The Human Medicines Regulations 2012 No. 1916

PART 7 U.K. Traditional herbal registrations

Obligations of holder of traditional herbal registration U.K.

Obligation in relation to product information U.K.

146.—(1) The holder of the traditional herbal 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 for sale or supply in Northern Ireland—

(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 for sale or supply in Great Britain only, the UK web-portal established in accordance with regulation 203(1).]

Textual Amendments

F1 Reg. 146(2) substituted (31.12.2020) by S.I. 2019/775, reg. 129 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 97)