Best Lawyers for Health Care Law in Moscow, Russia

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Lawyer
  • Recognized Since: 2020
  • Location:
    Moscow, Russia
  • Practice Areas:
    Health Care Law Life Sciences Practice
Lawyer
  • Recognized Since: 2022
  • Location:
    Moscow, Russia
  • Practice Areas:
    Health Care Law

  • Recognized Since: Ones to Watch Since:
  • Location:
  • Practice Areas:

Recognition by Best Lawyers is based entirely on peer review. Our methodology is designed to capture, as accurately as possible, the consensus opinion of leading lawyers about the professional abilities of their colleagues within the same geographical area and legal practice area.

Best Lawyers employs a sophisticated, conscientious, rational, and transparent survey process designed to elicit meaningful and substantive evaluations of the quality of legal services. Our belief has always been that the quality of a peer review survey is directly related to the quality of the voters.

Practice Area Definition

Health Care Law Definition

The health care sector counts as one of the most regulated sectors in Russia. In the same time, it is also one of sectors with remarkable competition between the manufacturing companies.

Public authorities regulate the sector in several ways: by mandatory registration procedure for all drugs and medical devices; by licensing the manufacturing, wholesale, and retail; by regulation of price rates. Additionally, some indirect regulation mechanisms are also very well tuned and applied in Russia – e.g. public procurements (with limitation of access for foreign companies), restrictions in marketing activities for promotion of health care products (advertising, interactions with HCPs, etc.)

The health care sector in Russia remains well the most sensible sector in terms of compliance. In this sense, one of the special features for Russia is the stance of anti-monopoly authorities towards compliance practices of health care companies – so that we recommend our clients to choose formalistic and consequent approach to compliance issues in order to minimize the anti-monopoly risks.  

As one of the recent regulatory novelties for Russia, mandatory GMP certification should be mentioned. In particular, this applies to foreign manufacturing sites which have to undergo the Russian GMP inspection in order to remain eligible importing products to Russia.  

The nearest perspective for the sector is commencement of the Unified Eurasian market operation. The unified Eurasian market for drugs and medical devices has emerged in 2016, will become operative some months later. The new regulations for market authorizations, as well as for GMP certification will become applicable for companies operating on the territory of the Eurasian Union.  

Another area of law affecting significantly the health care sector is the intellectual property law. Apart from the regulation of particular IP assets, such patents, trademarks etc. and related litigation, one concept that has recently emerged is data protection.  It is aimed at protecting clinical research data contained in the registration dossier of drugs at the ministry of health and prevents it for being used for registration of generic products for a certain period of time (up to 6 months). 

Lidings

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The health care sector counts as one of the most regulated sectors in Russia. In the same time, it is also one of sectors with remarkable competition between the manufacturing companies.

Public authorities regulate the sector in several ways: by mandatory registration procedure for all drugs and medical devices; by licensing the manufacturing, wholesale, and retail; by regulation of price rates. Additionally, some indirect regulation mechanisms are also very well tuned and applied in Russia – e.g. public procurements (with limitation of access for foreign companies), restrictions in marketing activities for promotion of health care products (advertising, interactions with HCPs, etc.)

The health care sector in Russia remains well the most sensible sector in terms of compliance. In this sense, one of the special features for Russia is the stance of anti-monopoly authorities towards compliance practices of health care companies – so that we recommend our clients to choose formalistic and consequent approach to compliance issues in order to minimize the anti-monopoly risks.  

As one of the recent regulatory novelties for Russia, mandatory GMP certification should be mentioned. In particular, this applies to foreign manufacturing sites which have to undergo the Russian GMP inspection in order to remain eligible importing products to Russia.  

The nearest perspective for the sector is commencement of the Unified Eurasian market operation. The unified Eurasian market for drugs and medical devices has emerged in 2016, will become operative some months later. The new regulations for market authorizations, as well as for GMP certification will become applicable for companies operating on the territory of the Eurasian Union.  

Another area of law affecting significantly the health care sector is the intellectual property law. Apart from the regulation of particular IP assets, such patents, trademarks etc. and related litigation, one concept that has recently emerged is data protection.  It is aimed at protecting clinical research data contained in the registration dossier of drugs at the ministry of health and prevents it for being used for registration of generic products for a certain period of time (up to 6 months).