of annual turnover to the satisfaction of the licensing authority, the licensing authority may require the authorization holder to furnish an auditor's certificate containing such evidence.

(3) If within one month of the date by which such certificate is required to be furnished, or such longer period as the licensing authority may allow, the authorization holder has failed to furnish such certificate, the sum payable by way of periodic fees for the relevant fee period in question shall be equal to the fee provided for in paragraphs 10 and 13 of Part 3 of this Schedule or shall be such lesser sum as the licensing authority may specify in a written notice served on the authorization holder.

PART 3 Periodic Fees for Marketing Authorizations and Licences

Marketing authorizations

5.  Unless paragraphs 6 to 10 apply, the fee payable under regulation 33(3) in connection with the holding of a marketing authorization relating to a medicinal product of a kind described in column 1 of the following table is the applicable fee specified in the corresponding entry in column 2 of that table.

Periodic fees for holding marketing authorization

Column 1 Kind of product				Column 2 Fee payable
1. New Active Substance				£23,025
2. Other kinds of Medicinal Product—
	(a)	Any product (not being a derivative of a new active substance) in respect of which a marketing authorization has been granted in consequence of a complex application submitted on or after 1st April 1989		£9,481
	(b)	Prescription Only Medicine
		(i)	Standard Fee	£2,371
		(ii)	Reduced Rate Fee	£1,183
		(iii)	Maintenance Fee	£384
	(c)	Pharmacy Medicine
		(i)	Standard Fee	£1,038
		(ii)	Reduced Rate Fee	£519
		(iii)	Maintenance Fee	£192
	(d)	General Sale List Medicine
		(i)	Standard Fee	£429
		(ii)	Reduced Rate Fee	£213
		(iii)	Maintenance Fee	£93
	(e)	Herbal Remedy		£113
	(f)	National homoeopathic product		£81
	(g)	Homoeopathic or anthroposophic product which is the subject of a licence of right		£74

Marketing authorization: where Part 2 of the Act applies

6.  In the case of an article or substance to which Part II of the Act applies by virtue of the Medicines (Surgical Materials) Order 1971 M8 , the fee payable under regulation 33(3) in connection with the holding of a marketing authorization or licence is—

(a) £527, in the case of a standard fee;

(b) £260, in the case of a reduced rate fee; or

(c) £110, in the case of a maintenance fee.

Marginal Citations

M8 S.I. 1971/1267; Part II of the Act is applied by Article 3 of the Order which has been amended by S.I. 1994/3119, 2004/1031 and 2006/2407.

Marketing authorization: derivatives

7.  Unless paragraph 8 applies, where a marketing authorization is held in respect of a derivative of a new active substance, the fee payable under regulation 33(3) is—

(a) £9,481, where the medicinal product to which the authorization relates has a different route of administration from that of the new active substance; or

(b) £6,400, in any other case.

Number of fee periods

8.—(1) The fee specified in—

(a) paragraph 5 for a new active substance; and

(b) in paragraph 7 for a derivative of a new active substance,

is only payable for the five relevant fee periods following that in which the marketing authorization is granted.

(2) The fee payable in accordance with entry 2(a) of the table set out in paragraph 5 is only payable for the three relevant fee periods following the year beginning 1st April during which the marketing authorization is granted.

(3) Where a marketing authorization is surrendered and at the same time another marketing authorization held by the authorization holder is varied so as to include in that other authorization the provisions of the first authorization, the fee payable—

(a) for the five relevant fee periods following the fee period during which the marketing authorization is granted is the fee specified at entry 1 of the table set out in paragraph 5, where the first authorization relates to a new active substance;

(b) in all other cases, for each fee period mentioned in sub-paragraph (2), is the fee specified at entry 2(a) of that table.

(4) In respect of fee periods following those referred to in sub-paragraphs (1) to (3) of this paragraph, the periodic fees are the appropriate fees for the kind of medicinal product in question specified in entries 2(b), (c) or (d) of the table set out in paragraph 5.

(5) In connection with the holding of a marketing authorization in respect of a limited use drug or a derivative of a limited use drug—

(a) where turnover exceeds £200,000, until the expiry of the five relevant fee periods following the fee period during which the marketing authorization was granted, the periodic fee payable is the fee that would be payable if the drug were, respectively, a new active substance or a derivative of a new active substance;

(b) where turnover does not exceed £200,000 or where a periodic fee has been payable in respect of the limited use drug or derivative of a limited use drug for five relevant fee periods following the fee period during which the marketing authorization was granted, the periodic fee payable is the fee payable in respect of a prescription only medicine in accordance with entry 2(b)(i) of the table set out in paragraph 5.

Authorisation for two or more kinds of medicinal product

9.  Where a marketing authorization relates to any two or more medicinal products of a kind described in entries 2(b), (c) or (d) of column 1 of the table in paragraph 5, the fee payable under regulation 33(3) shall be the lower of the fee specified as corresponding to those entries in column 2 of that table.

Reduced fees

10.  Where a reduced rate fee or a maintenance fee may be payable in respect of any relevant fee period and an authorization holder does not submit evidence of turnover in relation to the relevant calendar year to the satisfaction of the licensing authority, the periodic fee payable shall, where applicable, be the standard fee for each description of medicinal product in respect of which a marketing authorization is held by the authorization holder.

Manufacturer's licences or manufacturing authorisations

11.—(1) Unless sub-paragraph (3) applies, the fee payable under regulation 33(3) in connection with the holding of a manufacturer's licence is £457.

