Legal support in public and corporate procurement in healthcare

Amendments to the registration documents of medical devices

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, government and corporate procurement, antitrust law, international trade law, regulatory issues, and compliance.

One of the key areas of legal services in the framework of the practice “Healthcare and Pharmaceuticals” of the BRACE Law Firm is legal support of public procurement in the health sector.

State and corporate procurement in the field of healthcare are regulated by the Federal Law of April 05, 2013 N 44-FZ “On the Contract System in the Sphere of Procurement of Goods, Works, and Services to Ensure State and Municipal Needs” and the Federal Law of July 18, 2011, N 223-ФЗО procurement of goods, works, services by certain types of legal entities”/

It should be noted the general tendency that procurements covered by the Federal Law of July 18, 2011 N 223-FZ have great variability in the choice of a customer’s behavior model, as they are regulated by the approved procurement regulation, while public procurements covered by the Federal Law from on April 05, 2013 N 44-FZ are clearly regulated by both this regulatory legal act and the additionally adopted legal acts of the Government of Russia and the Federal Antimonopoly Service of Russia.

Nevertheless, it is important to consider that at all stages of the procurement procedures, both the customer and the contractor must comply with a number of important requirements. Such requirements relate to the preparation of procurement documentation, determination of the initial (maximum) price of the contract, interaction with potential customers and the controlling authority in the field of procurement, compliance with anti-dumping measures, as well as the procedure for preparing and filing applications, concluding and further executing the contract, etc.

Legal services

    1. Legal advice on all legal issues arising from the procurement of medicines and medical devices
    2. Assistance in the development of procurement documentation of various types and focus
    3. Legal expertize of procurement documentation
    4. Legal assistance in the process of preparing requests for clarifications of procurement documents by potential procurement participants
    5. Legal support in contesting decisions on the inclusion of unscrupulous suppliers in the Register
    6. Legal support in appealing against the illegal actions of customers
    7. Legal advice to customers during inspections by the regulatory authority
    8. Legal representation in disputes arising from procurement in the field of healthcare

How do we work?

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Preliminary analysis and
initial consultation
Conclusion of legal services agreement
Project work
On each stage we inform you about results
We provide the result and prepared documents

Send us a request with a detailed description of the issue.

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