EBA discusses the implementation of the new regulatory model with the State Expert Centre

22/ 07/ 2026

Representatives of the European Business Associations Health Care Committee took part in an open dialogue organised by the State Expert Centre of the Ministry of Health of Ukraine with the business community. The meeting focused on the practical aspects of implementing the new regulatory model for medicinal products. It provided a platform to discuss the key stages of implementing Law of Ukraine No. 2469-IX On Medicinal Products, which will enter into force at the beginning of 2027, as well as its transitional provisions. During the meeting, experts from the State Expert Centre provided clarifications on the implementation of the new regulatory requirements, including the application of the Laws transitional provisions, the phased introduction of new procedures, the operation of electronic services, the implementation of the electronic Common Technical Document (eCTD) format for submitting registration dossiers, and the markets preparation for operating under the new regulatory framework. Participants also focused on issues of particular importance to the pharmaceutical industry. Company representatives raised questions regarding the practical application of the Laws transitional provisions, the adequacy of the transition periods for adapting to the new requirements, the continuity of regulatory procedures, the readiness of electronic systems to support the new framework, and the specifics of the transition to the eCTD format for registration dossiers. A significant part of the discussion centred on identifying solutions that would ensure a predictable transition to the new regulatory model without disrupting patients continuous access to medicinal products. The Association thanks the State Expert Centre of the Ministry of Health of Ukraine for its openness to dialogue and for organising the meeting. At the same time, a number of the issues discussed remain a matter of concern for the business community, and the Association looks forward to continuing a constructive dialogue to identify balanced solutions. The Committee will continue to actively engage with public authorities and contribute to shaping a regulatory environment that is aligned with European approaches, provides legal certainty for businesses, and ensures uninterrupted patient access to modern medicinal products.

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Representatives of the European Business Association’s Health Care Committee took part in an open dialogue organised by the State Expert Centre of the Ministry of Health of Ukraine with the business community. The meeting focused on the practical aspects of implementing the new regulatory model for medicinal products. It provided a platform to discuss the key stages of implementing Law of Ukraine No. 2469-IX “On Medicinal Products”, which will enter into force at the beginning of 2027, as well as its transitional provisions.

During the meeting, experts from the State Expert Centre provided clarifications on the implementation of the new regulatory requirements, including the application of the Law’s transitional provisions, the phased introduction of new procedures, the operation of electronic services, the implementation of the electronic Common Technical Document (eCTD) format for submitting registration dossiers, and the market’s preparation for operating under the new regulatory framework.

Participants also focused on issues of particular importance to the pharmaceutical industry. Company representatives raised questions regarding the practical application of the Law’s transitional provisions, the adequacy of the transition periods for adapting to the new requirements, the continuity of regulatory procedures, the readiness of electronic systems to support the new framework, and the specifics of the transition to the eCTD format for registration dossiers. A significant part of the discussion centred on identifying solutions that would ensure a predictable transition to the new regulatory model without disrupting patients’ continuous access to medicinal products.

The Association thanks the State Expert Centre of the Ministry of Health of Ukraine for its openness to dialogue and for organising the meeting. At the same time, a number of the issues discussed remain a matter of concern for the business community, and the Association looks forward to continuing a constructive dialogue to identify balanced solutions. The Committee will continue to actively engage with public authorities and contribute to shaping a regulatory environment that is aligned with European approaches, provides legal certainty for businesses, and ensures uninterrupted patient access to modern medicinal products.