The Medicines (Products for Human Use) (Fees) Regulations 2016 No. 190

SCHEDULES

Regulations 12(1)(a); 13; 17;19(2)(a); 20(2)(a); 23(7); 24; 25(1);29(1) and (3)

SCHEDULE 2 U.K. Capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates

PART 1 U.K. General: interpretation and categories of applications and variations

Interpretation U.K.

1.  In this Schedule—

“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 authorisation (other than a product licence of right) or a traditional herbal registration has previously been granted;

“EU marketing authorisation” means—

(a)

a marketing authorisation; or

(b)

an authorisation 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 [F1 and Social Care] 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 authorisation (other than a product licence of right) has previously been granted;

“new excipient” means—

(a)

except in Part 2, paragraph 35 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 authorisation (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 35 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 authorisation (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 authorisation; or

(b)

has an EU marketing authorisation, 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 authorisation;

“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” means 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 authorisation (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 authorisation (other than a product licence of right) or a traditional herbal registration has previously been granted.

Textual Amendments

F1 Words in Sch. 2 para. 1 inserted (11.4.2018) by The Secretaries of State for Health and Social Care and for Housing, Communities and Local Government and Transfer of Functions (Commonhold Land) Order 2018 (S.I. 2018/378), art. 1(2), Sch. para. 20(ff) (with art. 14)

General: categories of Applications and Variations U.K.

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

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

Administrative variation application U.K.

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 U.K.

4.  An extension application is an application—

[F2 (a) for an extension of a marketing authorisation—

(i) in the case of a UKMA(NI) or UKMA(UK), within the meaning of Article 2(4) of Commission Regulation (EC) No 1234/2008; or

(ii) in the case of a UKMA(GB), within the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations; and]

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

Textual Amendments

F2 Sch. 2 para. 4(a) substituted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 7(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(i))

Complex application U.K.

5.  A complex application is an application, other than a major application, for a marketing authorisation 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 authorisation (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 authorisation (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 authorisation (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 authorisation (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 authorisation (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 authorisation (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 authorisation which the applicant holds in respect of that product;

(k) the application is for the grant of a marketing authorisation 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 authorisation which the applicant holds;

(l) the application is for the grant of a marketing authorisation 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 authorisation 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 authorisation (other than a product licence of right) has previously been granted;

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

Complex registration application U.K.

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 authorisation (other than a product licence of right) or a traditional herbal registration has previously been granted.

Complex variation application U.K.

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 U.K.

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

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

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

Extended Type II Complex Variation Application U.K.

9.  An Extended Type II Complex Variation Application is an application by a marketing authorisation holder to vary a marketing authorisation (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 U.K.

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

Mutual recognition procedure incoming application U.K.

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

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

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

New excipient variation application U.K.

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 U.K.

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

Parallel Import Licence application U.K.

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 authorisation (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 authorisation (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 authorisation (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 authorisation (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 authorisation has not been made under 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 authorisation 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 authorisation 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 F3 .

Textual Amendments

F3 2006 c.46.

Reclassification variation application U.K.

15.  A reclassification variation application is an application for variation of a marketing authorisation which has the effect that a medicinal product to which that authorisation 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 U.K.

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 U.K.

17.  A simple application is an application—

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

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

Standard application U.K.

18.  A standard application is any application for the grant of a marketing authorisation 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 U.K.

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 U.K.

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 U.K.

21.  A standard variation application for a homoeopathic medicinal product is an application for a variation of a marketing authorisation 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 authorisation referred to in Article 40 of the 2001 Directive.

Type IB and Type II Applications U.K.

22.—(1) A Type IB Application is an application by a marketing authorisation holder to vary a marketing authorisation (not being a parallel import licence) which is a “minor variation of type IB” within the meaning of

[F4 (a) in the case of a UKMA(NI) or UKMA(UK), Article 2(5) of Commission Regulation (EC) No 1234/2008;

(b) in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations]

(2) A Type II Application is an application by a marketing authorisation holder to vary a marketing authorisation (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 authorisation within the meaning of Article 2(4) of Commission Regulation (EC) No 1234/2008.

[F5 (a) in the case of a UKMA(NI) or UKMA(UK), Article 2(4) of Commission Regulation (EC) No 1234/2008;

(b) in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations]

(3) For the purposes of sub-paragraph (2)(b), a “Type IA Application” means an application by a marketing authorisation holder to vary a marketing authorisation (not being a parallel import licence) which is a “minor variation of type IA” within the meaning of

[F6 (a) in the case of a UKMA(NI) or UKMA(UK), Article 2(2) of Commission Regulation (EC) No 1234/2008;

(b) in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations]

Textual Amendments

F4 Sch. 2 para. 22(1)(a)(b) substituted for words in Sch. 2 para. 22(1) (31.12.2020) by S.I. 2019/775, Sch. 1 para. 7(3)(a) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(ii)(aa))

F5 Sch. 2 para. 22(2)(a)(b)(f) substituted for words in Sch. 2 para. 22(2)(f) (31.12.2020) by S.I. 2019/775, Sch. 1 para. 7(3)(b) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(ii)(bb))

F6 Sch. 2 para. 22(3)(a)(b) substituted for words in Sch. 2 para. 22(3) (31.12.2020) by S.I. 2019/775, Sch. 1 para. 7(3)(c) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(ii)(cc))

Type II Complex Variation Application U.K.

