Areas of Practice
Corporate & Labor
Mergers & Acquisitions
Antitrust & Regulatory
Compliance and Anticorruption
Dispute Resolution and Litigation
PSA Regime in Ukraine
Upstream Oil & Gas
Downstream / Project Finance
Finance / Banking / Capital Markets
Land & Construction
International Trade and Customs
The RULG - Ukrainian Legal Group (RULG) has extensive experience in regulatory compliance in the healthcare sector, advising on all matters relating to drugs and medical products including registration of medicines and medical products, their import, sale, storage, certification, licensing transactions with medicines, as well as price regulation of medicines and medical products. We participate fully with the European Business Association on issues related to healthcare, including the preparation of appeals to clarify and eliminate inconsistencies in existing legislation. We are also involved in:
We also offer similar advice on the regulatory treatment of cosmetic products.
- Monitoring and advising on legislation concerning the circulation of medicines and medical products.
- Development, legal analysis and support of contracts related to the handling of medicines and medical products and support of contracts for clinical research, formalizing arrangements with regards to international sponsors and local sponsors.
- Advising on matters relating to the conduct of clinical trials, including participating in the settlement of claims of patients who participated in clinical trials.
- Legal analysis and support contracts for voluntary health insurance companies and policyholders.
- Advising on customs clearance of medicines and medical products, including advising on Ukrainian legislation governing the VAT-exempt importation of medical products; participating in relevant disputes with customs bodies; preparing, filing and supporting requests to customs bodies related to the determination of the goods' code under the Ukrainian Classification of Goods of Foreign Economic Activity.
- Obtaining at the Ministry of Health of a one-time permit for importation into the customs territory of Ukraine of unregistered medical products in accordance with established procedure.
- Registration in the Customs Register of Objects of Intellectual Property of trademarks for medicines and medical products to prevent parallel importation of counterfeit imports.
- Advising on intellectual property rights in trademarks for medicines and medical products.
- Interaction with law enforcement agencies on matters related to violations in the field of healthcare, including in connection with illegal sales of pharmaceuticals.
- Preparing, filing and supporting on behalf of right-holders unfair competition and IP infringements applications with regulatory authorities, such as the Antimonopoly Committee of Ukraine, and court claims against intellectual property infringements and unfair competition with regards to medicines and medical products.
- Monitoring, on a weekly basis, legislation and regulations affecting the healthcare sector and reporting to the clients providing comments on new developments.
- Advising on laws and regulations applicable to public procurement of medicines and medical products.
- Advising on tax treatment of transactions with drugs and medical products, as well as related operations.
- Advising on and preparing, filing and supporting requests, claims to be filed with the drugs quality control bodies on various issues.
- Researching legislation and practice of the Antimonopoly Committee of Ukraine and courts on protection of economic competition in the sales of medicines and medical products, as well as providing related services, advising on relevant provisions in the distribution agreements and other contracts.
- Monitoring and advising on price control plans, measures and reimbursement schemes by the Government in the healthcare sector.
- Advising on registration of the Trademarks License Agreement and authorizing the use of certain trademarks.
- Carrying out due diligence of distributors of medicines and medical products and other counterparties, participating in negotiations and assisting with settlement of relevant disputes.
- Advising on labeling, including country of origin, the Ukrainian National system of certification and language, requirements for medicines and medical products, assisting with drafting labels or bringing existing labels into compliance with applicable laws of Ukraine.
- Assisting with the registration of medicines with the Ministry of Health of Ukraine.