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Public Health
News announcement30 January 2015Directorate-General for Health and Food Safety3 min read

2015 marks the 50th anniversary of pharmaceutical legislation in the EU

2015 marks the 50th anniversary of pharmaceutical legislation in the EU

2015 marks the 50th anniversary of the adoption of the first law on the authorisation of pharmaceuticals at EU level, which set the basis for some of the key principles that are still valid today.

Much of the impetus behind the adoption of the first law on pharmaceuticals at EU level stemmed from the determination to prevent a recurrence of the thalidomide disaster of the late 1950s early 1960s, when thousands of babies were born with limb deformities as a result of their mothers taking thalidomide as a sedative during pregnancy. This experience, which shook public health authorities and the general public, made it clear that to safeguard public health, no medicinal product must ever again be marketed without prior authorisation. Over the past 50 years a large body of legislation has been developed around this principle, with the progressive harmonisation of requirements for the granting of marketing authorisations and post-marketing monitoring implemented across the entire EU.

To mark the 50th anniversary of the adoption of the first EU pharmaceutical law the European Commission is organising a one-day conference that will take place in Brussels on 28 September 2015. The conference will review past achievements while focusing on the present and future role of EU pharmaceutical legislation in protecting the health of citizens in the EU and in the world, and in promoting advances in science, innovation and public health. Despite the many achievements there are still many challenges ahead. Different stakeholders see these challenges but each from different perspectives. The conference wants to bring to surface these different perspectives in an open and stimulating exchange with representatives from national governments, European institutions, national competent authorities, industry, healthcare professionals, academia and patient groups, with the objective of working towards a shared vision for the future.

Additional information:

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.

Details

Publication date
30 January 2015
Author
Directorate-General for Health and Food Safety