23.  A Type II Complex Variation Application is an application for a variation of a marketing authorisation, 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 [F7 in the case of a UKMA(NI) or UKMA(UK), paragraph 1 (changes to active substances) or paragraph 2 (changes to strength, pharmaceutical form and route of administration) of Annex I to Commission Regulation (EC) No 1234/2008 applies or, in the case of a UKMA(GB), sub-paragraph (a) (changes to active substances) or sub-paragraph (b) (changes to strength, pharmaceutical form and route of administration) of the definition of “extension of a UK marketing authorisation” in paragraph 1 of Schedule 10A to the Human Medicines Regulations 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 [F8 in the case of a UKMA(NI) or UKMA(UK), Article 2(3) of Commission Regulation (EC) No 1234/2008 or, in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations] 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 authorisation 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 [F9 in the case of a UKMA(NI) or UKMA(UK), Commission Regulation (EC) No 1234/2008 or, in the case of a UKMA(GB), paragraph 1 of Schedule 10A to the Human Medicines Regulations] .

Textual Amendments

F7 Words in Sch. 2 para. 23(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(4)(a) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(iii)(aa)); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in Sch. 2 para. 23(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(4)(b) (with Sch. 1 para. 11) (as amended byThe Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(iii)(bb)); 2020 c. 1, Sch. 5 para. 1(1)

F9 Words in Sch. 2 para. 23(c) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(4)(c) (with Sch. 1 para. 11) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(iii)(cc)); 2020 c. 1, Sch. 5 para. 1(1)

PART 2 U.K. Capital Fees for Applications for Authorisations, Licences, Registrations and Certificates

Marketing authorisations U.K.

24.—(1) Unless sub-paragraphs (2) or (4) or paragraphs 25, 26, 28 or 29 apply, the fee payable under regulation 12(1)(a) in connection with an application for a marketing authorisation 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.

(2) This paragraph applies—

(a) to a complex application for a marketing authorisation of a kind described in item 2 in column 1 of the following table; and

(b) where the application only concerns a new source or supply of a substance listed in Part 7 of this Schedule.

(3) If sub-paragraph (2) applies the appropriate fee is the amount specified for an application of the same type under item 3 of the following table.

(4) This paragraph applies—

(a) to a complex application for a parallel import licence of a kind described in item 5(c) in column 1 of the following table; and

(b) where the application only concerns a new source or supply of a relevant substance listed in Part 7 of this Schedule.

(5) If sub-paragraph (4) applies the appropriate fee is the amount specified for item 5(b) in the following table.

[F10 Fees for marketing authorisation applications

Column 1 Kind of application		Column 2 Fee payable
1. Major Application
(a)	in respect of an application relating to an orphan medicinal product to which point 6 of Part II of Annex 1 to the 2001 Directive applies	£29,732
(b)	which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£62,421
(c)	which is a European reference product application in the case of a product for sale or supply in Northern Ireland	£62,421
(d)	which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for UKMA(GB)	£62,421
(e)	in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004	£18,437
(f)	in respect of an application for a UKMA(GB) or UKMA(UK), other than a UKMA(GB) under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by competent authorities of the EEA under Article 28 of the 2001 Directive	£62,421
(g)	in respect of an application for a UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application)	£18,437
(h)	in any other case	£92,753
2. Complex application
(a)	which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£17,330
(b)	which is a European reference product application in the case of a product for sale or supply in Northern Ireland	£17,330
(c)	which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£17,330
(d)	in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004	£10,443
(e)	in respect of an application for a UKMA(GB) or UKMA(UK), other than a UKMA(GB) under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by competent authorities of the EEA under Article 28 of the 2001 Directive	£17,330
(f)	in respect of an application for a UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application)	£10,443
(g)	in any other case	£25,643
3. Standard application
(a)	which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£6,350
(b)	which is a European reference product application in the case of a product for sale or supply in Northern Ireland	£6,350
(c)	which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£6,350
(d)	in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004	£5,783
(e)	in respect of an application for a UKMA(GB) or UKMA(UK), other than a UKMA(GB) under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by competent authorities of the EEA under Article 28 of the 2001 Directive	£6,350
(f)	in respect of an application for a UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application)	£5,783
(g)	in any other case	£9,402
4. Simple application
(a)	which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£2,564
(b)	which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB)	£2,564
(c)	in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004	£2,564
(d)	in respect of an application for a UKMA(GB) or UKMA(UK), other than a UKMA(GB) under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by a competent authority of an EEA State under Article 28 of the 2001 Directive	£2,564
(e)	in respect of an application for a UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application)	£2,564
(f)	in any other case	£2,564
5. Parallel import licence applications
(a)	in respect of a simple parallel import licence	£1,792
(b)	in respect of a standard parallel import licence	£6,663
(c)	in respect of a complex parallel import licence	£18,180
6. Change of ownership application		£442]

(6) 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 this paragraph in respect of an application of the kind in question.

Textual Amendments

F10 Sch. 2 para. 24 Table substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(5) (with Sch. 1 para. 11) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(iv)); 2020 c. 1, Sch. 5 para. 1(1)

[F11 Fees where an application for a European Union marketing authorisation had been made before IP completion day U.K.

