The Human Medicines Regulations 2012

Obligation to provide information relating to safety etc U.K.

75.—(1) The holder of a UK marketing authorisation [F1 or parallel import licence] must provide the licensing authority with any new information that might entail the variation of the authorisation.

(2) The holder [F2 of a UK marketing authorisation] must, in particular, provide the licensing authority with the following information—

(a) information about any prohibition or restriction imposed in relation to the product to which the authorisation relates by the competent authority of any country in which the product is on the market;

(b) positive and negative results of clinical trials or other studies in all indications and populations, whether or not included in the marketing authorisation;

(c) data on the use of the medicinal product where such use is outside the terms of the marketing authorisation; and

(d) any other information that the holder considers might influence the evaluation of the benefits and risks of the product.

[F3 (2A) The holder of a parallel import licence must, in particular, provide the licensing authority with—

(a) information about any prohibition or restriction imposed in relation to the product to which the licence relates by the competent authority of any country in which the product is on the market; and

(b) other information that the holder considers might influence the evaluation of the benefits and risks of the product.]

(3) Information within paragraph (1) [F4 to (2A)] must be provided as soon as is reasonably practicable after the holder becomes aware of it.

(4) The licensing authority may require the holder of a UK marketing authorisation to provide the authority with information that—

(a) is specified by the licensing authority; and

(b) demonstrates that the positive therapeutic effects of the product to which the authorisation relates continue to outweigh the risks of the product to the health of patients or of the public.

[F5 (4A) The licensing authority may require the holder of a parallel import licence to provide further information specified by the licensing authority.]

(5) The information that may be required under paragraph (4) [F6 or (4A)] includes information arising from use of the product—

[F7 (a) in a country other than the United Kingdom;]

(b) outside the terms of the [F8 UK] marketing authorisation,

including use in clinical trials.

(6) If the information supplied under paragraph (1), (2)[F9 , (4) or (4A)] entails the variation of the UK marketing authorisation [F10 or parallel import licence], the holder must make an application to the licensing authority to that effect as soon as is reasonably practicable after becoming aware of the information.

(7) The licensing authority may require the holder of a UK marketing authorisation to provide the authority with proof of the control methods employed by the manufacturer of the product to which the authorisation relates.

(8) The holder of a UK marketing authorisation [F11 or parallel import licence] must provide the licensing authority with information it requests under paragraphs [F12 (4), (4A) or] (7)—

(a) where the period within which the information must be provided is specified in a written notice given to the holder by the licensing authority, before the end of that period; or

(b) otherwise, as soon as is reasonably practicable after receipt of the request.

Textual Amendments

F1 Words in reg. 75(1) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 75(1) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(l)

F2 Words in reg. 75(2) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 14(2) and words in reg. 75(2) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 14(2)

F3 Reg. 75(2A) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 14(3) and reg. 75(2A) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 14(3)

F4 Words in reg. 75(3) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 14(4) and words in reg. 75(3) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 14(4)

F5 Reg. 75(4A) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 14(5) and reg. 75(4A) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 14(5)

F6 Words in reg. 75(5) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 14(6) and words in reg. 75(5) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 14(6)

F7 Reg. 75(5)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 83(a); 2020 c. 1, Sch. 5 para. 1(1)

F8 Word in reg. 75(5)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 83(b); 2020 c. 1, Sch. 5 para. 1(1)

F9 Words in reg. 75(6) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 14(7) and words in reg. 75(6) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 14(7)

F10 Words in reg. 75(6) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 75(6) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(l)

F11 Words in reg. 75(8) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 4 and words in reg. 75(8) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(l)

F12 Words in reg. 75(8) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 14(8) and words in reg. 75(8) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 14(8)