We provide legal assistance in the area of pharmaceutical regulatory law, starting with matters relating to clinical trials, authorization of products, as well as the carrying out of commercial practices, and matters relating to the cooperation with healthcare professionals and healthcare organizations. We support our clients in fully meeting applicable legal requirements as well as the requirements of the authority, and also provide assistance in the course of investigations by the authority. Additionally, we provide legal advice in matters concerning the reimbursement of pharmaceutical products, the admission of pharmaceutical products into the social reimbursement system, the conclusion of price volume agreements, and the related payment obligations, as well as in food law matters, including the notification of food supplements and other categories of food.
Our practice group headed by Annamaria Klara also provides legal advice in the areas of public procurement law, competition law as well as contract law in relation to the pharmaceutical industry, where our experts bring indispensable pharmaceutical law knowledge and experience to these related areas. We therefore also provide legal advice in the course of procurements of pharmaceutical products as well as the conclusion of distribution agreements, including compliance of such agreements with competition law requirements, and also represent our clients in litigations and authority investigations.
References
- We advised the Hungarian subsidiary of an international pharmaceutical company in the course of the investigation conducted by the national competent pharmaceutical authority;
- Advised the Hungarian subsidiaries of several international groups of companies in connection with their merger and transfer of business units;
- Provided legal advice in legal remedy procedures in public procurement procedures of pharmaceutical products;
- We assisted our clients in the course of the introduction of the safety features appearing on the packaging of medicinal products;
- We regularly advise pharma clients in public procurement procedures for the procurement of their products; we provided legal representation in a series of high profile medicinal product liability litigations;
- We represented several innovative pharmaceutical manufacturers in administrative litigations relating to the regulatory data protection of their products.
