Healthcare industries, Life sciences and Pharmaceuticals

The GOLAW team provides a full range of legal assistance to pharmaceutical and medical companies in Ukraine — manufacturers, distributors and suppliers of medicines, medical devices and equipment, healthcare facilities, as well as public and charitable organisations in the healthcare sector.

Legal support in the healthcare and pharmaceutical market covers a comprehensive range of matters related to regulatory requirements for the circulation of medicines, medical devices, cosmetic products and the operation of healthcare facilities: licensing, product registration, pharmacovigilance compliance, support of clinical trials, participation in public procurement and reimbursement programmes, as well as pricing and competition matters.

The market operates under strict regulatory control, so any violation or non-compliance with the established requirements may result in refusal of product registration, suspension of its circulation, imposition of fines, supply restrictions or reputational damage.

GOLAW lawyers are engaged both at the stage of launching a business or bringing a product to the Ukrainian market, and in the course of day-to-day operations — during inspections by regulatory authorities and in public procurement disputes. We protect our clients’ interests in dealings with the Ministry of Health, the State Expert Center, the National Health Service of Ukraine, the State Service on Medicines and Drugs Control, the Antimonopoly Committee of Ukraine, customs authorities and other state institutions, support contractual relations with research centres, healthcare facilities, distributors and partners, and have extensive experience in supporting the import of specialised medical and diagnostic equipment.

Our proactive approach allows us to minimise regulatory risks, ensure compliance with legislative requirements and maintain the continuity of medical business operations.

Key areas of work:

• Legal support of licensing of medical practice, pharmaceutical manufacturing, wholesale and retail trade in medicines, as well as import of pharmaceutical products
• Legal support of registration of medicines, medical devices and cosmetic products
• Legal support of clinical trials and contractual work with research centres and healthcare facilities
• Legal support on pharmacovigilance and product safety matters, preparation for inspections and challenging their results
• Legal support of participation in public procurement and reimbursement programmes, preparation of tender documentation and challenging procurement results
• Support on state price regulation matters in the pharmaceutical and medical products sector
• Antitrust support and protection of clients’ interests, as well as legal support on patent and intellectual property matters
• Confirmation of compliance with GMP requirements and support of import and export of medicines and medical devices