What we publish on medicines and when

EMA publishes information on human medicines at various stages of their lifecycles, from early development through initial evaluation to post-authorisation changes, safety reviews and withdrawals of authorisation.

Guide to information on human medicines evaluated by EMAEMA has published a guide to the different types of information stakeholders can expect on this website about centrally and non-centrally authorised medicines, including the publication times and location:

PDF iconGuide to information on human medicines evaluated by EMA

For the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC), EMA publishes meeting highlights to communicate information of major public interest, usually the day after their meetings have ended.

As a matter of good practice, marketing authorisation holders, applicants and third parties should wait until EMA communication is published before publishing their own communication related to the committee's outcome.

In line with Good Pharmacovigilance Practice (GVP) Module XV, EMA gives advance notice of its safety-related publications to national competent authorities, the European Commission and the concerned marketing authorisation holders.

Marketing authorisation holders are also obliged to inform the Agency and relevant national competent authorities of their intention to publish information on the safety of medicines.

Importance of package leaflet

Human medicines: Applications for centralised marketing authorisation

Human medicines: Changes to centralised marketing authorisations

Human medicines: EU referrals

Human medicines: Other documents and procedures

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