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Ema's role the european medicines agency (ema) facilitates development and access to medicines for countries within the european union (eu). These questions and answers (q&as) provide an overview of the european medicines agency's (ema) advice on issues that are typically addressed in discussions or meetings with marketing authorisation holders in the application phase. The european medicines agency (ema) evaluates and recommends the authorisation of medicines marketed in the european union (eu)
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Feedback from european medicine agency (ema) to the eu commission request to evaluate the feasibility of alternatives to replace titanium dioxide (tio2) in medicinal products and its possible impact on medicines’ availability The european medicines agency (ema) coordinates inspections to verify compliance with these standards and plays a key role in harmonising gmp activities at european union (eu) level. The european medicines agency (ema) is responsible for the scientific evaluation of centralised marketing authorisation applications (maa)
Once granted by the european commission, the centralised marketing authorisation is valid in all european union (eu) member states, iceland, norway and liechtenstein.
Once you have an ema account you can request access on behalf of your organisation for ema applications such as ctis*, spor, iris, eudravigilance and upd using the new access request process, here. This complements information on medicines published on this website, which only includes medicines that the european medicines agency (ema) evaluates Some of these registers cover both human and veterinary medicines. The revised variations regulation applies since 1 january 2025 for variation applications implemented and submitted to the european medicines agency (ema) from 1 january 2025.