(2) The fee payable under regulation 33(3) in connection with the holding of a manufacturing authorisation is £457.

(3) The fee payable under regulation 33(3) in connection with the holding of a manufacturer's licence which relates to the import of exempt imported products from a third country is the fee payable in accordance with sub-paragraph (1) and an additional amount calculated in accordance with paragraph 15.

Wholesale dealer's licences

12.—(1) Subject to sub-paragraph (2) and to paragraphs 13 and 16, the fee payable under regulation 33(3) in connection with the holding of a wholesale dealer's licence is £281.

(2) The fee payable under regulation 33(3) is £168 where the wholesale dealer's licence—

(a) relates to anything done in a registered pharmacy by or under the supervision of a pharmacist and amounts to wholesale dealing, where such dealing constitutes no more than 15% of the total turnover of the sale of authorised medicinal products carried on at that pharmacy;

(b) does not relate to anything done in a registered pharmacy, where the total turnover of the sale by way of wholesale dealing in authorised medicinal products does not exceed £35,000; or

(c) relates to general sale list medicines only.

(3) For the purposes of sub-paragraph (2), the total turnover shall be calculated in accordance with Part 2 of this Schedule and the references to “marketing authorization” and “authorization holder” in Part 2 shall be construed as if they were references to “wholesale dealer's licence” and “licence holder”, respectively.

Wholesale dealer's licences: evidence

13.  Where in respect of any relevant fee period, the holder of a wholesale dealer's licence does not submit evidence of turnover in relation to the relevant calendar year to the satisfaction of the licensing authority, the periodic fee payable shall be the fee prescribed in paragraph 12(1).

Wholesale dealer's licences: exempt imported products

14.  The fee payable under regulation 33(3) in connection with the holding of a wholesale dealer's licence which relates to exempt imported products is the fee payable in accordance with paragraphs 12 and 13 and an additional amount calculated in accordance with paragraph 15.

Additional amount for manufacturer's licences and wholesale dealer's licences which relate to exempt imported products

15.—(1) The additional amount referred to in paragraph 11(3) and 14 in relation to any fee period shall be the fee specified in the entry in column 2 of the following table corresponding to the estimated number of special import notices for that fee period specified in column 1.

Additional periodic fee in connection with exempt imported products

Column 1 Number of special import notices	Column 2 Additional amount
1 to 20	£126
21 to 100	£505
101 to 1,000	£2,020
1,001 to 5,000	£10,100
5,001 to 20,000	£25,250
20,001 to 50,000	£50,500
50,001 to 100,000	£101,000
100,001 or more	£151,500

(2) For the purposes of this paragraph, the estimated number of special import notices for any fee period shall be the number notified in writing to the licence holder by the licensing authority before the start of that fee period as the number of such notices which the authority estimate will be given by the holder during the fee period.

Clinical trial authorisations

16.  The fee payable under regulation 34(2) in connection with the holding of a clinical trial authorisation is £342.

Traditional herbal registrations

17.  The fee payable under regulation 33(3) in connection with the holding of a traditional herbal registration is £96.

PART 4 Types of Marketing Authorization for which only One Periodic Fee is Payable

Specified parallel import licences

18.  In a case where—

(a) parallel import licences in respect of medicinal products for which separate marketing authorizations have been granted pursuant to the provisions of the 2001 Directive in one or more Member States of the European Union; and

(b) those medicinal products have no differences in respect of therapeutic effect from a medicinal product in respect of which a single marketing authorization has previously been granted in the United Kingdom,

only one periodic fee relating to the medicinal product of the kind in question is payable.

Regulation 41(1)

SCHEDULE 4 TIME FOR PAYMENT OF CAPITAL FEES

Interpretation

1.—(1) In this Schedule a reference to an application is to an application made by or on behalf of a small company.

Major application

2.  In connection with a major application for a marketing authorization for which the fee payable is that specified in entry 1(f) of the table in paragraph 24 of Part 2 of Schedule 1, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable as to 25% at the time of the application and as to 75% within 30 days following written notice from the licensing authority that the application has been determined.

Complex application

3.  In connection with a complex application for a marketing authorization, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable—

(a) as to 50% at the time of the application; and

(b) as to 50% within 30 days following written notice from the licensing authority that the application has been determined.

Multiple application

4.  In connection with an application to which paragraph 28 of Part 2 of Schedule 1 applies, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable—

(a) as to 50% of the aggregate payable in accordance with that paragraph at the time of the application; and

(b) as to 50% of that aggregate within 30 days following written notice from the licensing authority that the application has been determined.

Outgoing mutual recognition application

5.  As regards the fee payable under regulation 16 in connection with an application—

(a) to which paragraph 34(2) of Part 3 of Schedule 1 applies—

(i) 25% of that fee shall be payable at the time when, in connection with the application or set of applications for regulatory assistance, a request is made pursuant to the second sub-paragraph of Article 28.1 of the 2001 Directive for an assessment report to be prepared or updated; and

(ii) 75% of that fee shall become payable within 30 days following written notice from the licensing authority that the regulatory assistance is at an end;

(b) to which paragraph 34(3), (4) or (5), of Part 3 of Schedule 1 applies—

(i) 50% of that fee shall be payable at the time when, in connection with the application or set of applications for regulatory assistance, a request is made pursuant to the second sub-paragraph of Article 28.1 of the 2001 Directive for an assessment report to be prepared or updated, and

(ii) 50% of that fee shall become payable within 30 days following written notice from the licensing authority that the regulatory assistance is at an end,

if the applicant so requests in writing.

