Representation of Marketing Authorisation Holders in Ukraine

We are pleased to announce the expansion of Bioscience Group’s service portfolio. From now on, Bioscience Group provides local representation for foreign marketing authorisation holders of medicinal products in Ukraine and helps coordinate their interactions with Ukrainian regulatory authorities in accordance with applicable legal requirements.

The introduction of this service is driven by the entry into force of the Law of Ukraine “On Medicinal Products” No. 2469-IX on 1 January 2027, which establishes new requirements for marketing authorisation holders.

In particular, marketing authorisation holders established in EU and EFTA countries that are not registered in Ukraine are now required to appoint a representative in Ukraine.

The local representative is intended to represent their interests before Ukrainian regulatory authorities and fulfil the obligations assigned to them by law, enabling foreign companies to properly meet Ukraine’s regulatory requirements concerning their medicinal products.

We help establish this formal representation and ensure that the agreed functions of the representative are carried out in accordance with Ukrainian legislation.

What Does Bioscience Group’s Local Representation Service in Ukraine Include?

• Representation of Interests in Ukraine. We represent the interests of marketing authorisation holders on the basis of an agreement and within the agreed scope of responsibilities.
• Communication with Regulatory Authorities. We facilitate interaction with the competent Ukrainian authorities on matters falling within the representative’s remit.
• Pharmacovigilance Coordination. We help coordinate interaction between the marketing authorisation holder and the representative regarding relevant pharmacovigilance responsibilities and procedures in Ukraine.
• Support with Labelling and Packaging Requirements. We help address requirements concerning the inclusion of the representative’s details on medicinal product packaging and/or in the package leaflet, where required by applicable regulations.
• Administrative Support. We coordinate organisational matters related to the performance of the local representative’s functions within the agreed scope of services.

Why Choose Bioscience Group?

• Flexible Cooperation Model. Local representation for a single medicinal product or an entire product portfolio.
• Expertise in the Ukrainian Regulatory Environment. We understand Ukrainian regulatory requirements for medicinal products and work with them on a daily basis. Bioscience Group has many years of experience in the Ukrainian pharmaceutical market and extensive experience supporting numerous clients in addressing regulatory challenges across the pharmaceutical industry.
• A Single Point of Contact. One partner for representation in Ukraine and communication with regulatory authorities.

Contact Bioscience Group to discuss your medicinal product portfolio, identify the applicable requirements and agree on the appropriate representation model in Ukraine. Prepare for the new requirements in advance.

Discuss Cooperation:

Email: [email protected]

Phone: +38 (050) 463 82 66