Ukraine. Requirement on the GMP confirmation came into force on 15 February 2013

On 3 January 2013 Resolution of the Cabinet of Ministers of Ukraine (“CMU”) №1205 “On Amending Clause 2 of the Resolution of the Cabinet of Ministers of Ukraine №793 of 8 August 2012” came into force. According to the Resolution, new requirements for submitting conclusions on local confirmation with GMP compliance, as well as certificates of analysis while performing quality control of imported medicinal products, will come into force in 15 February 2013.

We would like to remind our readers that CMU’s Order № 793 dated 8 August 2012 “On the adoption of the procedure of the state control over the quality of medicines imported to Ukraine” provides for the additional requirements to the list of the documents which are to be submitted for the receipt of confirmation of the quality of the imported goods. In particular, the copy of the document issued by the State Service Ukraine on Medicines confirming the compliance of conditions of medicines production to those established in Ukraine should be submitted.

The failure to submit such document makes it impossible to sell medicine in the territory of Ukraine.

Source: KPMG Ukraine