Legal advice on the circulation of medicines, medical devices, dietary supplements

BRACE Law Firm within the practice “Healthcare and Pharmaceuticals” provides legal services to manufacturers and distributors of medicines, medical devices, dietary supplements, and other healthcare organizations on issues of Russian and international law. We provide legal assistance in the areas of business support, dispute resolution and litigation, public and corporate procurement, antitrust law, international trade law and foreign investments, and real estate issues.

One of the important areas of legal services in the framework of the practice “Healthcare and Pharmaceuticals” of BRACE Law Firm is legal advising on the circulation of medicines, medical devices, dietary supplements.

Legal issues in the circulation of medicines, medical devices, dietary supplements

The legal regulation of the circulation of medicines, medical devices and dietary supplements are regulated by a fairly large number of special legal norms. Such regulation applies to the specifics of importing drugs into the territory of Russia, conducting preclinical and clinical trials, monitoring safety, conducting state registration and further promotion of drugs and medical devices, establishing a pricing policy and developing internal guidelines for pharmaceutical companies on the basis of which they operate and form the basis for compliance with both legal and ethical standards. Besides, significant features have requirements for the implementation of wholesale and retail trade in medicines. Special attention deserves the need to take into account the characteristics of the treatment of dietary supplements.

It is important to note that under companies involved in the circulation of medicines, medical devices, dietary supplements in the Russian Federation, control is carried out by authorized bodies. At the same time, a competently structured legal position during inspections by regulatory authorities significantly increases the ability to avoid being held accountable and/or to minimize penalties if any violations have been identified.

The above and other features of the legal regulation of the circulation of medicines, medical products, and dietary supplements require practical experience in legal support of the activities of manufacturers and distributors of this type of goods.

Legal services

1. Legal support of pharmaceutical companies
2. Legal support for manufacturers and distributors of medical devices
3. Legal advice on the circulation of drugs, medical devices, dietary supplements
4. Legal support in public procurement in healthcare
5. Development and legal expertize of contracts (in the implementation of pharmaceutical activities and activities in the field of circulation of medical devices)
6. Development and legal examination of internal policies (anti-corruption, antitrust, and others) for pharmaceutical companies and companies in the field of medical products
7. Legal advice on the protection of personal data in healthcare
8. Legal support for the promotion of drugs, medical devices, dietary supplements
9. Legal advice during inspections (pharmaceutical organizations and companies in the field of circulation of medical devices)
10. Protection of interests from the unfair competition (in the field of pharmaceutical activity (pharmaceutical organizations and companies in the field of circulation of medical devices)
11. Advice on the formation of lists of medicines
12. Advice on state registration and re-registration of drug prices
13. Preparation of draft licensing agreements and agreements on the alienation of exclusive rights
14. Registration of medical devices and amendments to registration documents of medical devices