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.
Medicinal Products for Veterinary Use
Medicinal products for veterinary use, like medicinal products for human use, have to be authorised either at Member State or Community level before they can be placed on the Medicinal products for veterinary use, like medicinal products for human use, have to be authorised either at Member State or Community level before they can be placed on the European Union.
The first objective of the European legislation is to protect public and animal health. The second objective is the completion of the internal market for pharmaceutical products. Particular special rules are applied to ensure consumer protection from residue limits from pharmacologically active substances used in food-producing animals.
The Commission is considering a revision of the legal framework for veterinary medicinal products.
As international markets expand and companies operate more and more internationally, the task of regulatory authorities to assess compliance with legislation and monitor the safety of medicines becomes increasingly difficult and resource-intensive. In response to this overall situation and to address the challenges of globalisation, which can pose potential risks to public health, the European Commission has intensified global cooperation on different levels.
International cooperation in the pharmaceutical sector takes the form of :
Relations with European and international organisations;
Relations with third countries.
Further information on activities in the pharmaceutical sector related to the European Union’s enlargement is available on the EMA website
EMA European Medicines Agency
The European Medicines Agency is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. It began operating in 1995.