Paragraph 38 Marketing authorisations

(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) 1234/2008M1 F1and 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.

F2Table 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	F3£419
(b)	Type II Application	£419
(c)	Type II Complex Variation Application	F4£3,338
(d)	Extended Type II Complex Variation Application	F5£10,301
2. Applications for a Group
(a)	Minor Variation (Type IB) Group Application	F6£419
(b)	Major Variation (Type II) Group Application	F7£1,528
(c)	Major Variation (Type II) Complex Group Application	F8£3,619
(d)	Major Variation (Type II) Extended Complex Group Application	F9£10,555

Table 2

Fees for applications for variations of marketing authorisations falling within the scope of Chapter IIa of Commission Regulation (EC) No 1234/2008F10and of marketing authorisations in force in Great Britain

Column 1Kind of national variation	Column 2Fee payable
1. National Type 1B Application	F11£419
2. National Type II Application	F12£1,593
3. National Type II Complex Variation Application	F13£11,126
4. National Type II Extended Complex Variation Application	F14£40,173
5. National Type IB Minor Variation Group Application	F15£833
6. National Type II Major Variation Group Application	F16£2,212
7. National Type II Major Variation Complex Group Application	F17£12,065
8. National Type II Major Variation Extended Complex Group Application	F18£35,184
F199 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)	F20£40,173
	(b)	paragraph 15(b)	F21£10,929

Annotations

Textual amendments

F1: 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))
F2: 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))
F3: Sum in Sch. 2 para. 38(6) Table 1 Item 1(a)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(a)(i)(aa)
F4: Sum in Sch. 2 para. 38(6) Table 1 Item 1(c) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(a)(i)(bb)
F5: Sum in Sch. 2 para. 38(6) Table 1 Item 1(d) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(a)(i)(cc)
F6: Sum in Sch. 2 para. 38(6) Table 1 Item 2(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(a)(ii)(aa)
F7: Sum in Sch. 2 para. 38(6) Table 1 Item 2(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(a)(ii)(bb)
F8: Sum in Sch. 2 para. 38(6) Table 1 Item 2(c) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(a)(ii)(cc)
F9: Sum in Sch. 2 para. 38(6) Table 1 Item 2(d) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(a)(ii)(dd)
F10: 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))
F11: Sum in Sch. 2 para. 38(6) Table 2 Item 1 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(b)(i)
F12: Sum in Sch. 2 para. 38(6) Table 2 Item 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(b)(ii)
F13: Sum in Sch. 2 para. 38(6) Table 2 Item 3 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(b)(iii)
F14: Sum in Sch. 2 para. 38(6) Table 2 Item 4 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(b)(iv)
F15: Sum in Sch. 2 para. 38(6) Table 2 Item 5 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(b)(v)
F16: Sum in Sch. 2 para. 38(6) Table 2 Item 6 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(b)(vi)
F17: Sum in Sch. 2 para. 38(6) Table 2 Item 7 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(b)(vii)
F18: Sum in Sch. 2 para. 38(6) Table 2 Item 8 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(b)(viii)
F19: 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))
F20: Sum in Sch. 2 para. 38(6) Table 3 Entry (a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(c)(i)
F21: Sum in Sch. 2 para. 38(6) Table 3 Entry (b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(14)(c)(ii)

Marginal citations

M1: Chapter IIa of the Regulation was inserted by Commission Regulation (EU) No 712/2012 (OJ No L 209, 4.8.2012, p4)