24A.— (1) This paragraph applies where, before IP completion day —

(a) an application has been made to the EMA for a European Union marketing authorisation;

(b) day 120 has passed; and

(c) no final decision has been made by the European Commission in relation to the grant of an European Union marketing authorisation under Article 10 of Regulation (EC) No 726/2004.

(2) Where this paragraph applies and the applicant for the European Union marketing authorisation applies for a UK marketing authorisation in accordance with paragraph 31(2) of Schedule 33A to the Human Medicines Regulations, the fee payable under regulation 12(1) shall be waived.

(3) In this paragraph, “day 120” means the day during the assessment of an application for a European Union marketing authorisation on which the Committee for Medicinal Products for Human Use adopts the list of questions, as well as the overall conclusions and review of the scientific data, to be sent to the applicant.]

Textual Amendments

F11 Sch. 2 para. 24A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(6) (with Sch. 1 para. 11) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(v)(aa)(bb); 2020 c. 1, Sch. 5 para. 1(1)

Fees where application includes reclassification U.K.

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 £11,992 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 £8,162 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 authorisation or a European Union marketing authorisation 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 U.K.

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 authorisation 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 U.K.

27.—(1) In this paragraph—

“joint development” means the development by two or more applicants for marketing authorisations 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 the Commission on Human Medicines, the Herbal Medicines Advisory Committee or the Advisory Board on the Registration of Homoeopathic Products;

(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 authorisations 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 authorisation 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 authorisation 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 authorisation 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 authorisations 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—

[F12 (a) in respect of the first or only marketing authorisation applied for by that secondary applicant—

(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £17,330; or

(ii) in any other case, the amount payable in respect of a complex application under paragraph 24;

(b) in respect of each additional marketing authorisation applied for by that secondary applicant which relates to a medicinal product of the same dosage form—

(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,350; or

(ii) in any other case, the amount payable in respect of a standard application under paragraph 24;

(c) in respect of the first additional marketing authorisation applied for by that secondary applicant relating to that medicinal product which is of a different dosage form—

(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £17,330; or

(ii) in any other case, the amount payable in respect of a complex application under paragraph 24;

(d) in respect of any other additional marketing authorisation applied for by that secondary applicant relating to that medicinal product which is of a different dosage form—

(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,350; or

(ii) in any other case, 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 authorisation 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—

[F13 (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 applicant is—

(i) in the case of an application relating to a biological medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,350; or

(ii) in any other case, the amount payable 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.

Textual Amendments

F12 Sch. 2 para. 27(2)(a)-(d) substituted for Sch. 2 para. 27(2)(a)-(c) (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(7)(a) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

F13 Sch. 2 para. 27(3)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(7)(b) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

Application for multiple authorisations U.K.

28.—(1) Unless sub-paragraph (2), (3) or (4) applies, where an application for a marketing authorisation is for more than one such authorisation 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 total of the amounts payable under paragraph 24 in respect of a separate application for each such authorisation.

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

[F14 (a) in respect of each additional marketing authorisation applied for which relates to a medicinal product of a different dosage form with a different route of administration—

(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £17,330; or

(ii) in any other case, the amount payable in respect of a complex application under paragraph 24;

(b) in respect of each additional marketing authorisation applied for which relates to a medicinal product of a different dosage form but with the same route of administration—

(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,350; or

(ii) in any other case, the amount payable in respect of a standard application under paragraph 24; and

(c) in respect of each additional marketing authorisation 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—

(i) in the case of an application relating to a medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,350; or

(ii) in any other case, 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 authorisation 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;

[F15 (b) in respect of each additional marketing authorisation applied for which relates to a medicinal product of a different dosage form but with the same route of administration—

(i) in the case of an application relating to a biological medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,350; or

(ii) in any other case, the amount payable in respect of a standard application under paragraph 24; and

(c) in respect of each additional marketing authorisation 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—

(i) in the case of an application relating to a biological medicinal product that has received an opinion favourable to the granting of a marketing authorisation from the Committee for Medicinal Products for Human Use, £6,350; or

(ii) in any other case, the amount payable in respect of a standard application under paragraph 24.]

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

(a) in respect of the first marketing authorisation 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 authorisation applied for that includes a reclassification element, £734.

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

Textual Amendments

F14 Sch. 2 para. 28(2)(a)-(c) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(8)(a) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

F15 Sch. 2 para. 28(3)(b)(c) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(8)(b) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

[F16 Application by pre-assessment of modules U.K.

28A.— (1) Where an applicant for a United Kingdom marketing authorisation submits material in accordance with regulation 50(5) of the Human Medicines Regulations for pre-assessment by the licensing authority rather than as part of the submission of a full application for that marketing authorisation, the fee payable in respect of pre-assessment of each of the following Modules (as defined in Annex I to the 2001 Directive) is—

(a) £23,188.25 in respect of Module 3 (chemical, pharmaceutical and biological information);

(b) £23,188.25 in respect of Module 4 (non-clinical reports);

(c) £23,188.25 in respect of Module 5 (clinical study reports).

