F1TITLE IX PHARMACOVIGILANCE
CHAPTER 2 Transparency and communications
Article 106
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.