The Human Medicines Regulations 2012

Conditions of UK marketing authorisation [F1 or parallel import licence]: general U.K.

59.—(1)  [F2 Unless paragraph (1A) applies the licensing authority] may—

(a) grant a UK marketing authorisation subject to one or more of the conditions in paragraph (2); or

(b) vary or remove a condition in paragraph (2) to which the UK marketing authorisation is subject.

[F3 (1A) Where the application concerns a parallel import licence, the licensing authority may—

(a) grant a parallel import licence subject to one or more of the conditions in paragraph (2)(a), (c), (d) or (e); or

(b) vary or remove a condition in paragraph (2)(a), (c), (d) or (e) to which the parallel import licence is subject.]

(2) Those conditions are—

(a) to take certain measures for ensuring the safe use of the medicinal product and include them in the risk management plan;

(b) to conduct post-authorisation safety studies;

(c) to comply with obligations on the recording or reporting of suspected adverse reactions which are stricter than those referred to in Part 11;

(d) any other conditions or restrictions with regard to the safe and effective use of the medicinal product;

(e) the existence of an adequate pharmacovigilance system; and

(f) to conduct post-authorisation efficacy studies where concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed.

(3) An obligation to conduct such studies as are referred to in paragraph (2)(f) must be based on the delegated acts adopted pursuant to Article 22b of the 2001 Directive, while taking into account the scientific guidance referred to in Article 108a of the 2001 Directive.

(4) The marketing authorisation [F4 or parallel import licence] must lay down deadlines for the fulfilment of the conditions in paragraph (2) [F5 where relevant and necessary].

(5) The licensing authority must notify the EMA of any marketing authorisation that it has granted subject to a condition included in accordance with this regulation.

(6) The holder of the authorisation must incorporate any condition included in a marketing authorisation [F6 or parallel import licence] in accordance with this regulation into the risk management system for the product.

(7) Schedule 11 makes provision about advice and representations in relation to proposals to vary or remove a condition to which a UK marketing authorisation is subject.

Textual Amendments

F1 Words in reg. 59 heading 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. 59 heading inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(d)

F2 Words in reg. 59(1) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 8(2) and words in reg. 59(1) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 8(2)

F3 Reg. 59(1A) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 8(3) and reg. 59(1A) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 8(3)

F4 Words in reg. 59(4) 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. 59(4) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 4(2)(e)

F5 Words in reg. 59(4) substituted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 8(4) and words in reg. 59(4) substituted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 8(4)

F6 Words in reg. 59(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. 59(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)(e)