[F1TITLE IX U.K. PHARMACOVIGILANCE

CHAPTER 2 U.K. Transparency and communications

Article 106 U.K.

Each Member State shall set up and maintain a national medicines web-portal which shall be linked to the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004. By means of the national medicines web-portals, the Member States shall make publicly available at least the following:

(a)

public assessment reports, together with a summary thereof;

(b)

summaries of product characteristics and package leaflets;

(c)

summaries of risk management plans for medicinal products authorised in accordance with this Directive;

(d)

the list of medicinal products referred to in Article 23 of Regulation (EC) No 726/2004;

(e)

information on the different ways of reporting suspected adverse reactions to medicinal products to national competent authorities by healthcare professionals and patients, including the web-based structured forms referred to in Article 25 of Regulation (EC) No 726/2004.]

Textual Amendments