V.C.4. Transparency

The Agency and Member States shall make publically available, by means of the European medicines web-portal and the national medicines web-portals, public assessment reports and summaries of risk management plans [REG Art 26(1)(c), DIR Art 106(c)].

For centrally authorised medicinal products the Agency:

• makes public a summary of the RMP;
• includes tables relating to the RMP in the EPAR including the product information and any conditions to the marketing authorisation.

The national competent authorities will provide details of how they intend to implement the transparency measures at national level [by reference to DIR Art 106].e