The Center hosted an open online meeting with representatives of the pharmaceutical market regarding the choice of a reference medicinal product after the entry into force of the new Law of Ukraine "On Medicinal Products" No. 2469-IX.
The event was attended by representatives of the administration and heads of the departments of registration materials and of bioavailability and equivalence assessment. More than 100 representatives of pharmaceutical companies and the professional community joined the online discussion.
During the meeting, the Director of the Department of Bioavailability and Equivalence Assessment of the Center, Nadiia Zhukova provided practical clarifications on the new approaches to determining the reference medicinal product, which will begin to be applied from 1 January 2027.
In particular, it was emphasized that, in accordance with the new law, a reference medicinal product must be registered under a full registration dossier in Ukraine or, in its absence, by a competent authority of the European Union or an EU member state.
The new approach is based on the provisions of European legislation, in particular Directive 2001/83/EU and the implementing act, according to which the reference medicinal product must be:
- registered under a full registration dossier;
- be part of the main licence for the reference medicinal product, including its additional doses, pharmaceutical forms, routes of administration, and labelling, which were made as variations to the registration dossier or variations requiring a new registration.
Therefore, applicants planning a new registration of medicinal products in Ukraine before 1 January 2027 will for now continue to work under the current rules on the requirements for the reference product, while after 01 January 2027 they will be guided by the new requirements.
At the same time, representatives of the Center recommended that companies already planning to update registration materials or enter EU markets should focus on the future legislative requirements and take into account European approaches to the selection of the reference medicinal product.
During the online meeting, participants also had the opportunity to ask questions and receive practical answers from the Center's specialists on the application of the new legislative approaches.
Read more about the meeting in "Shchotyzhnevyk APTEKA" at the link
