The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

Insertion of regulations 19A-19F (fees for plasma master files, vaccine antigen master files, post-authorisation safety studies, major safety reviews, periodic safety update reports and batch testing) U.K.

2.  After regulation 19, insert—

“Fees for certification of plasma master files

19A.— (1) The fee payable by a person who submits a plasma master file to the licensing authority for scientific and technical evaluation in accordance with paragraph 1.1(c), second indent, of Part III of Annex I to the 2001 Directive, is £8,309.

(2) The fee payable by a person who submits a plasma master file to the licensing authority for re-certification in accordance with paragraph 1.1(c), third indent, of Part III of Annex I to the 2001 Directive is—

(a) £277, where there are no changes to the plasma master file other than an update to epidemiological data; or

(b) £734, in any other case.

Fee for certification of vaccine antigen master files

19B.   The fee payable by a person who submits a vaccine antigen master file to the licensing authority for scientific and technical evaluation in accordance with paragraph 1.2(c), first indent, of Part III of Annex I to the 2001 Directive, is £8,309.

Fees for assessment of post-authorisation safety studies

19C.— (1) This regulation applies to post-authorisation safety studies initiated, managed or financed by the holder of a marketing authorisation in compliance with obligations imposed under regulation 59 or 61 of the Human Medicines Regulations.

[F1 (2) The fee payable by the holder of a marketing authorisation upon submission of the draft protocol for a post-authorisation safety study in accordance with regulation 199(2) of the Human Medicines Regulations—

(a) where the authorisation for the medicinal product concerned is a UKMA(GB) granted under the unfettered access route or a UKMA(GB) granted where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), and provided a corresponding draft protocol has been submitted in respect of the related European Union marketing authorisation or UKMA(NI) for the same product, is £734;

(b) where sub-paragraph (a) does not apply and—

(i) the study is to be conducted in the United Kingdom only; or

(ii) the authorisation for the product which is the subject of the study authorises sale or supply in Great Britain only,

is £8,309; and

(c) in any other case, is £734.]

[F2 (3)  The fee payable by the holder of a marketing authorisation upon submission of the final study report for a post-authorisation safety study in accordance with regulation 201(2) of the Human Medicines Regulations—

(a) where the authorisation for the medicinal product concerned is a UKMA(GB) granted under the unfettered access route or a UKMA(GB) granted where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), and provided a corresponding final study report has been submitted in respect of the related European Union marketing authorisation or UKMA(NI) for the same product, is £734;

(b) where sub-paragraph (a) does not apply and—

(i) the study is to be conducted in the United Kingdom only; or

(ii) the authorisation for the product which is the subject of the study authorises sale or supply in Great Britain only,

is £8,309; and

(c) in any other case, is £734.]

Fee for carrying out a major safety review

19D.— (1) Where the licensing authority conducts a major safety review of a [F3 United Kingdom] marketing authorisation or traditional herbal registration, or a set of [F4 such] marketing authorisations or traditional herbal registrations, under regulation 196 of the Human Medicines Regulations, a fee is payable in accordance with Part 6A of Schedule 2.

(2) Unless paragraph (3) applies, the fee referred to in paragraph (1) is payable by the holder of the marketing authorisation or registration to which the review relates.

(3) Where the review relates to two or more authorisations or registrations the fee referred to in paragraph (1) is to be divided by the number of authorisations or registrations forming part of the review (“relevant authorisation or registration”) and each holder of a relevant authorisation or registration must pay that reduced fee in respect of each relevant authorisation or registration it holds.

Fee for assessment of periodic safety update reports

19E.— (1) This regulation applies where—

(a) a periodic safety update report has been submitted to the licensing authority under regulation 191 or 192 of the Human Medicines Regulations; and

(b) that periodic safety update report relates to a medicinal product which has a UK reference date within the meaning of regulation 193 of the Human Medicines Regulations.

(2) Where this regulation applies, the fee payable by the holder of a marketing authorisation or traditional herbal registration to which the periodic safety update report relates is—

(a) £890, in the case where no other periodic safety update reports relating to medicinal products with the same UK reference date are submitted; and

(b) £445, in any other case.

Fee for testing of samples by the appropriate authority

19F.— (1) Where a sample from a batch of a medicinal product is submitted to the appropriate authority in accordance with a batch testing condition imposed under regulation 60A of the Human Medicines Regulations, the fee payable by the holder of the marketing authorisation to which the medicinal product relates is the fee prescribed in Part 6B of Schedule 2 in connection with that submission.

(2) The fee payable by an applicant for a certified copy of a certificate confirming that the appropriate authority is satisfied that the batch is in conformity with the approved specifications is £50.

(3) In this regulation, and in Part 6B of Schedule 2, “appropriate authority” and “batch testing condition” have the same meaning as in regulation 60A of the Human Medicines Regulations.

Time for payment of fees under regulations 19A to 19F

19G.   All sums payable by way of fees under regulations 19A to 19F are payable on invoice.”.

Textual Amendments

F1 Words in Sch. 1 para. 2 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(c)(i)(aa)

F2 Words in Sch. 1 para. 2 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(c)(i)(bb)

F3 Words in Sch. 1 para. 2 inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(c)(ii)(aa)

F4 Word in Sch. 1 para. 2 inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(c)(ii)(bb)

Commencement Information

I1 Sch. 1 para. 2 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1