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

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))