(2) Where an applicant for a United Kingdom marketing authorisation for a similar biological medicinal product submits material in accordance with regulations 53, 53A or 53B of the Human Medicines Regulations for pre-assessment of a complex abridged application by the licensing authority rather than as part of the submission of a full application for that marketing authorisation, the fee payable in respect of pre-assessment of each of the following Modules (as defined in Annex I to the 2001 Directive) is—

(a) £4,332.50 in respect of Module 3 (chemical, pharmaceutical and biological information);

(b) £4,332.50 in respect of Module 4 (non-clinical reports);

(c) £4,332.50 in respect of Module 5 (clinical study reports).

(3) The fee payable under sub-paragraphs (1) and (2) must be paid within a period of 14 days, commencing on the date of the written notice issued by the licensing authority requiring payment of the fee.

(4) Where a fee has been paid under this paragraph, any fee payable under regulation 12(1) in connection with an application for the grant of a United Kingdom marketing authorisation in respect of the same product is reduced by the amount paid under this paragraph provided that no further assessment of the Module concerned is required.]

Textual Amendments

F16 Sch. 2 para. 28A inserted by S.I. 2019/775, Sch. 1 para. 7(8A) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(vi))

Authorisation for a national homoeopathic product U.K.

29.—(1) In this paragraph—

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

“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.

(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 authorisation 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 authorisation 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 authorisation 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			£517	£732
2. An application in respect of a product which is either—			£808	£1,014
	(a)	prepared solely from repeat stocks; or
	(b)	is of a repeat formulation
3. Any other application			£1,088	£1,312

(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 authorisation (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 £2,154 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 £7,185 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 £635 is payable in addition to the amount payable under sub-paragraph (3) or (4) in respect of that application.

Manufacturer's licences and authorisations U.K.

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) £183 in a case to which sub-paragraph (2) applies;

(b) £344 in the case of a change of ownership application; and

(c) £3,143 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 regulation 169 (mixing of general sale medicinal products) of the Human Medicines Regulations applies.

Wholesale dealer's licences U.K.

31.—(1) Unless sub-paragraph (2) or (5) applies, the fee payable under regulation 12(1)(a) in connection with an application for a wholesale dealer's licence is £1,803.

(2) Where this sub-paragraph applies, the fee payable under regulation 12(1)(a) is £902.

(3) Subject to sub-paragraph (4), 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 classified as subject to general sale under regulation 5(1) (classification of medicinal products) or paragraph 3(5) of Schedule 32 (transitional provisions and savings: product licences of right) to the Human Medicines Regulations.

(4) 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.

(5) The fee payable under regulation 12(1)(a) in connection with a change of ownership application is £399.

Broker's registrations U.K.

32.—(1) The fee payable under regulation 12(1)(a) in connection with an application for a broker's registration is £1,803.

(2) The fee payable under regulation 12(1)(a) in connection with a change of ownership application is £399.

Active substance registrations U.K.

33.—(1) The fee payable under regulation 12(1)(a) in connection with an application for an active substance registration is—

(a) £3,143 where the application includes the manufacture of active substances; or

(b) £1,803 where the application only concerns the importation or distribution of active substances.

(2) The fee payable under regulation 12(1)(a) in connection with a change of ownership application is £399.

Clinical trial authorisations U.K.

34.  The fee payable under regulation 12(1)(a) in connection with an application for a clinical trial authorisation is—

(a) £3,060, where the application is for a product that is not marketed; or

(b) £225, where the application is for a product that is marketed.

Traditional herbal registrations U.K.

35.—(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	£4,846
	(b)		in any other case	£7,269
2. Standard registration application
	(a)		in respect of a medicinal product containing 3 or fewer active ingredients	£2,423
	(b)		in any other case	£3,634
3. Reduced registration application category II
		(a)	in respect of a medicinal product containing 3 or fewer active ingredients	£807
		(b)	in any other case	£1,212
4. Reduced registration application category I
		(a)	in respect of a medicinal product containing 3 or fewer active ingredients	£539
		(b)	in any other case	£807
5. Change of ownership application				£442

(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) £1,077, 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) £2,154, 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 £7,186 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 £638 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 £2,154 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.

Online sellers of medicines U.K.

36.  The fee payable under regulation 13 in connection with an application to be included on the list of online sellers of medicines is £100.

PART 3 U.K. Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States

Outgoing mutual recognition applications U.K.

37.—(1) The fee payable for regulatory assistance under regulation 17 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 authorisation was granted in the United Kingdom (the application relating to that authorisation 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 £41,573;

(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 £2,564;

(c) each subsequent application for regulatory assistance (“subsequent application”), the fee is £27,308; 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 £2,564.

(3) In the case where the application to the licensing authority relates to a medicinal product for which a marketing authorisation 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 £10,753;

(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 £2,564;

(c) each subsequent application for regulatory assistance (“subsequent application”), the fee is £7,133; 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 £2,564.

(4) In the case where the application to the licensing authority relates to a medicinal product for which a marketing authorisation 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 £4,282;

(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 £2,564;

(c) each subsequent application for regulatory assistance (“subsequent application”), the fee is £3,567; 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 £2,564.

(5) In the case where the application to the licensing authority relates to a medicinal product for which a marketing authorisation 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 £2,564;

(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 £2,564;

(c) each subsequent application for regulatory assistance (“subsequent application”), the fee is £2,564; 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 £2,564.

