Medicines

Draft Order of the Ministry of Health of Ukraine "On Approval of the Procedure for Imposing a Prohibition (Temporary Prohibition) and Withdrawal of Medicines from Circulation on the Territory of Ukraine"; (24 page(s), in Ukrainian)

The draft Order has been developed pursuant to Article 109(6) of the Law of Ukraine No. 2469-IX of 28 July 2022 "On Medicines" and aims to improve the procedure for imposing a prohibition (temporary prohibition) on the circulation of medicines, withdrawing medicines from circulation by the state control authority and recalling medicines from circulation by the marketing authorisation holder. It also provides for a mechanism for restoring the circulation of medicines and for preventing the circulation of substandard, unregistered (except as provided for by Law of Ukraine No. 2469-IX) and counterfeit medicines.

The Procedure approved by the draft Order sets out the process for adopting decisions to impose a prohibition (temporary prohibition) on the circulation in Ukraine of batches of medicines that do not comply with the requirements established by legislation and regulatory documents, as well as medicines imported into or exported from Ukraine in violation of the applicable legal requirements. It also establishes the procedure for the withdrawal of such medicines from circulation. In addition, the draft Order repeals Order of the Ministry of Health of Ukraine No. 809 of 22 November 2011 "On Approval of the Procedure for Establishment Prohibition (Temporary Prohibition) and Restoring the Circulation of Medicinal Products in Ukraine" (notified in document G/TBT/N/UKR/70).