The EU pharmaceutical legal framework is based on two main pieces of legislation: Directive 2001/83 on the community code relating to medicinal products for human use and Regulation 726/2004 establishing European procedures for the authorization and supervision of medicinal products for human and veterinary use. This Regulation establishes the European Medicines Agency (EMA) based in London.
In addition to these two pieces of legislation, there is a whole range of more specific laws, such as the legislation on clinical trials or non-binding instruments such as the Commission “Communication on parallel imports of proprietary medicinal products for which marketing authorisations have already been granted”.
Our firm has extensive experience in advising companies that manufacture pharmaceutical products
In addition to pharmaceutical law, our firm has also developed a practice in the field of :