(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 16.

PART 4 U.K. Capital Fees for Applications for Variations of Authorisations, Licences and Registrations

Marketing authorisations U.K.

38.—(1) Unless sub-paragraph (2) or any of paragraphs 39 to 42 and 51 to 53 applies, the fee payable under regulation 19(1) in connection with an application for a variation to the terms of a marketing authorisation of a kind described in column 1 of the appropriate table is the fee specified in the corresponding entry in column 2 of the appropriate table.

(2) This paragraph applies—

(a) to an application for a variation to the terms of a marketing authorisation of a kind described in item 1(c) or 2(c) in Table 1 or item 3 in Table 2; and

(b) where the application only concerns a new source or supply of a substance listed in Part 7 of this Schedule.

(3) If paragraph (2) applies, the appropriate fee for an application of the kind described—

(a) in item 1(c) of column 1 to Table 1, is the amount specified for an application of that type in item 1(b) of column 2;

(b) in item 2(c) of column 1 to Table 1, is the amount specified for an application of that type in item 2(b) of column 2;

(c) in item 3 of column 1 of Table 2, is the amount specified for item 2 in column 2 of Table 2.

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

(a) in respect of an application for a variation of a marketing authorisation which is within the scope of Chapter II (variations to marketing authorisations granted in accordance with Directive 87/22/EEC, Chapter 4 of Directive 2001/82/EC or Chapter 4 of Directive 2001/83/EC) of Commission Regulation (EC) No 1234/2008, Table 1;

(b) in respect of an application for a variation of a marketing authorisation which is within the scope of Chapter IIa (variations to purely national marketing authorisations) of Commission Regulation (EC) 1234/2008F17 [F18 and of marketing authorisations in force in Great Britain], Table 2;

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

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

(6) In Table 2 “UK national application” means an application for a variation to the terms of a UK national marketing authorisation within the meaning of Article 2(9) of Commission Regulation (EC) 1234/2008.

[F19 Table 1

Fees for applications for variations of marketing authorisations falling within the scope of Chapter II of Commission Regulation (EC) No 1234/2008

Column 1Kind of variation		Column 2Fee payable
1. Application for a single kind variation
(a)	Type IB Application	£277
(b)	Type II Application	£277
(c)	Type II Complex Variation Application	£2,493
(d)	Extended Type II Complex Variation Application	£7,693
2. Applications for a Group
(a)	Minor Variation (Type IB) Group Application	£277
(b)	Major Variation (Type II) Group Application	£496
(c)	Major Variation (Type II) Complex Group Application	£2,703
(d)	Major Variation (Type II) Extended Complex Group Application	£7,883]

Table 2

Fees for applications for variations of marketing authorisations falling within the scope of Chapter IIa of Commission Regulation (EC) No 1234/2008 [F20 and of marketing authorisations in force in Great Britain]

Column 1Kind of national variation	Column 2Fee payable
1. National Type 1B Application	£277
2. National Type II Application	£734
3. National Type II Complex Variation Application	£8,309
4. National Type II Extended Complex Variation Application	£25,643
5. National Type IB Minor Variation Group Application	£622
6. National Type II Major Variation Group Application	£1,652
7. National Type II Major Variation Complex Group Application	£9,010
8. National Type II Major Variation Extended Complex Group Application	£26,276
[F21 9 Variation of a UKMA(GB) which was granted following an application made under the unfettered access route, provided a corresponding variation has been approved to the related UKMA(NI) for the same product	£nil
10 Variation of a UKMA(GB) which was granted following an application made under the unfettered access route, provided a corresponding variation has been approved to the related European Union marketing authorisation for the same product	Apply fees and fee categories in Table 1
11 Variation of a UKMA(UK) or a UKMA(GB) which was granted following an application other than an application made under the unfettered access route, where the medicinal product concerned has already been granted a marketing authorisation by a competent authority of an EEA State under Article 28 of the 2001 Directive, provided a corresponding variation has been approved to the related marketing authorisation or UKMA(NI) for the same product	Apply fees and fee categories in Table 1
12 Variation of a UKMA(GB) which was granted following an application where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), provided a corresponding variation has been approved to the related European Union marketing authorisation or UKMA(NI) for the same product	Apply fees and fee categories in table 1]

Table 3

Fees for reclassification variation applications

Column 1Kind of reclassification variation				Column 2Fee payable
Application falling within the category described in—
		(a)	paragraph 15(a)	£11,992
		(b)	paragraph 15(b)	£8,162

Textual Amendments

F17 Chapter IIa of the Regulation was inserted by Commission Regulation (EU) No 712/2012 (OJ No L 209, 4.8.2012, p4)

F18 Words in Sch. 2 para. 38(4)(b) inserted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 7(9)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(vii))

F19 Sch. 2 para. 38(6) Table 1 substituted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 7(9)(b)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(vii))

F20 Words in Sch. 2 para. 38(6) Table 2 heading inserted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 7(9)(b)(ii)(aa) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(vii))

F21 Words in Sch. 2 para. 38(6) Table 2 inserted (31.12.2020) by S.I. 2019/775, Sch. 1 para. 7(9)(b)(ii)(bb) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(vii))

Variation of marketing authorisations U.K.

