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Pharmaceutical law

Our Firm has extensive experience in all areas pharmaceutical law, and we provide up-to-date legal advice to producers and wholesalers of pharmaceutical and medical devices as well as to healthcare service providers.

The Law Firm is the legal advisor in preparation of industry specific regulations and implementation of the multinational projects in Hungary. The lawyers in the Pharma praxis have substantial experience all areas, like advising on contracts in clinical trials and promotional, commercial practices, preparation of SOPs and bylaws, interpretation of regulatory and ethical compliance issues. The firm also supports and represents its its clients in preparation of their bids and contracts in public procurement procedures, and in distribution and warehousing agreements negotiation.

Recognising that promotion and advertising are one of the most sensitive and most heavily regulated areas of the distribution of pharmaceutical products, our lawyers strive to provide the most efficient services to our clients in these areas, including:
  • conducting due diligence and compliance reviews and developing action plans;
  • examining long term marketing strategies from a legal point of view;
  • advising on both promotional and professional events;
  • examining alternative promotional strategies from the legal point of view and participating in the development of such projects. review of adherence and patient support programmes from compliance perspective.

The pharmaceutical law is closely connected to the ethical and compliance requirements, and the lawful and ethical cooperation with the healthcare professionals has increasing importance, therefore our Firm puts emphasis on the legal and ethical advices that are needed to develop the proper contractual terms and approval processes. The frequently changing regulatory environment and practices makes extremely important to have a solid legal background.

The permanently developing Information technology gives broad opportunities to diversified pharmaceutical marketing activities like on Facebook or iPad etc. but strong legal support is needed in order to keep the legal compliance requirements in such daily promotional activities.

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