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:

  1. (a)

    public assessment reports, together with a summary thereof;

  2. (b)

    summaries of product characteristics and package leaflets;

  3. (c)

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

  4. (d)

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

  5. (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.