Regulation 116 Obligation in relation to product information

(1)

The holder of the certificate of registration for a medicinal product must ensure that the product information relating to the product is kept up to date with current scientific knowledge.

F1(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 by a COR(NI) or COR(UK)—

(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 by a COR(GB), the UK web-portal established in accordance with regulation 203(1).

Annotations

Textual amendments

F1: Reg. 116(2) substituted (31.12.2020) by S.I. 2019/775, reg. 107 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 81)