medicines

draft Resolution of the Cabinet of Ministers of Ukraine "On Amendments to Resolution of the Cabinet of Ministers of Ukraine No. 376 of May 26, 2005"; (12 page(s), in Ukrainian)

The draft Resolution has been developed pursuant to clause 4 of the Section II of the Law of Ukraine No. 4239 of 12 February 2025 "On Amendments to Certain Laws of Ukraine Regarding the Peculiarities of State Registration of Medicines That Can Be Purchased by an Entity Authorized to Carry Out Procurement in the Healthcare Sector and on the Regulation of Certain Issues Related to the Sale of Medicines" and aims to enhance the operational conditions of the national procurement system in the healthcare sector funded by the state budget.

The draft Resolution, in particular, provides for:

- the possibility of a simplified procedure for state registration of a medicine that has been registered by the competent authority of the United Kingdom;

- the possibility of a simplified procedure for state registration of a medicine that is procured by an entity authorized to carry out procurement in the healthcare sector and is either registered by the competent authority of the United Kingdom, or included in the database of medicines eligible for procurement under the United States President's Emergency Plan for AIDS Relief, as published on the official website of the competent U.S. authority, or has received Tentative Approval from the competent authority of the United States, or is included in the list of prequalified medicines or vaccines by the WHO and is manufactured at a production site specified in the list therein as of the date of application submission.

Compared with the previous version of the amendments notified in document G/TBT/N/UKR/337, the updated amendments include, in particular, the following:

the addition of provisions specifying the procedure for submitting an application for state registration of a medicine and the process for consideration of such applications;

the removal of the requirement to submit, together with the application, a certified copy of the patent or license authorizing the manufacture and sale of the registered medicine, as well as a document confirming the validity of the patent in Ukraine, or a letter confirming that the rights of third parties protected by a patent or transferred under a license are not infringed in connection with the registration of the medicine.