Application for traditional herbal registration

6.  In connection with an application for a traditional herbal registration, the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable as to 50% at the time of the application and as to 50% within 12 months after that time.

Traditional herbal registration: complex variation

7.  In connection with a complex variation application or a new excipient variation application to vary a traditional herbal registration, the fee payable under regulation 18(1) shall, if the applicant so requests in writing, be payable as to 50% at the time of the application and as to 50% within 12 months after that time.

Application for manufacturer's licence, manufacturing authorisation or wholesale dealer's licence

8.  In connection with an application for a manufacturer's licence, manufacturing authorisation or a wholesale dealer's licence the fee payable under regulation 12(1)(a) shall, if the applicant so requests in writing, be payable as to 50% at the time of the application and as to 50% within 12 months after that time.

Inspection fees in connection with applications

9.  In connection with an application for a marketing authorization, traditional herbal registration, manufacturer's licence or manufacturing authorisation, the fee payable in respect of an inspection at any site other than one named as a possible site for manufacture of a medicinal product by three or more applicants shall, if the applicant so requests in writing, be payable as to 50% within the period of 14 days referred to in regulation 40(1)(b) and as to 50% within 12 months after that date.

Regulation 47(2)

SCHEDULE 5 WAIVER, REDUCTION OR REFUND OF CAPITAL FEES

Interruptions of manufacture, assembly, sale or supply

1.  Where the manufacture, assembly, sale or supply of medicinal products of a particular class or description will be, or is likely to be, interrupted for a period and in consequence thereof the health of the community will be, or is likely to be, put at risk, any capital fees payable under these Regulations in connection with an application for the grant of a marketing authorization or a manufacturer's licence relating to a medicinal product falling within that class or description and made during that period or, if the period will, or is likely to, exceed 3 months of that period, shall be waived.

Reclassification

2.—(1) Where—

(a) an application for a marketing authorization includes a reclassification element within the meaning of paragraph 25 of Part 2 of Schedule 1; and

(b) the licensing authority is satisfied that the reclassification element does not require consideration by a committee established under section 4 (establishment of committees) of the Act M9 or by the Commission established under section 2A (establishment of the Commission on Human Medicines) of the Act M10 ,

50% of the additional amount payable under paragraph 25(1)(a) or (b) or 28(4)(a) of Part 2 of that Schedule shall be refunded, or if it has not yet been paid, shall be waived.

(2) Where—

(a) an application for variation of a marketing authorization is a reclassification variation application (not being an application falling within paragraph 37 of Part 4 of Schedule 1); and

(b) the licensing authority is satisfied that the application does not require consideration by a committee established under section 4 (establishment of committees) of the Act or by the Commission established under section 2A (establishment of the Commission on Human Medicines) of the Act,

50% of the fee payable under paragraph 35 of Schedule 1 and entry 1(c)(i) of Table 1 referred to in that paragraph or of the fee payable under paragraph 48(a)(i) of Part 4 of Schedule 1 shall be refunded, or if it has not yet been paid, shall be waived.

(3) Where—

(a) an application for variation of a parallel import licence falls within paragraph 39(1)(a) of Part 4 of Schedule 1; and

(b) the licensing authority is satisfied that the application does not require consideration by a committee established under section 4 (establishment of committees) of the Act or by the Commission established under section 2A (establishment of the Commission on Human Medicines) of the Act,

50% of the fee payable under that paragraph shall be refunded, or if it has not yet been paid, shall be waived.

(4) For the purposes of sub-paragraphs (1) to (3), a reclassification element or, as the case may be, a variation application does not require consideration by a committee established under section 4 (establishment of committees) of the Act or by the Commission established under section 2A (establishment of the Commission on Human Medicines) of the Act where—

(a) the licensing authority is satisfied that the application does not require consideration by such a committee or the Commission; and

(b) the committee or the Commission are consulted only by virtue of, or in accordance with, paragraph 5 of Schedule 2 to the Marketing Authorisation Regulations (procedural provisions relating to the grant, renewal, variation, revocation and suspension of United Kingdom marketing authorizations).

Marginal Citations

M9 Amendments and substitutions to section 4 have been made by S.I. 2004/1031, 2005/1094 and 2754 and 2006/2407.

M10 Section 2A was inserted by S.I. 2005/1094.

Variation of a traditional herbal registration

3.  Where at the specific written request of the licensing authority, or in response to the imposition of an urgent safety restriction under regulation 8 of the Herbal Regulations, an application is made for the variation of a traditional herbal registration so as to—

(a) restrict any one or more of the indications, dosage or target population; or

(b) add a new contraindication or a warning or both of these,

as a consequence of new information having a bearing on the safe use of the product, the fee payable under regulation 18(1) shall be refunded or, if it has not yet been paid, shall be waived.

Withdrawal of application in relation to marketing authorization, traditional herbal registration or clinical trial authorisation

4.—(1) Subject to sub-paragraph (2), where an application for the grant of, or for a variation to, a marketing authorization or traditional herbal registration, or, an application for a clinical trial authorisation or a notice of amendment to a clinical trial authorisation is withdrawn before determination by the licensing authority, the following percentage of the fee otherwise payable under regulations 12(1)(a), 18(1) or 19(1) in connection with that application or notice shall be refunded or, if it has not yet been paid, shall be waived—

(a) if the application or notice has been received but no medical, scientific or pharmaceutical assessment thereof has begun, 90%;

(b) except in a case to which sub-paragraph (c) applies, if medical, scientific or pharmaceutical assessment has begun but not been completed, 50%;

(c) if a request for further information in connection with the application has been made by the licensing authority under section 44(1) (provision of information to licensing authority) of the Act M11 or in pursuance of a European Union provision which applies to applications for marketing authorizations or traditional herbal registrations, 25%.

