IX.C.9. Transparency

In relation to the EU signal management process, the following information is published by the Agency on the European medicines web-portal:

• PRAC agendas;
• PRAC recommendations (for recommendations to update the product information, the agreed wording for the product information is published in all EU official languages, as well as Norwegian and Icelandic. Marketing authorisation holders can use these translations to update the product information of the medicinal products they are responsible for);
• cumulative list of all signals discussed by the PRAC with links to the relevant PRAC minutes;
• list of active substances subject to worksharing for signal management and the lead Member State appointed for monitoring those substances in the EudraVigilance database [IR Art 22(3)].

Outcomes of safety referrals and single assessments of PSURs (see GVP Module VII), which may be relevant to signal management, are also published (23).