VII.C.7. Transparency

VII.C.7.1. Publication of PSUR-related documents on the European medicines and national medicines web-portals

The following documents shall be made publicly available by means of the European medicines webportal [DIR Art 107l, REG Art 26(g)]:

• list of EU reference dates and frequency of submission of PSURs (see VII C.3.);
• final assessment conclusions of the adopted assessment reports;
• PRAC recommendations including relevant annexes;
• CMDh position including relevant annexes and where applicable, detailed explanation on scientific grounds for any differences with the PRAC recommendations;
• CHMP opinion including relevant annexes and where applicable, detailed explanation on scientific grounds for any differences with the PRAC recommendations;
• European Commission decision.

The version and date of publication are reflected in each document as they define the issue of the PRAC recommendations, CHMP opinions, CMDh positions and European Commission decisions at a certain point of time.

Links between the European medicines web-portal and the National medicines web-portals should be made whenever possible and relevant.

Any personal or confidential data made public by the Agency or the competent authorities in Member States as referred to in paragraphs 2 and 3 of Article 106a of Directive 2001/83/EC shall be deleted unless considered necessary in terms of protection of the public health [DIR Art 106a(4)].