(2) If an application for the grant of, or for a variation to, a marketing authorization or traditional herbal registration, or an application for a clinical trial authorisation or a notice of amendment to a clinical trial authorisation, is withdrawn either after medical, scientific and pharmaceutical assessment has been completed or following consideration of that application by a committee established under section 4 (establishment of committees) of the Act or by the Commission established under section 2A (establishment of the Commission on Human Medicines) of the Act, no refund or waiver of the fee payable under regulation 12(1)(a), 18(1) or 19(1) in connection with that application or notice shall be made under this paragraph.

Marginal Citations

M11 Amendments to section 44 have been made by S.I. 2005/1094 and 2006/2407.

Withdrawal of application in relation to manufacturing authorisation, wholesale dealer's licence or manufacturer's licence

5.  Where an application for the grant of, or for a variation to, a manufacturing authorisation, a manufacturer's licence or a wholesale dealer's licence is withdrawn before determination by the licensing authority, the following percentage of the fee otherwise payable under regulation 12(1)(a) or 18(1) in connection with that application shall be refunded or, if it has not yet been paid, shall be waived—

(a) if the application is withdrawn before any inspection in connection with that application has been made, 90%; or

(b) if such an inspection has been made, 50%.

Refusal of application for grant of marketing authorization, traditional herbal registration or clinical trial authorisation

6.  Where an application for the grant of a marketing authorization or traditional herbal registration, or an application for a clinical trial authorisation is refused by the licensing authority and—

(a) the information contained in it, or submitted with it, was not sufficient to enable a full medical, scientific or pharmaceutical assessment to be undertaken; and

(b) if the applicant had withdrawn it before it was refused, part of the fee payable in respect of it would have been refunded or waived under paragraph 3,

there shall be refunded or waived the amount which would have been refunded or waived if the application had been withdrawn before it was refused by the licensing authority.

Parallel import licence

7.  The fee payable for an application to vary a parallel import licence shall be waived if the application is made only—

(a) because of a change to the number of an authorization granted pursuant to the provisions of the 2001 Directive by another Member State for a product to which the licence relates; and

(b) so that the number of that authorization shown on the licence can be changed.

Surrender of marketing authorization at same time as a variation application

8.—(1) Subject to sub-paragraphs (2) and (3), where an applicant applies to vary a marketing authorization in the circumstances set out in paragraph 8(3) of Part 3 of Schedule 3, the fee payable under regulation 18(1) shall be refunded or waived.

(2) Subject to sub-paragraph (3), where an applicant on the same occasion submits more than one such application which relates to medicinal products containing the same active ingredients but no other active ingredient, sub-paragraph (1) shall apply only to one of those applications.

(3) Where in respect of any two or more of the applications mentioned in sub-paragraph (2) provision is made for fees of different amounts by paragraphs 46 and 47 of Part 4 of Schedule 1, sub-paragraph (1) shall apply to the application in respect of which of those paragraphs make provision for the higher or highest fee.

Clinical trial authorisation

9.—(1) In relation to an application for a clinical trial authorisation in relation to a Phase I trial or a Phase II or Phase III trial, the fee payable in respect of such an application may be reduced in accordance with the following sub-paragraphs.

(2) Where the licensing authority is satisfied that the investigational medicinal product dossier submitted in accordance with paragraph 11 of Schedule 3 to the Clinical Trials Regulations does not require a full medical, scientific or pharmaceutical assessment, the fee may be reduced by an amount which the authority considers to be the cost of the assessment work which is not required.

(3) The fee payable may not be reduced below £100.

(4) Where the fee has been reduced by the licensing authority but the applicant has paid the full fee, the amount by which the fee has been reduced shall be refunded to the applicant.

(5) In this paragraph, “Phase I trial” and “Phase II or Phase III trial” have the same meaning as in paragraph 1 of Schedule 1.

Scientific advice: paediatric indications

10.—(1) Where the licensing authority holds a meeting referred to in regulation 4 in order to provide scientific advice with a view to a person making an application other than a major application or an application for a paediatric use marketing authorisation the fee shall be waived if—

(a) sub-paragraphs (2) or (3) apply to the application; and

(b) the meeting is held solely for the purpose of providing advice in relation to the application.

(2) This sub-paragraph applies to the application if—

(a) the application relates to a medicinal product which is intended to be used in accordance with an authorisation for a paediatric indication; and

(b) no other product which has the same active ingredient and is intended to be used in accordance with the same indication and for the same part of the paediatric population as the product in question has previously been granted a marketing authorization.

(3) This sub-paragraph applies to the application if—

(a) the application relates to a medicinal product which is intended to be used in accordance with an authorisation for a paediatric indication;

(b) as a result of the application the medicinal product will be available in a formulation which the licensing authority considers to be of significant benefit to that population in comparison to other medicinal products on the market in the United Kingdom; and

(c) no other product which has the same active ingredient and is in the same formulation as proposed for the product in question has previously been granted a marketing authorization.

