Rada Committee Recommends Adoption of Draft Law on Parallel Import of Medicines

The Committee considered the version of the draft law No. 11173 "On Amendments to Certain Laws of Ukraine (regarding the parallel import of medicines)" prepared for the second reading at its previous meeting on July 3. However, after additional consultations, it became necessary to introduce certain clarifications to its text to improve the procedure for parallel import of medicines and increase their availability to patients.

In particular, it is proposed to:

♦ to postpone the implementation of the provision of the new Law "On Medicinal Products" on granting the Cabinet of Ministers the right to expand the list of countries from which parallel imports may be carried out until Ukraine joins the EU, but not before the full implementation of the medicinal products verification system in Ukraine (i.e., the introduction of 2D coding);

♦ to supplement the final provisions of the draft law with recommendations to the Ministry of Health on the regulation of pharmacovigilance procedures for parallel imported medicinal products;

♦ to eliminate the discretion and allow the State Enterprise Medical Procurement to allow medicinal products unregistered in Ukraine but registered by the competent EU authority under a centralized procedure or by an EU member state or the competent authority of the USA, Switzerland, Japan, Australia, Canada, provided that such medicines are used in these countries or have Ukrainian GMP. At the same time, such medicines will be subject to a simplified registration procedure with its own specifics in addition to the existing ones.

The amendments also provide for the cancellation of state registration under the simplified procedure in case of failure to obtain a Ukrainian GMP certificate and, accordingly, termination of the procurement agreement.

The above clarifications are set out in the relevant amendments of the Committee.

The Committee reconsidered its previous decision on the draft law dated July 3, 2024 (Minutes No. 144) and supported the committee amendments to it.

12 MPs voted in favor: Lada Bulakh, Victoria Vagner, Vasyl Virastiuk, Dmytro Gurin, Oksana Dmytrieva, Artem Dubnov, Valeriy Dubil, Yuriy Zaslavsky, Serhiy Kuzminykh, Maksym Perebyinis, Mykhailo Radutsky, and Olha Stefanyshyna.

As a result, the Committee supported the revised version of the draft law, recommending that the Verkhovna Rada adopt it in the second reading and as a whole as a law.