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Public Health
News announcement16 June 2010Directorate-General for Health and Food Safety

"Pharmaceuticals in the European Union" are now part of the EC-Public Health website

"Pharmaceuticals in the European Union" are now part of the EC-Public Health website

The EU legal framework for medicinal products guarantees high standards of quality and safety. It also promotes the functioning of the internal market, with measures that encourage innovation and competiveness in Europe. It is based on the principle that medicinal products may be placed on the market only following a marketing authorisation granted by the competent authorities. A large body of legislation has developed around this principle with the progressive harmonisation of requirements implemented across the whole European Economic Area.

Today, medicinal products are authorised at EU level by the European Commission or at national level by the competent authorities of EU countries. Special rules exist for the authorisation of medicinal products for paediatric use, orphan medicines, traditional herbal medicines, vaccines and clinical trials. Once placed on the market, the safety of a medicinal product continues to be monitored throughout its entire lifespan through the EU system of pharmacovigilance.

The European Medicines Agency, established in 1995, underpins the centralised authorisation procedure and supports coordination between national competent authorities. The Agency is the hub of a European medicines network comprising over 40 national regulatory authorities guaranteeing a constant exchange and flow of information regarding the scientific assessment of medicinal products in the EU.

Legal framework

Medicines for children

Orphan medicines

Advanced therapies

Pharmaceutical committeeand expert groups

Clinical trials

Falsified medicines

EU Logo foronline sale of medicines

Good Manufacturing and Distribution Practices


Traditional herbalmedicines

Personalised medicine

Medicines andthe environment

Call for EMA committeesand board members

Veterinary medicinal products

International cooperation on pharmaceuticals

Pharmaceutical strategy for Europe


Publication date
16 June 2010
Directorate-General for Health and Food Safety