Cabinet improves medicine registration rules
In Ukraine, the Cabinet of Ministers on March 27 amended resolution No. 374 dated May 26, 2005, on the approval of the rules of the public registration of medicines.
According to the document posted on the government’s website, the government improved the rules of the public registration or re-registration of medicines, in particular, the rules of providing access to the results of their clinical trials and obliged the Health Ministry to publish all the results of the nonclinical and clinical trials for medicines.
In addition, the government extended the registration certificates of medicines to be procured by international organizations using national budget funds and canceled the mandatory provision of a GMP document for re-registration.
These changes will ensure free access to information on the medicine and eliminate the risks associated with disruptions in medical supplies due to the delay of the public registration caused by the updating of the GMP certificates.