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2020

14/08 16:00 EBA Health Care Committee Registration Subcommittee

On 14 August 2008 Health Care Registration Subcommittee met at the EBA Kyiv-based office to analyse and discuss the Order of the Ministry of Health No. 391 dated 30 October 2002 On Medical Drug Production Quality Systems Certification Procedure.
The Committee participants agreed to focus their exclusive attention on this urgent issue. During the first part of the meeting the Subcommittee members discussed amendments to the Order outlined by State Service of Medical Drugs and Medical Devices. Previously some member-companies also forwarded their comments and changes to the Order.
Conformity Assessment Procedure is closely connected with implementation of the Resolution of the Cabinet of Ministers No 902. Some provisions do not correspond to the WTO requirements and should be amended.
Another agenda issue centred on the previous agreement with the State Pharmacological Center to hold the Seminar on the Pharmacovigilance. Companies expressed their great concern in this respect. Topic ideas are to be distributed among member-companies via e-mail.


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