# The Medicines (Products for Human Use) (Fees) Regulations 2016, 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) 1234/2008 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.
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
£419
(b)
Type II Application
£419
(c)
Type II Complex Variation Application
£3,338
(d)
Extended Type II Complex Variation Application
£10,301
2. Applications for a Group
(a)
Minor Variation (Type IB) Group Application
£419
(b)
Major Variation (Type II) Group Application
£1,528
(c)
Major Variation (Type II) Complex Group Application
£3,619
(d)
Major Variation (Type II) Extended Complex Group Application
£10,555
Table 2
Fees for applications for variations of marketing authorisations falling within the scope of Chapter IIa of Commission Regulation (EC) No 1234/2008and of marketing authorisations in force in Great Britain
Column 1Kind of national variation
Column 2Fee payable
1. National Type 1B Application
£419
2. National Type II Application
£1,593
3. National Type II Complex Variation Application
£11,126
4. National Type II Extended Complex Variation Application
£40,173
5. National Type IB Minor Variation Group Application
£833
6. National Type II Major Variation Group Application
£2,212
7. National Type II Major Variation Complex Group Application
£12,065
8. National Type II Major Variation Extended Complex Group Application
£35,184
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)
£40,173
(b)
paragraph 15(b)
£10,929

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Source: https://www.legislation.gov.uk/uksi/2016/190/schedule/2/paragraph/38 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-38
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.