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Medicinal products

  1. Lietuvių
  2. English

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 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

EU logo
EU Logo for
online sale of medicines

Good Manufacturing and Distribution Practices
Good Manufacturing and Distribution Practices

Pharmacovigilance
Pharmacovigilance

Traditional herbal medicines
Traditional herbal
medicines

Personalised medicine
Personalised medicine

Medicines and the environment
Medicines and
the environment

Call
Call for EMA committees
and board members

Call
Veterinary medicinal products

International cooperation on pharmaceuticals
International cooperation on pharmaceuticals