Our lawyers have acquired recognized expertise in the field of pharmaceutical law, the complexity of which stems from the intersection of legal issues pertaining to a variety of more traditional areas of law: regulatory law, intellectual property law, contract and property law, taxation law, and many others.
⦁ advising clients on the regulatory aspects of the authorization of medicines, as well as handling of relations with the National Medicines Agency;
⦁ advising clients on the regulatory aspects of the authorization of medicines, as well as handling of relations with the National Medicines Agency;
⦁ advising clients on issues related to the pricing of medicines, including reimbursement and handling of relations with the Ministry of Health and the National Health Insurance House;
⦁ drafting or legal review of protocols executed by clients from the pharmaceutical industry with the competent state authorities, regarding the supply of medicinal products for patient healthcare in Romania;
⦁ advising clients in negotiations with the National Medicines Agency with respect to the legal framework for regulatory data protection for the results of clinical studies / market exclusivity;
⦁ advising and representing clients on issues related to the special taxation levied on the pharmaceutical industry (claw-back), including challenging decisions of the competent state entities;
⦁ advising and assisting clients from the pharmaceutical sector on the protection of their IP rights (patents, trademarks etc.) and on the relation between the IP rights and the pharma regulations.