Mar 2, 2020 · The European Medicines Agency's (EMA) Human Medicines Division oversees human medicines throughout their lifecycle. This includes the provision of guidance and advice …

EMA business hours over holiday period The European Medicines Agency's (EMA) office is closed from 18:00 on 22 December to 08:30 on 5 January

EMA strongly encourages applicants and marketing authorisation holders to follow the guidelines featured on this page. Applicants need to justify deviations from guidelines fully in their …

Check EMA's annual reports for insights into our regulatory procedures, activities, and achievements. The reports include an interactive timeline and figures and statistics for easy …

The European Medicines Agency (EMA) answers frequently asked questions (FAQs) about its work and scope.

On this page you can find several ways to contact the European Medicines Agency (EMA) depending on your need for assistance or type of request.

Oct 29, 2025 · The European Medicines Agency (EMA) publishes information on human medicines at various stages of their life cycle

Dec 10, 2025 · In the European Union (EU) they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended. …

Jun 6, 2024 · The European Medicines Agency (EMA) coordinates the European Union (EU) pharmacovigilance system and operates services and processes to support …

A set of documents describing the evaluation of a medicine authorised via the centralised procedure and including the product information, published on the European Medicines …