Medicinal products for human use

The EU legal framework for medicinal products for human use guarantees high standards of quality and safety of medicinal products and intends to promote the functioning of the internal market, with measures which 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 in the may be either authorised at EU level by the European Commission or at national level by Member States’ competent authorities. Special rules exist for the authorisation of medicinal products for paediatric use, orphan medicines, traditional herbal medicines, vaccines and clinical trials. In addition, once a medicinal product is placed on the market, its safety 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 governing medicinal products for human use in the EU
Legal framework

Medicines for Children
Medicines for Children

Orphan Medicines
Orphan Medicines

Advanced Therapies
Advanced Therapies

pharmaceutical Committee 
Pharmaceutical committee
and expert groups

Clinical Trials
Clinical Trials

Falsified medicines
Falsified medicines

Information to patients
Information to patients

Good Distribution Practice
Good Distribution Practice

Quality of medicines
Quality of medicines

Pharmacovigilance
Pharmacovigilance

 Traditional Herbal Medicines
Traditional Herbal Medicines

Personalised Medicine 
Personalised Medicine

Medicines and the Environment 
Medicines and the Environment

EU logo 
EU Logo for online sale of medicines

  Clinical Trials  
Radio-isotopes

50 Years
EU Pharmaceutical Legislation