PART 11U.K.Pharmacovigilance

Transparency and communicationsU.K.

Obligations on licensing authority in relation to national medicines web-portalU.K.

203.—(1) The licensing authority must set up and maintain a national medicines web-portal (“the UK web-portal”) F1...

(2) The licensing authority must make available publicly by means of the UK web-portal the following (at a minimum)—

(a)the assessment reports prepared or revised by the licensing authority under regulation 64(5) and (6) (duties of licensing authority in connection with determination), each with a summary;

(b)the summary of the product characteristics for the medicinal products concerned;

(c)the package leaflet for the medicinal products concerned;

(d)a summary of the risk management plan (if any) for the medicinal products concerned;

[F2(da)the list published by the licensing authority under, or which applies by virtue of, regulation 202A;]

(e)the list of medicinal products that are subject to additional monitoring referred to in Article 23 of Regulation (EC) No 726/2004; and

(f)information on the different ways of reporting suspected adverse reactions to medicinal products to the licensing authority by patients or their carers, health care professionals, coroners or procurators fiscal (including by way of the web-based structured forms referred to in Article 25 of Regulation (EC) No 726/2004).

Textual Amendments