Humánní léčivé přípravky
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.