Cooperation between the State Expert Center of Ministry of Health of Ukraine (SEC and MOH) and the Association’s Health Care Committee (Association’s Committee) proceeds with positive results. Now we witness one more step towards the harmonization of the Ukrainian legislation in the area of medical drugs’ registration with the EU standards.
We are pleased to inform that according to the SEC letter received by the Association, the Draft MOH Order, which amends the format and the description of the registration certificate for medical drugs (MOH Order No.358 dated 29 July 2003) is developed. According to the anticipated amendments there is no further need to indicate information on the frequency of PSURs’ submission (safety report updates) in the registration certificates for medical drugs. This step is in line with the EU practices where the above-mentioned information is not included into the registration certificates for medical drugs. Moreover, nowadays the information on the periodic safety reports’ submission is indicated in a different manner in a number of registration certificates giving rise to unnecessary work complications.
For now, based on SEC’s information, the relevant MOH Order is already at the Ministry of Justice of Ukraine waiting for its state registration.
Association’s Committee is thankful to SEC for facilitation of the issue’s resolution and is looking forward to see the relevant essence of the MOH Order and its soonest publication. Simultaneously, we pay attention to the necessity to ensure timely exchange of effective registration certificates with the newly-formatted ones.