The procedure for obtaining a marketing authorization (MA) in the European Union has become particularly complex. An applicant for a MA must indeed be acquainted with three different procedures: the national marketing authorization procedure; the mutual recognition procedure and the European Union marketing authorization procedure. In addition, one has to cope with the specific price and reimbursement procedures, which are still national no matter what procedure was followed in order to get a marketing authorization. Our firm has extensive experience in providing Pharmaceutical law legal advice to companies within the context of these proceedures as well as in the follow-up to these marketing authorizations, such as in pharmacovigilance.

In addition to our competence in the field of pharmaceutical law, our firm has developed a practice in the field of patients rights.

    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