Regulation 76 Obligation in relation to product information

United Kingdom

(1)

The holder of a UK marketing authorisation F1or parallel import licence for a medicinal product must ensure that the product information relating to the product is kept up to date with current scientific knowledge.

F2(2)

In this regulation “current scientific knowledge” includes the conclusions of the assessment and recommendations made public by means of—

(a)

in the case of a medicinal product authorised for sale or supply by a UKMA(NI) or a F3UKMA(UK)(Category 2)—

(i)

the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004, and

(ii)

the UK web-portal established in accordance with regulation 203(1);

(b)

in the case of a medicinal product authorised for sale or supply by a UKMA(GB) F4or a UKMA(UK)(Category 1), the UK web-portal established in accordance with regulation 203(1).

Annotations

Textual amendments

F1: Words in reg. 76(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. 76(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)(m)
F2: Reg. 76(2) substituted (31.12.2020) by S.I. 2019/775, reg. 84 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 61)
F3: Words in reg. 76(2)(a) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 60(a)
F4: Words in reg. 76(2)(b) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 60(b)