39.—(1) Subject to sub-paragraph (3) [F22 and paragraph 39A] , if an application to vary a marketing authorisation of a kind described in sub-paragraph (2) is—

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

(b) made within 5 years of the date of grant of the marketing authorisation; 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 19(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 authorisation 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 [F23 an orphan marketing authorisation].

(3) Sub-paragraph (1) and (2) shall not apply where the first application for variation of the marketing authorisation relates to a therapeutic area, in respect of which the applicant would be entitled (had the applicant not already held a marketing authorisation) to apply for a marketing authorisation to which point 6 of Part II of Annex I to the 2001 Directive applies or which is in respect of [F24 a medicinal product which meets the orphan criteria listed in regulation 50G(2) of the Human Medicines Regulations].

Textual Amendments

F22 Words in Sch. 2 para. 39(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(10)(a) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

F23 Words in Sch. 2 para. 39(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(10)(b) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

F24 Words in Sch. 2 para. 39(3) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(10)(c) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

[F25 Variation of orphan marketing authorisations: small and medium companies U.K.

39A.— (1) Subject to sub-paragraph (2), if an application to vary an orphan marketing authorisation is made by, or on behalf of, a small or a medium company within 12 months of the date of grant of the marketing authorisation, the fee payable for that variation application shall be waived.

(2) Sub-paragraph (1) does not apply to an application to authorise use of the medicinal product in a new therapeutic area which does not meet the orphan criteria listed in regulation 50G(2) of the Human Medicines Regulations.]

Textual Amendments

F25 Sch. 2 para. 39A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(11) (with Sch. 1 para. 11); 2020 c. 1, Sch. 5 para. 1(1)

Reclassification of marketing authorisations U.K.

40.—(1) Where an application is a reclassification variation application to which this paragraph applies, the fee payable under regulation 19(1) in connection with the application for variation of a marketing authorisation is £734.

(2) This paragraph applies to a reclassification variation application which would have the effect that a medicinal product to which the marketing authorisation 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 authorisation or a European Union marketing authorisation 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.

[F26 Fees where an application for a variation or an extension of a European Union marketing authorisation had been made before IP completion day U.K.

40A.— (1) Paragraph (2) applies where, before IP completion day —

(a) an application for a variation to which paragraph 11(7) of Schedule 33A to the Human Medicines Regulations applies, has been made to the EMA; and

(b) the Committee for Medicinal Products for Human Use has adopted a request for supplementary information to be sent to the applicant, or, in the case of an extension, day 120 has passed.

(2) Where this paragraph applies and the holder of a converted EU marketing authorisation submits the application to the licensing authority in order to have the variation made to the converted EU marketing authorisation, the fee payable under regulation 19(1) shall be waived.

(3) In this paragraph—

“day 120” means the day during the assessment of an extension on which the Committee for Medicinal Products for Human Use adopts the list of questions, as well as the overall conclusions and review of the scientific data, to be sent to the applicant;

“converted EU marketing authorisation” has the meaning given in paragraph 6(1) and (2) of Schedule 33A to the Human Medicines Regulations; and

“extension” has the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations.]

Textual Amendments

F26 Sch. 2 para. 40A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(12) (with Sch. 1 para. 11) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(viii)(aa)(bb)); 2020 c. 1, Sch. 5 para. 1(1)

Variation of marketing authorisation: national homoeopathic products U.K.

41.  The fee payable under regulation 19(1) in connection with an application for a variation of a marketing authorisation in respect of a national homoeopathic product is—

(a) £243 where the application is a standard variation application for a homoeopathic medicinal product;

(b) £374 where the application is a new indication variation application; and

(c) £123 for any other application.

Variation of parallel import licence U.K.

42.—(1) The fee payable under regulation 19(1) in connection with an application for variation of a parallel import licence is—

(a) £11,992 if, were the marketing authorisation 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 38 of this Schedule does not apply;

(b) £8,162 if, were the marketing authorisation 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 38 of this Schedule does not apply; and

(c) £357 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 authorised 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 9 of Schedule 7 applies, a change consequential upon any or any combination of the following—

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

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

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

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

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

(vi) a change of ownership of the marketing authorisation for the product in the country where the product originates,

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

(viii) a change to the address of the holder of the marketing authorisation 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 authorisation was not a parallel import licence, the application for that variation would be a reclassification variation application to which paragraph 40 of this Schedule applies.

Manufacturer's authorisations and licences U.K.

43.  Unless the fee in paragraph 44 is payable or paragraph 51 applies, the fee payable under regulation 19(1) in connection with an application for variation of a manufacturing authorisation or a manufacturer's licence is—

(a) £257 in the case of a manufacturer's licence referred to in paragraph 30(2); and

(b) £514 in any other case.

Variation of manufacturer's authorisations and licences U.K.

44.  The fee payable under regulation 19(1) in connection with an application for variation of a manufacturing authorisation or a manufacturer's licence is £257 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 U.K.

45.  Unless the fee in paragraph 46 is payable or paragraph 51 applies, the fee payable under regulation 19(1) in connection with an application for a variation of a wholesale dealer's licence is £486.

Variation of wholesale dealer's licence U.K.

46.  The fee payable under regulation 19(1) in connection with an application for variation of a wholesale dealer's licence is £257 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.

