Regulation 146 Obligation in relation to product information
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.
In this regulation “current scientific knowledge” includes the conclusions of the assessment and recommendations made public by means of—
in the case of a medicinal product for sale or supply in Northern Ireland—
the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004, and
the UK web-portal established in accordance with regulation 203(1);
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).
Annotations
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)