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Healthcare and Pharmaceutical Market

Comprehensive legal support in the healthcare and pharmaceutical market: regulatory compliance, licensing and product registrations, clinical trial support, pharmacovigilance, public procurement, pricing, antitrust, and intellectual property matters.

Legal support for pharmaceutical and biotechnology companies, manufacturers and distributors of medical devices and cosmetic products, clinical trial sponsors, private healthcare providers, HealthTech/MedTech start-ups, as well as investors and top management in the healthcare sector.

What Constitutes Legal Support in This Area

Legal support in the healthcare and pharmaceutical markets covers a range of matters related to regulatory requirements for the circulation of medicinal products, medical devices, and cosmetic products, as well as the operation of healthcare institutions.

Such support includes licensing, product registration, ensuring compliance with pharmacovigilance requirements, organising clinical trials, participating in public procurement and reimbursement programmes, as well as pricing and competition matters.

The healthcare and pharmaceutical market operates under strict regulatory control; therefore, any violations or non-compliance with established requirements may result in refusal of product registration, suspension of its circulation, imposition of fines, restriction of supply, or reputational damage.

GOLAW lawyers are engaged both at the stage of business launch or product entry into the Ukrainian market, and within the ongoing operational activities of companies, during inspections by regulatory authorities, and in disputes in the field of public procurement.

We ensure the protection of clients’ interests in interactions with the Ministry of Health of Ukraine, the State Expert Centre, the National Health Service of Ukraine, the State Service of Ukraine on Medicines and Drugs Control, the Antimonopoly Committee of Ukraine, customs authorities and other state institutions, as well as support contractual relations with research centres, healthcare institutions, distributors and partners.

Our proactive approach allows minimisation of regulatory risks, ensuring compliance with legal requirements and maintaining the continuity of medical business operations in the market.

Our Services Include

  • Legal support of licensing of medical practice, pharmaceutical manufacturing, wholesale and retail trade in medicinal products, as well as import of pharmaceutical products
  • Legal support of registration of medicinal products, medical devices, and cosmetic products
  • Legal support of clinical trials and contractual work with research centres and healthcare institutions
  • Legal support of 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 for state regulation of prices in the pharmaceutical and medical products sector
  • Antitrust support and protection of clients’ interests, as well as legal support on patents and intellectual property rights

What Legal Support of a Project Encompasses

1
1
Initial legal analysis and strategy development
Assessment of the client’s request, analysis of the regulatory environment, and determination of the optimal format of legal support, taking into account business objectives and potential risks
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2
Preparation and approval of supporting documentation
Preparation and legal review of documents required for project implementation, as well as their approval with the client
3
3
Support of interaction with involved parties
Legal support of communication and negotiations with counterparties and partners, as well as support of interaction with state authorities and response to requests and comments
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4
Support of regulatory procedures and submission of documents
Legal support of the implementation of agreed actions, including the submission of documents, support of the review of materials, and coordination of compliance with procedural requirements until the result is obtained
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5
Project completion and formalisation of results
Support of final stages of the project, preparation of final documents and materials, and formalisation of project results in accordance with the agreed scope of work

Key lawyers

Sergii Oberkovych
Sergii Oberkovych
  • Managing Partner at GOLAW, Attorney at law
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Contact
Linkedin
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Oleksandr Melnyk
Oleksandr Melnyk
  • Partner, Head of Corporate Law and M&A practice, Attorney at law
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Contact
Linkedin PDF

We are trusted

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Frequently asked questions

  • Which organisational and legal model should be chosen for entering the Ukrainian market?

    The choice of presence model affects the tax burden, the entity’s legal status, the ability to carry out certain activities, and the specifics of interaction with state authorities. At the same time, it is important to consider that a representative office is not a separate legal entity and cannot obtain licences, which significantly limits the ability to conduct activities in the pharmaceutical and medical sectors. An incorrectly chosen business structure may lead to operational limitations and additional regulatory and tax risks.

  • What key regulatory requirements should be taken into account when opening a pharmacy in Ukraine?

    Obtaining a licence for retail trade in medicinal products requires compliance with clearly defined requirements for premises, personnel, equipment, and documentation of activities. Non-compliance with even one of the criteria may serve as grounds for refusal to issue a licence or delay the launch of the business.

  • What conformity assessment requirements apply to medical devices and personal protective equipment before they are placed on the market in Ukraine?

    Placing such products on the market is only possible after completing the conformity assessment procedures required by technical regulations. Incorrectly identifying the applicable technical regulation or conformity assessment procedure can lead to restrictions or prohibition of placing products on product placement, the implementation of state supervision (control) measures, and complications in market access.

  • Are antitrust risks relevant for pharmaceutical companies, distributors of medicinal products, and other participants in the pharmaceutical market that do not hold a dominant position?

    Antitrust risks in the pharmaceutical sector may arise not only for companies with a dominant position, but also for manufacturers, importers, distributors, and pharmacy chains. In particular, the Antimonopoly Committee of Ukraine pays increased attention to exclusivity conditions, bonus and discount models, marketing agreements, as well as approaches to the pricing of medicinal products. Prior legal analysis of contractual and commercial practices allows minimisation of risks of violation of competition law and application of enforcement measures by the Antimonopoly Committee of Ukraine.

Get in touch

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+380 44 581 1220
+380 44 581 1220

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