Medicines

Draft Order of the Ministry of Health of Ukraine "On Approval of Amendments to the Procedure for Confirmation of Compliance of Manufacturing Conditions of Medicines with the Requirements of Good Manufacturing Practice"; (5 page(s), in Ukrainian), (4 page(s), in English)

The draft Order of the Ministry of Health of Ukraine "On Approval of Amendments to the Procedure for Confirmation of Compliance of Manufacturing Conditions of Medicines with the Requirements of Good Manufacturing Practice" has been developed pursuant to Article 9-1 "Peculiarities of state registration of medicines that may be procured by a person authorised to conduct procurement in the healthcare sector" of the Law of Ukraine "On Medicines", as well as to confirm compliance of manufacturing conditions with the requirements of good manufacturing practice for those medicines procured by a person authorized to conduct procurement in the healthcare sector. The draft Order provides for the regulation of the procedure for confirming the compliance of the manufacturing conditions of medicines registered by the competent authority of the United States of America, the Swiss Confederation, Japan, Australia, Canada, a Member State of European Union, or registered by the competent authority of European Union under a centralised procedure. This is intended for the purposes of procurement conducted by a person authorised to carry out procurement in the healthcare sector, in accordance with the requirements of Good Manufacturing Practice (GMP) issued by the competent authority of the USA, Switzerland, Japan, Australia, Canada, and EU Member State, based on the results of an inspection for compliance with GMP requirements.