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Pharmaceutical Law


The regulation of the pharmaceutical sector has been tangibly strengthened over the recent decades, introducing a number of requirements to the manufacturing, advertising and distribution of pharmaceutical products and especially the conduct of clinical trials. The Bulgarian legislation in this sphere is in line with the development of European regulations and it is in the process of continuous adjustment.

The specific features of the pharmaceutical business require experience and knowledge not only in legal matters but also in the authorization techniques for the use, advertising and sale of pharmaceutical products and active substances and the related specific contractual relations, as well as the problems which business entities confront in practice. This knowledge should cover all phases of a clinical trial and the specific issues which might occur at each stage.

For the last few years, the PM&P team has acquired substantial experience in pharmaceutical law, providing advice on various authorization arrangements, including the registration of prices, the trade in pharmaceutical products, and the requirements to clinical trials.

Landmarks in the track record of PM&P are the participation in the first of its kind restructuring of a multinational pharma company with the implementation of a new business model for the distribution of pharmaceutical products; the market withdrawal of an imitation drug infringing upon the intellectual property rights of the manufacturer Bayer AD in connection with its trademark ASPIRIN; the representation of a manufacturer of medical devices before hospitals and patients, including the cases of explantation; the legal representation in disputes between use authorization holders and local manufacturers; the legal defense against customs authorities for the reversal of an excise tax assessment of a drug and others.

The team of the law firm also has rich experience in the preparation of agreements on the distribution, the sale of a drug file, registration, advertising, promotion of drugs and others. Furthermore, PM&P provides overall support to the negotiating of such agreements.

PM&P provides legal advice and assistance to local and foreign companies in the distribution of food additives and cosmetic products which have greatly expanded their market presence for the last few years.

 

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Comments:

“Penkov, Markov & Partners act for both domestic and international clients, and Lega InterConsult has a strong German language practice, advising clients from Germany, Austria and Switzerland.“
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