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European Commission - Statement

Commissioner Andriukaitis hails half a century of European pharmaceutical legislation

Brussels, 30 January 2015

This year marks the 50th anniversary of the birth of pharmaceutical legislation in the EU. On 26 January 1965 the Council Directive 65/65 on the approximation of the law relating to medicinal products was adopted. That was the first piece of EU pharmaceutical legislation introducing some founding principles that are valid until today.

Around those principles a large body of legislation has been developed over the last 50 years in order to guarantee high standards of quality, safety and efficacy for medicinal products. Medicines authorised in the EU are of the highest quality and undergo a detailed assessment regarding their benefits and risk before being placed on the market.

European pharmaceutical legislation has throughout the years resulted in one of the safest and most advanced systems for monitoring the safety, quality and efficacy of medicines while at the same time supporting and promoting research and innovation. It is a shining example of the value-added the European Union brings into our daily lives.

The EU pharmaceutical sector is one of Europe's most important economic sectors employing 1.8% of the total manufacturing workforce. It is also a main employer in R&D terms, employing over 110,000 people. The EU was the world’s biggest trader in medicinal and pharmaceutical products in 2013, with total trade amounting to € 156.9 billion (EU28) and value of exports reaching more than € 107.4 billion.

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Read also the factsheet published on the subject.


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