Information on the regulation of medicines for human use in the european union (eu), with a focus on the centralised procedure The european medicines agency (ema) plays a key role in this procedure. 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. The european medicines agency (ema) publishes detailed information on the medicines assessed by the committee for medicinal products for human use (chmp) and committee for medicinal products for veterinary use (cvmp). 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.
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 comprehension. 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 applications at the time of submission. The european medicines agency (ema) evaluates and recommends the authorisation of medicines marketed in the european union (eu)
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