droit pharmaceutique


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 :

    Based in Brussels and Paris, the law firm Laffineur mainly advises companies with regard to the various legal issues that may arise for them at the transnational level. The firm develops expertise in the field of regulatory law for the internal market of the European Union. The Firm also works in international trade law, lobbying, business law, liability law as well as in the field of European, Belgian and French litigation.
    BRUSSELS : C/O AVOCAP Bruxelles Boulevard Saint-Michel 11, 1040 Etterbeek - Belgique
    PARIS : 222 Boulevard Saint Germain 75007 Paris - France
    BRUSSELS :+32 (0) 23 06 48 58
    PARIS : +33 (0) 1 42 60 04 31