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.