Information on the regulation of medicines for human use in the european union (eu), with a focus on the centralised procedure This complements information on medicines published on this website, which only includes medicines that the european medicines agency (ema) evaluates The european medicines agency (ema) plays a key role in this procedure.
Ty lee (@ema_bb0) - Urlebird
The purpose of the european medicines agency's (ema) certification scheme for human and veterinary medicines is to confirm the medicine's marketing authorisation status and that it complies with good manufacturing practice (gmp) standards.
While the majority of new, innovative medicines are evaluated by ema and authorised by the european commission in order to be marketed in the eu, most generic medicines and medicines available without a prescription are assessed and authorised at national level in the eu.
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. 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's committee for medicinal products for human use prepares scientific guidelines in consultation with regulatory authorities in the european union (eu) member states, to help applicants prepare marketing authorisation applications for human medicines
Guidelines reflect a harmonised approach of the eu member states and the agency on how to interpret and apply the.
