The Medicines (Products for Human Use) (Fees) Regulations 2016

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) 1234/2008F1 [F2 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.

[F3 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 [F4 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
[F5 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

F1 Chapter IIa of the Regulation was inserted by Commission Regulation (EU) No 712/2012 (OJ No L 209, 4.8.2012, p4)

F2 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))

F3 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))

F4 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))

F5 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) [F6 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 [F7 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 [F8 a medicinal product which meets the orphan criteria listed in regulation 50G(2) of the Human Medicines Regulations].

Textual Amendments

F6 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)

F7 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)

F8 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)

[F9 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

F9 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.

[F10 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

F10 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.