The Cabinet of Ministers of Ukraine adopted the Regulation "On changes to the state registration (re-registration) of medicinal products", dated March 18, 2015 № 125, developed by the Ministry of Healthcare of Ukraine (hereinafter - the Regulation). This Resolution established important changes to the Regulation of the Cabinet of Ministers of Ukraine, dated 26.08.2005. № 376. In particular, regulations have been complied with recent amendments to the Law of Ukraine "On medicinal products".
Thus, the Regulation provides abolition of repeated re-registration of all medicinal products, excepted cases when marketing authorization was terminated by the Ministry.
This legal norm was introduced for carrying out the provisions of the Law: "After the expiration of the period of permitted use of the medical products in Ukraine, its further use is possible after re-registration. After the re-registration the using term of medicinal product in Ukraine is not limited."
In addition, the Regulation simplified procedure of registration of original medicinal products registered by the European Medicines Agency.
Thus, the state registration of such medicinal products will be carried out without examination by SES on of the application, registration documents, including the report of the evaluation of the registration dossier of mentioned Agency, and report of SES on compliance of application sheet and quality control methods for medicinal products with registration materials.
It should be noted that the legislation does not set such norm, so, establishment of simplified procedure for original products was made at the level of government decision.
The new Order simplifies state registration of medicinal products exclusively for the treatment of tuberculosis, HIV / AIDS, viral hepatitis, cancer and rare (orphan) diseases, registered by the competent authorities of the United States, Switzerland, Japan, Australia, Canada and the European Union as medicinal products.
Thus, the following documents should be attached to the application for registration of medicinal products:
1) Duly certified copy of the document issued by the State Administration of Ukraine on Medicinal Products confirming compliance of production conditions with current requirement of GMP in Ukraine, or written obligation of producer to produce relevant medicinal product for supplying into Ukraine on the same production facilities used in medicinal products production for use in the United States, Switzerland, Japan, Australia, Canada and members-states of the European Union;
2) materials concerning the quality control of the medicinal product;
3) samples of drug packaging labelled in accordance with requirements in Ukraine;
4) application sheet for the medicinal product, described in accordance with requirements in Ukraine;
5) document confirming payment of the registration fee.
In addition, the term of taking decision on registration or rejection on registration by the Ministry of Healthcare of Ukraine was shorten: from 30 days to 7 days.
Also, it should be noted that the Regulation provides an opportunity for applicant to register the active pharmaceutical ingredient in the composition of the finished medicinal product.
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