In this chapter you can find the main legislative acts for registration procedures regulation in Ukraine.
Law of Ukraine
- Law of Ukraine “On medicines” № 124/96ВР of 4.04.96 (available in Ukrainian language - download)
- Law of Ukraine «About narcotic drugs, psychoactive drugs, their analogues and precursors turnover in Ukraine» № 60/95-ВР of 15.02.95 (available in Ukrainian language - download)
Orders of Cabinet of Ministers of Ukraine
- About approval of the Procedure of State control for quality of importing to Ukraine medicinal preparations performing» № 902 of 14.09.2005 (available in Ukrainian language - download)
- Questions regarding State control for quality of medicines performing» of 10.09.08 N 837 (available in Ukrainian language - download)
- Some questions of State governance in quality of medicines control area» of 20.12.08 N 1121 (available on Ukrainian language - download)
- About changes applying to some orders of Cabinet of Ministers of Ukraine» of 20.12.08 N 1122 (available on Ukrainian language - download)
- About realisation of order #28 concerning safety and quality of food of 26.07.06 #1023 (available on Ukrainian language - download)
Orders of MOH of Ukraine
- On Approval of Procedure for Conducting Expert Evaluation of Materials Pertinent to Medicinal Products which are Submitted for State Registration (Re-Registration) and Expert Evaluation of Materials about Introduction of Changes to the Registration Documents during the Validity Period of Registration Certificate» №426 of 25.08.05 (download)
- About Approval of Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials and Model Regulations of the Ethics Committee» №66 of 13.02.06 (download)
- On approval of the Procedure for assigning specialized health care settings where clinical trials of medicinal products may be conducted» №245 of 17.05.07 (download)
- About Approval of Procedure for Surveillance over Adverse Reactions to Medicinal Products Permitted for Medical Use» № 898 of 27.12.06 (download)
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