On August 11, 2011 the Ministry of Justice of Ukraine has registered the Order of the Ministry of Health “On Approval Procedure of Unregistered Medicals, Standard Samples and Reagents Import into the Territory of Ukraine” No. 237 as of April 26, 2011. The Order is set to come into effect on 26 August 2011.
Prior to that, on January 24, 2011 the Ministry of Health of Ukraine made public the Draft Order introducing the amendments to the procedure of unregistered drugs import into Ukraine. Later on EBA HCC Clinical Trials Subcommittee elaborated the set of proposals to the legislation and called on Ministry of Health of Ukraine and Mr. Andriy Klyuyev, the First vice Prime Minister of Ukraine, Minister of Economic Development and Trade to further review and negotiate the provisions of the Draft Order before it goes to the parliamentary hearings.
Thus, in April 2011 EBA HCC Clinical Trials Subcommittee in conjunction with the Ministry of Health of Ukraine and the State Expert Centre initiated the Draft Order reconsideration and finalising.
All standpoints and novelties advocated by the EBA have been successfully embroidered into the revised wording of the Draft Order, namely:
- The timeline for approval has been shortened from 30 working days to 10 respectively;
- Point 4.3. of the Draft Order has been amended.
- The list of documents to be submitted to the Ministry of Health of Ukraine for clinical trials and state registration of unregistered medicals imported into the customs territory of Ukraine:
– Applicant’s letter of appeal specifying the reason of importing (in free format);
– Letter of approval issued by the State Expert Centre;
– Quality certificate (copy);
– Invoice or pro-forma of the invoice (copy).
We are happy to share this success important for the Clinical Trials Subcommitte members who have been waiting for the simplified procedure of unregistered medicals import into the territory of Ukraine.
At the same time, the EBA Health Care Committee keeps lobbying the issue with respect to the procedure of importing standard samples of registered medical drugs which is still unsolved.