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Legislation

Procedures of registration (renewal, introduction of changes), quality control, safety management and turnover of medicinal products are regulated by a great number of various legislative acts. Ukraine has chosen a gradual harmonization of legislation policy with a regulatory system of European Union that leads to the introduction of considerable changes into the legislative acts every several months.

Main legislative acts which we use daily are listed below:

1. The Law of Ukraine “On medicinal products”;

2. The Resolution of the Cabinet of Ministers of Ukraine No. 902 as of 14.09.2005 “On approval of the procedure of state control of the quality of medicinal products imported to Ukraine”;

3. The Resolution of the Cabinet of Ministers of Ukraine No. 376 as of 26.05.2005 “On approval of the procedure of state registration (renewal) of medicinal products and the rates of fee for their state registration (renewal)”;

4. The Order of the Ministry of Health of Ukraine No. 426 as of 26.08.2005 “On approval of the procedure of carrying out of medicinal products materials examination, which are submitted for the state registration (renewal) and also materials examination on introduction of changes into the registration materials during the validity of the registration certificate”;

5. The Order of the Ministry of Health of Ukraine No. 898 as of 27.12.2006 “On approval of the procedure of carrying out of supervision of adverse reactions of medicinal products authorized for medical use”;

6. The Order of the Ministry of Health of Ukraine No. 722 as of 25.08.2010 “On approval of labeling of medicinal products with Braille”;

7. The Order of the Ministry of Healthcare of Ukraine No. 1130 as of 27.12.2012 “On approval of the procedure of confirmation of manufacturing conditions of medicinal products to the requirements of the good manufacturing practice”;

8. The Order of the Ministry of Health of Ukraine No. 1245 as of 17.11.2016 “On approval of the procedure of reviewing of registration materials on medicinal products that are submitted for the state registration (renewal) and materials on the introduction of changes into registration materials during the validity of the registration certificate for medicinal products, which were registered by the competent authorities of the United States of America, Switzerland, Japan, Australia, Canada, medicinal products, which were registered by the competent authority of the European Union according to the centralized procedure”;

9. The Order of the Ministry of Health of Ukraine No. 721 as of 03.11.2015 “On approval of the procedure of carrying out of an examination related to the authenticity of registration materials on the medicinal product, which is being submitted for the state registration for its procurement by a specialized organization”.

 

Please, call +38 (044) 221-71-29, 332-42-94, address by e-mail: info@cratia.ua or come to the meeting at our office to obtain an expert opinion.