EBA submits proposals to the Ministry of Health’s draft order on clinical trials

01/ 07/ 2026

The European Business Association has submitted its proposals to the Ministry of Health of Ukraine regarding the draft Order Certain Issues Related to the Import into the Customs Territory of Ukraine, Accounting, Storage, Use, Destruction, Disposal or Export from the Customs Territory of Ukraine of Investigational Medicinal Products, published for public consultation on 2 June 2026. The business community welcomes the development of the draft Order as an important step towards implementing the provisions of the Law of Ukraine On Medicinal Products No. 2469-IX and further harmonising Ukrainian legislation with EU law. Following a detailed review of the draft, the Associations experts have prepared a number of comments and proposals aimed at improving the document and ensuring its consistency with the current legal framework and European practice. The Associations key proposals include: Expanding the scope of regulation The Association supports extending the requirements not only to investigational and auxiliary medicinal products, but also to concomitant medications, diluents, medical devices, equipment and other technical means (ancillary products) used in clinical trials, in order to ensure comprehensive regulation of the entire clinical trial infrastructure. Clearly establishing the non-commercial nature of operations The Association emphasises the need to explicitly define the research (non-commercial) nature of operations involving medicinal products and ancillary products. This is essential to avoid ambiguous interpretation, particularly by customs and tax authorities. Eliminating regulatory duplication The Association proposes avoiding the repetition of provisions already contained in Law No. 2469-IX, licensing requirements and Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards. Instead, it recommends adopting a cross-reference approach to prevent legal inconsistencies and unnecessary regulatory burden. Ensuring the continuity of clinical trials The Association supports clarifying the application of the transitional period until 1 January 2028, which allows investigational medicinal products to be imported by a sponsor or an authorised representative in accordance with the Law. Harmonisation with EU regulation Particular attention is given to aligning the draft with EU Regulation No. 536/2014 and current international practices, including global clinical trial supply chains. In the view of the business community, revising the draft Order in line with these proposals would improve the transparency and predictability of regulatory procedures, eliminate legal inconsistencies, and enhance Ukraines attractiveness as a destination for clinical research investment. At the same time, a number of provisions of the draft require further clarification, as their implementation without appropriate revision could create practical challenges for the conduct of clinical trials, particularly with regard to supply chain organisation, sponsors obligations, and the functioning of regulatory mechanisms. Therefore, the Association believes that the draft should undergo further revision with the involvement of representatives of the professional community to ensure that the key comments are duly considered and that the clinical trials framework operates effectively and without disruption. The Association reaffirms its readiness to continue a constructive dialogue with the Ministry of Health in order to develop an effective, balanced and EU-harmonised regulatory framework for clinical trials.

The European Business Association has submitted its proposals to the Ministry of Health of Ukraine regarding the draft Order “Certain Issues Related to the Import into the Customs Territory of Ukraine, Accounting, Storage, Use, Destruction, Disposal or Export from the Customs Territory of Ukraine of Investigational Medicinal Products”, published for public consultation on 2 June 2026.

The business community welcomes the development of the draft Order as an important step towards implementing the provisions of the Law of Ukraine “On Medicinal Products” No. 2469-IX and further harmonising Ukrainian legislation with EU law.

Following a detailed review of the draft, the Association’s experts have prepared a number of comments and proposals aimed at improving the document and ensuring its consistency with the current legal framework and European practice.

The Association’s key proposals include:

Expanding the scope of regulation

The Association supports extending the requirements not only to investigational and auxiliary medicinal products, but also to concomitant medications, diluents, medical devices, equipment and other technical means (ancillary products) used in clinical trials, in order to ensure comprehensive regulation of the entire clinical trial infrastructure.
Clearly establishing the non-commercial nature of operations

The Association emphasises the need to explicitly define the research (non-commercial) nature of operations involving medicinal products and ancillary products. This is essential to avoid ambiguous interpretation, particularly by customs and tax authorities.
Eliminating regulatory duplication

The Association proposes avoiding the repetition of provisions already contained in Law No. 2469-IX, licensing requirements and Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards. Instead, it recommends adopting a cross-reference approach to prevent legal inconsistencies and unnecessary regulatory burden.
Ensuring the continuity of clinical trials

The Association supports clarifying the application of the transitional period until 1 January 2028, which allows investigational medicinal products to be imported by a sponsor or an authorised representative in accordance with the Law.
Harmonisation with EU regulation

Particular attention is given to aligning the draft with EU Regulation No. 536/2014 and current international practices, including global clinical trial supply chains.

In the view of the business community, revising the draft Order in line with these proposals would improve the transparency and predictability of regulatory procedures, eliminate legal inconsistencies, and enhance Ukraine’s attractiveness as a destination for clinical research investment.

At the same time, a number of provisions of the draft require further clarification, as their implementation without appropriate revision could create practical challenges for the conduct of clinical trials, particularly with regard to supply chain organisation, sponsors’ obligations, and the functioning of regulatory mechanisms. Therefore, the Association believes that the draft should undergo further revision with the involvement of representatives of the professional community to ensure that the key comments are duly considered and that the clinical trials framework operates effectively and without disruption.

The Association reaffirms its readiness to continue a constructive dialogue with the Ministry of Health in order to develop an effective, balanced and EU-harmonised regulatory framework for clinical trials.