X.C.6. Transparency

Pursuant to Article 23 of Regulation 726/2004, the Agency will make publicly available the list of the names and active substances of all medicinal products approved in the EU subject to additional monitoring and the general criteria to include medicinal products in the list. The national competent authority shall also make publicly available the list of medicinal products authorised in their territory that are subject to additional monitoring.

The list will include an electronic link(s) to the relevant web-portal where the product information and the summary of the RMP are publicly available.