(4) In this paragraph—

(a) a medicinal product is authorised for a paediatric indication if it is authorised for use in part or all of that part of the population aged between birth and 18 years and the details of the authorised indication are specified in the summary of characteristics drawn up in accordance with Article 11 of the 2001 Directive M12 ;

(b) “paediatric use marketing authorization” means a marketing authorization granted in respect of a medicinal product for human use which is not protected by a supplementary protection certificate or by a patent which qualifies for the granting of such a certificate, covering exclusively therapeutic indications which are relevant for use in the paediatric population, or subsets thereof, including the appropriate strength, pharmaceutical form or route of administration for that product; and

(c) “supplementary protection certificate” means a certificate granted under Council Regulation (EEC) No. 1768/92 concerning the creation of a supplementary protection certificate for medicinal products M13 and a patent qualifies for the granting of such a certificate if the provisions of that Regulation so provide.

Marginal Citations

M12 Article 11 has been amended by Directive 2004/27/EC (OJ L 136, 30.4.2004, p.34).

M13 OJ L 182, 2.7.1992, p.1, which has been amended by Regulation (EC) No. 1901/2006 (OJ L 378, 27.12.2006, p.1).

Regulation 47(2)

SCHEDULE 6 ADJUSTMENT, REDUCTION OR REFUND OF PERIODIC FEES

Refund on surrender or revocation of authorization, registration or licence

1.  Where, after payment of a periodic fee payable in accordance with the provisions of these Regulations, the marketing authorization, traditional herbal registration or licence in respect of which such a fee has been paid is either—

(a) surrendered at the specific written invitation of the licensing authority; or

(b) revoked by the licensing authority on a date earlier than the date of expiry stated in the marketing authorization, traditional herbal registration, or licence,

the licensing authority shall refund to the applicant the whole or any part of the difference between such periodic fee as has been paid and the amount of the periodic fee payable on the basis of the actual duration of the marketing authorization, traditional herbal registration or licence up to the date of such surrender or revocation.

Adjustment and refund: licences relating to exempt imported products

2.—(1) This paragraph applies to periodic fees payable in connection with a manufacturer's licence or a wholesale dealer's licence which relates to exempt imported products.

(2) If during a fee period the number of special import notices given by a licence holder is greater than the estimated number notified by the licensing authority in accordance with paragraph 15 of Part 3 of Schedule 3, the periodic fee payable in relation to that period shall be increased by the difference, if any, between the amount payable in accordance with that paragraph and the amount which would have been payable if the estimated number notified by the licensing authority for that fee period had been the same as the actual number of notices given during that year.

(3) If during a fee period the number of special import notices given by a licence holder is less than the estimated number notified by the licensing authority in accordance with paragraph 15 of Part 3 of Schedule 3, the licensing authority shall refund the difference, if any, between the amount payable in accordance with that paragraph and the amount which would have been payable if the estimated number notified by the licensing authority for that fee period had been the same as the actual number of notices given during that year.

Refunds: treated as having been paid on account

3.  Any sums payable to the applicant by way of refund of any fees under the provisions of this Schedule may be treated as having been paid on account of any other fee which the applicant is liable to pay (whether by instalments or otherwise) under the provisions of these Regulations.

Regulation 2

SCHEDULE 7 INTERPRETATION

Interpretation

1.  In these Regulations, unless the context requires otherwise—

“the Act” means the Medicines Act 1968 and, except as provided below, expressions used in these Regulations have the same meaning as in the Act;

“the 2001 Directive” means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use M14 ;

“Directive 2003/94/EC” means Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use M15 ;

“Directive 75/319/EEC” means Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products M16 ;

“Council Regulation (EEC) No. 2309/93” means Council Regulation (EEC) No. 2309/93 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products M17 ;

“EC Regulation No. 1234/2008” means Commission Regulation (EC) No. 1234/2008 concerning the examination of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicinal products M18 ;

“Regulation (EC) No. 726/2004” means Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency M19 ;

“active ingredient” has the meaning given in paragraph 1 of Schedule 1;

“API manufacturer” means a person, other than the holder of a manufacturer's licence, engaged in the manufacture or assembly of active substances used as starting materials in the manufacture of medicinal products;

“application”, in relation to a clinical trial authorisation, means a request for authorisation to conduct a clinical trial made in accordance with regulation 17 (request for authorisation to conduct a clinical trial) of the Clinical Trials Regulations, and “applicant”, in relation to such authorisation, means the person making the request;

“authorised medicinal product” means a medicinal product in respect of which a marketing authorization has been granted;

“blood product” means any medicinal product derived from human blood or human plasma and includes albumin, coagulating factor and immunoglobulin of human origin;

“capital fee” means any fee, other than a periodic fee, payable under the provisions of these Regulations;

“change of ownership application” means an application—

(a)

for—

(i)

a marketing authorization for a medicinal product in respect of which another person holds a marketing authorization;

(ii)

a manufacturing authorisation for activities in respect of which another person holds a manufacturing authorisation;

(iii)

a traditional herbal registration for a medicinal product in respect of which another person holds a traditional herbal registration;

(iv)

a manufacturer's licence for activities in respect of which another person holds a manufacturer's licence; or

(v)

a wholesale dealer's licence for activities in respect of which another person holds a wholesale dealer's licence;

(b)

which refers to particulars which are in all material respects identical to the particulars of the marketing authorization, manufacturing authorisation, traditional herbal registration, manufacturer's licence, or wholesale dealer's licence which is held by that other person; and

