Regulation 19C Fees for assessment of post-authorisation safety studiesF1
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.
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—
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 F2£1,308;
where sub-paragraph (a) does not apply and—
the study is to be conducted in the United Kingdom only; or
the authorisation for the product which is the subject of the study authorises sale or supply in Great Britain only,
is F3£9,949; and
in any other case, is F4£1,308.
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—
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 F5£1,308;
where sub-paragraph (a) does not apply and—
the study is to be conducted in the United Kingdom only; or
the authorisation for the product which is the subject of the study authorises sale or supply in Great Britain only,
is £9,949; and
in any other case, is F6£1,308.
Annotations
Textual amendments
- F1
Regs. 19A-19G inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 2 (with Sch. 1 para. 11) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 188(c)(i)(aa)(bb)); 2020 c. 1, Sch. 5 para. 1(1)
- F2
Sum in reg. 19C(2)(a) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 15(a)(i)
- F3
Sum in reg. 19C substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 17
- F4
Sum in reg. 19C(2)(c) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 15(a)(iii)
- F5
Sum in reg. 19C(3)(a) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 15(b)(i)
- F6
Sum in reg. 19C(3)(c) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 15(b)(iii)