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)”.
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,”.
26. Omit regulation 46(2).
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.”.
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”. |
Regulation 19F was inserted by S.I. 2019/775 (as amended by S.I. 2020/1488).
Regulation 27A was inserted by S.I. 2019/775 (as amended by S.I. 2020/1488).
Schedule 2 was amended by S.I. 2019/775 (as amended by S.I. 2020/1488).