(c)

which includes a statement to the effect that the other person intends to cease the activities to which the marketing authorization, manufacturing authorisation, traditional herbal registration or licence relates and has consented in writing to the making of the application,

and in this definition particulars do not include particulars relating to the name and address of the applicant, the labelling of any medicinal product or the content of any leaflet relating to such a product;

“clinical development” means the conduct of studies of a medicinal product in human subjects in order to—

(a)

discover or verify the effects of such a product;

(b)

identify any adverse reaction to such a product; or

(c)

study absorption, distribution, metabolism and excretion of such a product,

with the object of ascertaining the safety or efficacy of that product, in accordance with section 5 of Part 1 of Annex I to the 2001 Directive;

“clinical trial” means any investigation in human subjects, other than a non-interventional trial, intended—

(a)

to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products;

(b)

to identify any adverse reactions to one or more such products; or

(c)

to study absorption, distribution, metabolism and excretion of one or more such products,

with the object of ascertaining the safety or efficacy of those products;

“clinical trial authorisation” means authorisation of the conduct of a clinical trial—

(a)

by the licensing authority in accordance with regulation 18 (authorisation procedure for clinical trials involving general medicinal products), 19 (authorisation procedure for clinical trials involving general medicinal products for gene therapy etc.) or 20 (authorisation procedure for clinical trials involving general medicinal products with special characteristics) of the Clinical Trials Regulations; or

(b)

which is treated as having been given by the licensing authority by virtue of Schedule 12 to those Regulations;

“Clinical Trials Regulations” means the Medicines for Human Use (Clinical Trials) Regulations 2004 M20 ;

“complex application” has the meaning given in paragraph 5 of Schedule 1;

“concerned Member State” means for the purpose of—

(a)

regulation 12 and Part 2 of Schedule 1 (capital fees for Applications for Authorizations, Licences, Registrations and Certificates), an EEA State, the competent authorities of which receive an application to obtain recognition, according to the procedure laid down in Title III, Chapter 4 of the 2001 Directive, of a United Kingdom marketing authorization;

(b)

regulation 18 and Part 4 of Schedule 1 (capital fees for applications for variations of authorizations, Licences and Registrations), an EEA State, the competent authority of which has received an application for a variation to the terms of a marketing authorization under the procedure laid down in EC Regulation No. 1234/2008 for a medicinal product in respect of which an authorization was granted by that competent authority, other than the reference Member State;

“contract laboratory” means a laboratory carrying out the examinations and tests referred to in—

(a)

paragraph 5A(2) of Schedule 2 (standard provisions for manufacturer's licences and manufacturer's licences of right) to the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 M21 ; and

(b)

Article 11(1) of Directive 2003/94/EC,

on behalf of the holder of a manufacturing authorisation, manufacturer's licence or wholesale dealer's licence, pursuant to Article 11(2) of that Directive and Article 20(b) of the 2001 Directive;

“European Union marketing authorization” means a marketing authorization granted by the European Commission under Council Regulation (EEC) No. 2309/93 or Regulation (EC) No. 726/2004;

“exempt imported product” means a medicinal product, as defined in Article 1(2) of the 2001 Directive, to which paragraph 1 of Schedule 1 (exemptions and exceptions from the provisions of regulation 3) to the Marketing Authorisation Regulations applies, which was not manufactured in the United Kingdom and in relation to which no marketing authorization has been granted;

“fee period” means the period beginning with the first day of April in any year and ending with the last day of March in the following year;

“good clinical practice” means the conditions and principles of good clinical practice specified in Schedule 1 to the Clinical Trials Regulations;

“good distribution practice” means the Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C63/03) published by the European Commission pursuant to Article 84 of the 2001 Directive;

“good manufacturing practice” means the principles and guidelines of good manufacturing practice set out in Directive 2003/94/EC;

“good pharmacovigilance practice” means the Guidelines on Pharmacovigilance for Medicinal Products for Human Use published by the European Commission pursuant to Article 106 of the 2001 Directive;

“herbal substances” has the meaning given by Article 1(31) of the 2001 Directive;

“Herbal Regulations” means the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 M22 ;

“holder”, in relation to a clinical trial authorisation, means—

(a)

in the case of an authorisation treated as having been given by the licensing authority by virtue of Schedule 12 (transitional provisions) to the Clinical Trials Regulations, the person acting as sponsor of the clinical trial for the purposes of those Regulations; or

(b)

in any other case, the person who made the request for that authorisation;

“homoeopathic medicinal product” means any medicinal product (which may contain a number of principles) prepared from substances called homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by any pharmacopoeia used officially in a Member State;

“Homoeopathic Regulations” means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 M23 ;

“immunological product” means any medicinal product which is a vaccine, toxin, serum or allergen product;

“licensing authority” shall be construed in accordance with section 6 of the Act;

“major application” has the meaning given in paragraph 10 of Schedule 1;

“manufacturer's licence” means a manufacturer's licence falling within the meaning of section 8(2) of the Act which relates wholly or partly to medicinal products for human use;

“manufacturing authorisation” means a manufacturing authorisation granted for the purposes of regulation 36 (requirement for authorisation to manufacture or import investigational medicinal products) of the Clinical Trials Regulations;

“marketing authorization” means, except in regulation 3—

(a)

a United Kingdom marketing authorization granted by the licensing authority under the Marketing Authorisation Regulations;

(b)

a European Union marketing authorization; or

(c)

a product licence, including one which is a licence of right or one which has effect as a marketing authorization by virtue of paragraph 1 of Schedule 6 (transitional provisions) to the Marketing Authorisation Regulations,

which relates to a medicinal product for human use;

