Medicinal products

Draft Order of the Ministry of Health of Ukraine "On Approval of Amendments to the Procedure for Confirmation of Compliance of Medicinal Products Manufacturing Conditions with the Requirements of Good Manufacturing Practice"; (3 page(s), in Ukrainian)

The draft Order provides for the approval of amendments to the Procedure for Confirmation of Compliance of Medicinal Products Manufacturing Conditions with the Requirements of Good Manufacturing Practice, approved by the Order of the Ministry of Health of Ukraine No. 1130 of 27 December 2012.

The amendments to the Procedure will provide legislative regulation of the mechanism for extending the validity of the GMP Conclusion, as well as the possibility of extending the validity of the GMP certificate until the end of 2024 issued by the authorized body of an EU member state, the United Kingdom or a state that has a mutual recognition agreement with the EU or Ukraine.

Approval of the amendments to the Procedure will align it with EU requirements.