Variation of a broker's registration U.K.

47.  The fee payable under regulation 19(1) in connection with an application for variation of a broker's registration is £257 in respect of each variation applied for which consists of a change to the registration not requiring an inspection.

Variation of an active substance registration U.K.

48.  The fee payable under regulation 19(1) in connection with an application for variation of an active substance registration is £257 in respect of each variation applied for which consists of a change to the registration not requiring an inspection.

Clinical trial authorisations U.K.

49.—(1) A fee of £225 is payable under regulation 20(2)(a) in connection with a notice of amendment relating to an amendment to the dossier, or to the protocol, related to a request for authorisation to conduct a clinical trial.

Traditional herbal registrations U.K.

50.  Unless paragraph 51 applies, the fee payable under regulation 19(1) in connection with an application for variation of a traditional herbal registration is—

(a) £240 if the application is a standard variation application;

(b) £635 if the application is a complex variation application;

(c) £7,186 if the application is a new excipient variation application; and

(d) £152 if the application is an administrative variation application.

Identical variations U.K.

51.—(1) Unless paragraph 52 or 53 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 authorisation 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 19(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 U.K.

52.—(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 authorisation holder and all of the applications are for identical kinds of variations, the fee payable under regulation 19(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 U.K.

53.  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 19(1)—

(a) if one or more of the applications is an application to which paragraph 40 does not apply—

(i) in connection with the first application to which paragraph 40 does not apply, is the appropriate amount specified in this Part of the Schedule;

(ii) in connection with each other application to which paragraph 40 does not apply, the fee payable is £734; and

(iii) in connection with each other application to which paragraph 40 does apply, the fee payable is £367; 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, the fee payable is £367.

PART 5 U.K. Capital Fees for Assessment of Labels and Leaflets

A set of changes U.K.

54.—(1) Unless paragraph 55 applies, the fee payable under regulation 25(1) in connection with a set of proposed changes to the labelling or the package leaflet of a medicinal product is—

(a) £518, in respect of a product which is the subject of a United Kingdom marketing authorisation (other than a parallel import licence); and

(b) £328, 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 25(1) is £186.

(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) of the 2001 Directive – inclusion of Braille on the labelling” published by the licensing authority and available on its website F27 .

Textual Amendments

F27 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 151 Buckingham Palace Road, London, SW1W 9SZ or by sending an email to [e-mail].

More than one set of changes proposed U.K.

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

(2) This paragraph applies where more than one set of proposed changes falling within regulation 25(1) is submitted by the same marketing authorisation 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 25(1) is—

(a) in connection with the first set of proposed changes considered by the licensing authority, the appropriate amount specified in paragraph 54; and

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

[F28 PART 6 U.K. Capital Fee for the Renewal of a Marketing Authorisation

Textual Amendments

F28 Sch. 2 Pts. 6-6B, substituted for Sch. 2 Pt. 6 (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(13) (with Sch. 1 para. 11) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(ix)(aa)(bb)); 2020 c. 1, Sch. 5 para. 1(1)

Renewal of a marketing authorisation U.K.

56.   Unless paragraph 57 applies, the fee payable under regulation 27A in connection with an application for the renewal of a United Kingdom marketing authorisation is—

(a) in respect of an application for renewal of a UKMA(GB) granted under the unfettered access route, £747;

(b) in respect of an application for renewal of a UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), £747;

(c) in all other cases, £9,682.

Renewal of multiple marketing authorisations U.K.

57.— (1) This sub-paragraph applies if more than one application falling within regulation 27A 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 and therapeutic indications, and the marketing authorisations for those products have the same date for renewal.

(2) The fee payable under regulation 27A for applications to which sub-paragraph (1) applies is—

(a) in respect of applications for renewal of more than one UKMA(GB) granted under the unfettered access route or UKMA(GB) where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), and provided a corresponding renewal application has been made to the related European Union marketing authorisation or UKMA(NI) for the same product—

(i) £747 for the first application considered by the licensing authority; and

(ii) £747 for each other application;

(b) in all other cases—

(i) £9,682 for the first application considered by the licensing authority; and

(ii) £747 for each other application.

PART 6A U.K. Capital Fee for Conducting a Major Safety Review

57A.   The fee payable under regulation 19D(1) in connection with the carrying out of a major safety review is— U.K.

(a) £51,286, where one or two active ingredients, or combinations of active ingredients, are included in the assessment;

(b) £59,595, where three active ingredients, or combinations of active ingredients, are included in the assessment;

(c) £67,904, where four active ingredients, or combinations of active ingredients, are included in the assessment; or

(d) £76,213, where five or more active ingredients, or combinations of active ingredients, are included in the assessment.

PART 6B U.K. Capital Fee for Testing of Samples by the Appropriate Authority

57B.— (1) Unless sub-paragraph (2) applies, the fee payable under regulation 19F(1) in connection with the submission of a sample of a batch of a medicinal product 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. U.K.

(2) This sub-paragraph applies where—

(a) the holder of the marketing authorisation submits, with a sample of a batch of medicinal product, a certificate issued by a laboratory in a designated country for batch testing and certification of biological medicinal products that relates to the sample of the batch submitted; and

(b) on the basis of the documentation submitted with the sample, the appropriate authority considers that it is only necessary to carry out a paper based assessment of the sample.

