The Human Medicines (Amendment etc.) (EU Exit) (No. 2) Regulations 2021

PART 3 Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016

Amendment of regulation 19F (fee for testing of samples by the appropriate authority)

24.—(1) Regulation 19F(1) is amended as follows.

(2) In paragraph (1), after “regulation 60A” insert “or a batch testing requirement imposed under regulation 60B”.

(3) In paragraph (3)—

(a) for ““appropriate authority” and “batch testing condition”” substitute ““appropriate authority”, “batch testing condition” and “batch testing requirement””; and

(b) after “regulation 60A” insert “or 60B (as appropriate)”.

Amendment of regulation 27A (fee for renewals of a marketing authorisation)

25.  In regulation 27A(2), after “in the case of a product for sale or supply in Great Britain” insert “, except where the marketing authorisation was granted under Chapter 4 of Title III of the 2001 Directive,”.

Amendment of regulation 46 (fees for applications for certificates)

26.  Omit regulation 46(2).

Amendment of Schedule 2 (capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates)

27.  In Schedule 2(3), in paragraph 56—

(a) in sub-paragraph (a), after “unfettered access route,” insert “provided a corresponding renewal has been made to the related European Union marketing authorisation or UKMA(NI) for the same product,”;

(b) in sub-paragraph (b), after “(an automatic recognition application),” insert “provided a corresponding renewal has been made to the related European Union marketing authorisation or UKMA(NI) for the same product,”;

(c) for sub-paragraph (c), substitute—

“(c) in respect of an application for renewal of a UKMA(UK) or a UKMA(GB) granted under an application other than 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 renewal has been made to the related marketing authorisation or UKMA(NI) for the same product, £747;”;

(d) at the end insert—

“(d) in all other cases, £9,682.”.

Amendment of Schedule 5 (fees for certificates of registration)

28.  For the table in Schedule 5, substitute—

“Column 1 Type of application			Column 2 Fees for applications in respect of products prepared from not more than 5 homoeopathic stocks	Column 3 Fees 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.		£159	£393
2	An application in respect of a product which is either—		£478	£704
	(a)	Prepared solely from repeat stocks; or
	(b)	Is of a repeat formulation.
3	A mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associate application under the unfettered access route for a COR(GB).		£501	£638
4	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 COR(GB).		£430	£563
5	Any other application.		£790	£1,034”.

(1)

Regulation 19F was inserted by S.I. 2019/775 (as amended by S.I. 2020/1488).

(2)

Regulation 27A was inserted by S.I. 2019/775 (as amended by S.I. 2020/1488).

(3)

Schedule 2 was amended by S.I. 2019/775 (as amended by S.I. 2020/1488).