“Marketing Authorisation Regulations” means the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994 M24 ;

“medicinal product” includes any medicinal product for human use to which the 2001 Directive applies and any substance or article specified in any order for the time being in force made under section 104 (application of the Act to certain articles and substances) or 105(1)(a) (application of the Act to certain other substances which are not medicinal products) of the Act M25 which directs that Part II of the Act or the Clinical Trials Regulations shall have effect in relation to such substance or article;

“national homoeopathic product” means a homoeopathic medicinal product which—

(a)

does not satisfy the conditions set out in Article 14(1) of the 2001 Directive; and

(b)

is indicated for the relief or treatment of minor symptoms or minor conditions in humans;

“operator”, in relation to a contract laboratory, means the person having control of the contract laboratory;

“orphan medicinal product” has the meaning given in article 2(b) of Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16th December 1999 on orphan medicinal products M26 ;

“parallel import licence” means a United Kingdom marketing authorisation granted by the licensing authority under the Marketing Authorisation Regulations in respect of a relevant medicinal product which is imported into the United Kingdom from another EEA State in accordance with the rules of European Union law relating to parallel imports;

“penalty fee” means a fee payable under regulation 44;

“periodic fee” means the fee payable under regulation 33 or 34 by the holder of—

(a)

a marketing authorization (other than a European Union marketing authorization), a traditional herbal registration, a manufacturing authorisation, a manufacturer's licence, a wholesale dealer's licence; or

(b)

a clinical trial authorisation in respect of the holding of the authorization, registration, authorisation or licence;

“Periodic Safety Update Report” means a report prepared to meet the requirements of the 2001 Directive;

“pharmacovigilance advice” means advice, other than scientific advice, which falls within one or more of the descriptions specified in paragraphs (a) and (b)—

(a)

the advice is in connection with an application for an EU marketing authorization, or is given with a view to a person making such an application, and relates to—

(i)

the obligations that would relate to the holder of such an authorization by virtue of Title IX of the 2001 Directive or Chapter 3 of Title II of Regulation (EC) No. 726/2004;

(ii)

the pharmacovigilance and risk-management systems that the applicant would be required to introduce in accordance with Article 8(3)(ia) of the 2001 Directive; or

(iii)

a post-authorization safety study protocol;

(b)

the advice is given to the holder of a United Kingdom marketing authorization or a European Union marketing authorization and relates to—

(i)

compliance with the obligations that relate to him by virtue of Title IX of the 2001 Directive or Chapter 3 of Title II of Regulation (EC) No. 726/2004;

(ii)

the pharmacovigilance and risk-management systems that he has introduced in accordance with Article 8(3)(ia) of the 2001 Directive; or

(iii)

a post-authorization safety study protocol;

“post-authorization safety study protocol” means a document that describes the objectives, design, methodology, statistical considerations and organisation of a post-authorization safety study;

“product licence” means a product licence falling within the meaning of section 7 of the Act;

“product licence of right” means a product licence within the meaning of section 7 (general provisions as to dealing with medicinal products) of the Act M27 which is a licence of right within the meaning of section 25(4) (entitlement to licence of right) of the Act;

“product range” means one or more medicinal products containing the same active substance in relation to which the same person holds more than one EU marketing authorization;

“quality development” means the chemical, pharmaceutical and biological testing necessary to demonstrate the quality of a relevant medicinal product, in accordance with section 3 of Part 1 of Annex I to the 2001 Directive;

“regulatory advice” means advice, other than scientific advice, in relation to the requirements of the 2001 Directive or Regulation (EC) No. 726/2004 and which falls within one or more of the descriptions specified in sub-paragraphs (a) to (c)—

(a)

the advice is in connection with a change to the dates for renewal of one or more EU marketing authorizations relating to a product range pursuant to Article 24 of the 2001 Directive;

(b)

the advice is in connection with—

(i)

a referral pursuant to Article 30, 31 or 36 of the 2001 Directive; or

(ii)

the procedure referred to in Article 35(2) of the 2001 Directive,

in relation to a product range; or

(c)

the advice is given to a person with a view to that person making—

(i)

an application for the variation or renewal of one or more EU marketing authorizations; or

(ii)

an application to amend the time periods for submitting Periodic Safety Update Reports under Article 104(6) of the 2001 Directive,

in relation to a product range;

“relevant fee period” means any fee period during any part of which a marketing authorization, traditional herbal registration, clinical trial authorisation, manufacturing authorisation or licence in respect of which a periodic fee is payable is in force;

“relevant medicinal product” means a medicinal product for human use to which the provisions of the 2001 Directive apply other than—

(a)

a traditional herbal medicinal product; or

(b)

a homoeopathic medicinal product that fulfils the conditions laid down in Article 14(1) of the 2001 Directive;

“safety development” means the toxicological and pharmacological testing necessary to demonstrate the safety of a relevant medicinal product, in accordance with section 4 of Part 1 of Annex 1 to the 2001 Directive;

“scientific advice” means advice in connection with the quality, safety or clinical development for a relevant medicinal product;

“special import notice” means a written notice given to the licensing authority in accordance with paragraph 7(2) of Schedule 2 (standard provisions which may be incorporated in a manufacturer's licence relating to the import of relevant medicinal products from a third country) to, or paragraph 3(2) of Schedule 4 (standard provisions which may be incorporated in a wholesale dealer's licence) to, the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 M28 ;

