09/09 16:00 EBA Health Care Committee Registration Subcommittee

On 9 September 2008 Health Care Registration Subcommittee met at the EBA Kyiv-based office to continue analysing and discussing the Order of the Ministry of Health No. 391 dated 30 October 2002 On Medical Drug Production Quality Systems Certification Procedure.

The Committee participants drew a conclusion that the relevant working group under the State Service of Medical Drugs and Medical Devices should be established to facilitate introducing amendments to the Order.

During the meeting the Subcommittee members considered inconsistencies in the inspection procedure usually performed at the costs of the recipient party. This practice contradicts the current legislation, which consequently urges officials to make the procedure more transparent.

In order to speed up the process, the State Service of Medical Drugs and Medical Devices should set up a body like a state enterprise (subsidiary legal entity) authorised to run economic activity and conclude agreements.

Also the participants stressed the urgency of concluding the confidential agreement as a separate document or part of the general agreement between a company and the State Service or their authorised body.

Companies expressed their great concerns on this issue. The final amended Order Draft is to be distributed among member companies via e-mail.

was held in Victoriya Hotel. Mr Ihor Sbitnev, the Chairman of the EBA Branch Board, greeted participants and wished them Happy New Year and Merry Christmas. He expressed hope that the next year would bring new opportunities and prospects for business development to the EBA members .