Main principles of the state registration innovational and generic medical products in Ukraine
Abstract
The lead analysis of a law-legal field of Ukraine regulating procedure of the state registration of medical products, has shown, that main principles of carrying out of such procedure - are as much as possible approached to norms of the legislation of the countries of EU. The basic law-legal acts of Ukraine determining the order of carrying out of procedure of the state registration of medical products are submitted. Main principles of formation of materials of the registration file and approaches to their registration are determined. Presence of automatic dependence on a choice the applicant such as the application for the state registration of medical products and is marked by «depth» of the submitted data.
References
Law of Ukraine "On Medicinal Products" // Bulletin of the Verkhovna Rada of Ukraine.— 1996. —№ 22. - Art. 86.
Resolution of the Cabinet of Ministers of Ukraine of 26.05.2005 № 376 "On approval of the Procedure for state registration (re-registration) of drugs and the amount of the fee for their state registration (re-registration)" // http: // zakon 1.rada.gov.ua /.
Resolution of the Cabinet of Ministers of Ukraine of 26.05.2005 № 1277 "On Amendments to the Resolution of the Cabinet of Ministers of Ukraine of 26.05.2005 № 376" // Official Gazette of Ukraine. - 2007. - № 83. - S. 31—32.
Order of the Ministry of Health of Ukraine dated 26.08.2005 № 426 "On approval of examination of registration materials for medicinal products submitted for state registration (re-registration), as well as examination of materials on changes to registration materials during the registration certificate" // http: //zakonl.rada.gov.ua/,
Order of the Ministry of Health of Ukraine dated 17.04.2007 № 190 "On approval of the Procedure for conducting additional tests of medicinal products during the examination of registration materials" // http: // zakonl.rada.gov.ua/.
Order of the Ministry of Health of Ukraine dated 11.09.2007 № 536 "On amendments to the order of the Ministry of Health of Ukraine dated 26.08.2005 № 426" //http://zakonl.rada.gov.ua/cgi-bin/laws/.
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