Pharmaceutical Law and Compliance
The Firm provides extensive, complex legal advice in all areas of pharmaceutical law by having an especially deep understanding and widespread expertise in this area due to the distinct and direct industry experience gained over the years.
The Firm is committed to represent domestic and international pharmaceutical clients
providing overall assistance related to commercial practices associated with prescription and OTC medicinal products, medical aids which are also qualified as medical devices towards lay third parties or healthcare professionals. In this context, the firm does not only elaborate the related agreements in accordance with the legal and ethical requirements, but also participates in the preparation and review of the printed and online marketing materials addressed to healthcare professionals, whilst assisting in the preparation of and providing expert opinion on promotional materials for OTC products being published on various media platforms. To the extent permitted by the legal environment, the Firm supports the implementation of influencer campaigns for certain health care products.
In trade and commercial practices,
the use of constantly evolving platform solutions (e.g. Facebook, Instagram, Apps, podcasts, etc.) represent increased challenges in ensuring compliance with legal and ethical requirements. The approval of different types of marketing materials requires comprehensive legal and ethical knowledge, whereby, in addition to pharmaceutical law, it is important to consider the provisions of advertising and competition law, the industrial ethical requirements, as well as the case law of Regulatory Authority and the Self-Regulating Advertising Board’s guidelines. With full knowledge of the Hungarian Competition Authority’s and the pharmaceutical authority’s case law, the Firm provides practical advice supporting the business in order to ensure the proper legal assessment of complex issues related to both advertising law and promotion of medicinal products.
The Firm has experience in the elaboration and review of the institution related, investigator related agreements, as well as the related supplementary agreements (study assistants, laboratory testing, monitoring contracts, etc.) associated with the conduct of clinical trials and non-interventional trials in Hungary. The Firm supports the development of patient support programs (PSP) in accordance with the legal and ethical requirements.
In the field of pharmaceutical wholesale, in accordance with the relevant international standards (GDP, GMP), the Firm provides adequate legal support in the course of the various negotiation processes, and the development of transport and storage contracts as well as in the course of the official procedure for obtaining a wholesale license.
The Firm also assists in the preparation of internal company regulations and standard operating procedures (policies, SOPs), furthermore undertakes to hold professional lectures and trainings related thereto.
The Office can also offer advice on the interpretation and implementation of the industrial AIPM Code of Practice and Code of Ethics for Pharmaceutical Marketing Communications and undertakes to develop the contractual framework with healthcare professionals and healthcare providers ensuring a lawful and ethical cooperation.
The Firm performs representation in proceedings in front of the pharmaceutical authority, the consumer protection authority and the Self-Regulating Advertising Board related to the advertising of medicinal products, as well as the competition supervision proceedings in front of the Hungarian Competition Authority.
Due to the dynamic change of this area of law, it is indispensable that the Firm shall constantly monitor and observe the changes in the legislation, furthermore it shall inform its Clients in connection with such changes accordingly. In each case, the Firm shall send an appropriate summary of the amendments to its Clients and, upon request, shall also assist in the implementation of the amendments. In this context, we stress the importance thereof, that the Firm participated in the procedure related to the preparation of the legislation in connection with the implementation of the Hungarian legal background of the so-called „compassionate use” as well as several amendments of the Medicine Distribution Act. Furthermore, the Firm participated in the amendment of the Code of Ethics for Pharmaceutical Marketing Communications in 2020 as well as the implementation of the EFPIA HCP Code in Hungary.
The Firm applies specialized expertise in the implementation of vaccine disease awareness campaigns and in complying with the legal and ethical obligations required at all stages of vaccine supply (eg. verification issues).