“traditional herbal medicinal product” has the meaning given by Article 1(29) of the 2001 Directive;

“traditional herbal registration” means a registration granted by the licensing authority under the Herbal Regulations;

“United Kingdom marketing authorization” means a marketing authorization granted by the licensing authority under the Marketing Authorisation Regulations;

“variation”—

(a)

in relation to—

(i)

a United Kingdom marketing authorization; or

(ii)

a product licence which has effect as such a marketing authorization by virtue of paragraph 1 of Schedule 6 (transitional provisions) to the Marketing Authorisation Regulations,

means “variation to the terms of a marketing authorization” as defined in Article 2(1) of EC Regulation No. 1234/2008;

(b)

in relation to a traditional herbal registration, means a variation of the provisions of a traditional herbal registration;

“wholesale dealer's licence” means a wholesale dealer's licence falling within the meaning of section 8(3) of the Act which relates wholly or partly to medicinal products for human use.

Marginal Citations

M14 OJ No. L 311, 28.11.2001, p.67; relevant amending instruments are Directive 2002/98/EC of the European Parliament and of the Council (OJ No. L 33, 8.2.2003, p.30), Commission Directive 2003/63/EC (OJ No. L 159, 27.6.2003, p.46), Directive 2004/24/EC of the European Parliament and of the Council (OJ No. L 136, 30.4.2004, p.85), Directive 2004/27/EC of the European Parliament and of Council (OJ No. L 136, 30.4.2004, p.34), Regulation (EC) No. 1901/2006 of the European Parliament and of the Council (OJ No. L 378, 27.12.2006, p.1), Regulation (EC) No. 1394/2007 of the European Parliament and of the Council (OJ No. L 324, 10.12.2007, p.121), Directive 2008/29/EC of the European Parliament and of Council (OJ No. L 81, 20.3.2008, p.51), Directive 2009/53/EC of the European Parliament and of Council (OJ No. L 168, 30.6.2009, p.33) and Commission Directive 2009/120/EC (OJ No. L 242, 15.9.2009, p.3).

M15 OJ No. L 262, 14.10.2003, p.22.

M16 OJ No. L 147, 9.6.1975, p.13. This Directive has been codified and assembled with others into Directive 2001/83/EC.

M17 OJ No. L 214, 24.8.1993. This Regulation has been replaced by Regulation (EC) No 726/2004.

M18 OJ No. L 334, 12.12.2008, p.7.

M19 OJ No. L 136, 30.4.2004, p.1; relevant amending instruments are Regulation (EC) No. 1901/2006 of the European Parliament and of the Council (OJ No. L 378, 27.12.2006, p.1), Regulation (EC) No. 1394/2007 of the European Parliament and of the Council (OJ No. L 324, 10.12.2007, p.121), Regulation (EC) No. 219/2009 of the European Parliament and of the Council (OJ No. L 87, 31.3.2009, p.109) and Regulation (EC) No. 470/2009 of the European Parliament and of the Council (OJ No. L 168, 16.6.2009, p.11).

M20 S.I. 2004/1031; relevant amending instruments are S.I. 2004/3224, 2005/2754 and 2759, 2006/562, 1928 and 2984, 2007/289 and 3101, 2008/941 and 2009/1164.

M21 S.I. 1971/972; relevant amending instruments are S.I. 1992/2846, 1994/2852, 2004/1031 and 2005/2789.

M22 S.I. 2005/2750, as amended by S.I. 2006/914.

M23 S.I. 1994/105; relevant amending instruments are S.I. 1994/899, 1996/482, 1998/574, 1999/566, 2001/795, 2002/236 and 254, 2003/625 and 2321, 2005/2753, 2006/2125 and 2407, 2007/803 and 2009/389.

M24 S.I. 1994/3144; relevant amending instruments are S.I. 1996/1499, 1998/3105, 2000/292, 2001/795, 2002/236 and 542, 2003/1618, 2317 and 2321, 2004/856 (as regards England), 1016 (as regards Wales), 1031, 2290 and 3224, 2005/50, 768, 1094, 1520, 1710, 2754 and 2759, 2006/562 (as regards England), 914, 1952 and 2407, 2007/289, 2008/3097 and 2009/1164, 2820, 3063 and 3222.

M25 Amendments have been made to these sections by S.I. 2004/1031 and 2006/2407.

M26 OJ No. L 18, 22.1.2000, p.1, as amended by Regulation (EC) No. 596/2009 of the European Parliament and of the Council (OJ No. L 188, 18.7.2009, p.14).

M27 Repeals and amendments to section 7 have been made by S.I. 1977/1050, 1983/1724, 1992/604, 1994/276, 2004/1031, 2005/50 and 2753 and 2006/2407.

M28 S.I. 2005/2789.

2.  For the purposes of these Regulations, a clinical trial authorisation is in force unless the licensing authority has—

(a) received notification of the conclusion of the clinical trial to which the authorisation relates, in accordance with regulation 27 (conclusion of clinical trial) of the Clinical Trials Regulations; or

(b) suspended or terminated the trial at all sites at which that clinical trial was conducted, in accordance with regulation 31 (suspension or termination of clinical trial) of those Regulations M29 .

Marginal Citations

M29 Revocations and amendments to regulation 31 have been made by S.I. 2005/2754 and 2006/1928.

3.  In these Regulations any reference to an application for the variation of a marketing authorization includes a reference to a notification of such a variation and any reference to an applicant for a variation to a marketing authorization includes a reference to a person who submits such a notification.