(3) Where sub-paragraph (2) applies, the fee payable under regulation 19F(1) in connection with the submission of a sample of a batch of medicinal product of a kind described in column 1 of the following table is the fee specified in the corresponding entry in column 3 of that table.

(4) Where a product falls within more than one of the Bands referred to in the following table, the product is to be treated as if it only falls within the Band which attracts the highest fee.

Fees for testing of samples

Column 1Product Type				Column 2Fee payable where the licensing authority carries out a full assessment	Column 3Fee payable where the licensing authority carries out a paper-based assessment
1. Plasma pools which require—
		(a)	three or fewer tests	£180	£90
		(b)	four or five tests	£215	£90
		(c)	six or more tests	£230	£90
2. Band A				£1,660	£305
3. Band B				£1,910	£305
4. Band C				£2,340	£305
5. Band D				£3,690	£677
6. Band E				£6,410	£677
7. Band F				£10,350	£677

(5) In this paragraph—

“Band A” means a single component product, other than Botulinum toxin, requiring five or fewer in vitro tests;

“Band B” means Factor VIII, Factor IX or intravenous Immunoglobulin;

“Band C” means a multi-component product, or Botulinum toxin, requiring five or fewer in vitro tests;

“Band D” means a product requiring six to nine in vitro tests;

“Band E” means a product requiring—

(a)

ten or more in vitro tests, or

(b)

one or more in vivo tests;

“Band F” means a product—

(a)

which requires one or more tests that must be carried out under containment measures applicable to hazard Group 3 or 4 biological agents under the Control of Substances Hazardous to Health Regulations 2002 ; or

(b)

requires the use of human cells or tissues as part of its testing;

“Multi-component product” means a product containing two or more analytes that require testing; and

“Single component product” means a product containing a single analyte that requires testing.]

PART 7 U.K. Relevant Substances

Substances listed for the purposes of paragraph 24(2)(b) and (4)(b) and 38(2)(b) U.K.

58.—(1) The substances listed for the purposes of paragraphs 24(2)(b) and (4)(b) and 38(2)(b) (fees payable where the application concerns certain substances) are—

• — Acetic Acid

• — Aluminium Chloride

• — Aluminium Hydroxide

• — Aluminium Sulfate

• — Ammonia

• — Ammonium Bicarbonate

• — Ammonium Chloride

• — Ascorbic Acid

• — Barium Sulfate

• — Benzoic Acid

• — Benzoyl Peroxide

• — Benzyl Alcohol

• — Benzyl Benzoate

• — Bismuth Subgallate

• — Calamine

• — Calcium Acetate

• — Calcium Carbonate

• — Calcium Chloride

• — Calcium Gluconate

• — Calcium Glycerophosphate

• — Calcium Hydroxide

• — Calcium Lactate

• — Calcium Phosphate

• — Charcoal

• — Chlorobutanol

• — Chlorocresol

• — Citric Acid

• — Coal Tar

• — Ethanol

• — Ethanolamine

• — Ferric Chloride

• — Ferrous Fumarate

• — Ferrous Gluconate

• — Ferrous Sulfate

• — Formaldehyde Solution

• — Glucose

• — Glycine

• — Hydrogen Peroxide

• — Iodine

• — Isopropyl Alcohol

• — Isopropyl Myristate

• — Kaolin

• — Lactic Acid

• — Lactose

• — Lactulose

• — Lithium Carbonate

• — Lithium Citrate

• — Magnesium Acetate

• — Magnesium Carbonate

• — Magnesium Chloride

• — Magnesium Hydroxide

• — Magnesium Oxide

• — Magnesium Sulfate

• — Magnesium Trisilicate

• — Malic Acid

• — Manganese Sulfate

• — Oleic Acid

• — Paraffin

• — Phenol

• — Phosphoric Acid

• — Potassium Acetate

• — Potassium Bicarbonate

• — Potassium Chloride

• — Potassium Citrate

• — Potassium Dihydrogen Phosphate

• — Potassium Hydrogen Tartrate

• — Potassium Hydroxide

• — Potassium Iodate

• — Potassium Iodide

• — Potassium Nitrate

• — Silver Nitrate

• — Sodium Acetate

• — Sodium Ascorbate

• — Sodium Bicarbonate

• — Sodium Carbonate

• — Sodium Chloride

• — Sodium Citrate

• — Sodium Dihydrogen Phosphate

• — Sodium Fluoride

• — Sodium Hydroxide

• — Sodium Iodide

• — Sodium Lactate

• — Sodium Sulfate

• — Sorbic Acid

• — Sucrose

• — Sulpher

• — Tar

• — Tartaric Acid

• — Undecenoic Acid

• — Urea

• — Wool Alcohols

• — Wool Fat

• — Zinc Acetate

• — Zinc Chloride

• — Zinc Oxide

• — Zinc Sulfate

• — Zinc Undecenoate

(2) The list of substances under this Part includes any dried, anhydrous, hydrate, hydrous, activated, strong, light, heavy and coloured forms of substances listed under paragraph (1) that are the subject of a pharmacopoeial monograph of the European Pharmacopoeia or the British Pharmacopoeia.