Cabinet puts off introduction of GMP certificate for imported medicines until February 15
Ukraine's Cabinet of Ministers has put off the introduction of a requirement to present quality certificates by importers of medicines, taking into account their correspondence to GMP (Good Manufacturing Practice), from January 1 to February 15, 2013.
This is stipulated in government resolution No. 1205 dated December 26, 2012, which was posted on the government's Web site on Saturday.
The document introduces amendments to Clause 2 of Cabinet resolution No. 793 dated August 8, 2012, on state controls on the quality of medicines imported to Ukraine.
As reported, medicine importers were obliged to provide a certificate of quality for medicines, which is in line with GMP requirements, under cabinet resolution No. 793 dated August 8, 2012.
The American Chamber of Commerce in Ukraine, the Association of Pharmaceutical Research and Development (APRaD) and the European Business Association (EBA) earlier asked the cabinet to postpone the taking effect of the resolution from January 1, 2013 to July 1, 2013 and later for May 1, 2013.
The Health Care Ministry's Web site posted a draft Cabinet resolution on amendments to Clause 2 of the No. 793 resolution, which suggested that the introduction of GMP certificates should be rescheduled from January 1 to July 1, 2013.
The head of the State Service for Medicine, Oleksiy Solovyov, recently said that some foreign producers of vitally important medicine which do not have analogues in Ukraine have created one-year or two-year stocks of its pharmaceuticals in Ukraine due to a threat of a halt to their imports from January 1, 2013.
According to Solovyov, 21 items of unique pharmaceuticals currently belong to the at-risk group.