09/02 16:00 EBA Health Care Committee Registration Subcommittee

On 9 February 2010 the Registration Subcommittee of the EBA Health Care Committee took place in the EBA office in Kyiv. The meeting was visited by the Representatives of the State Pharmacological Centre of Ukraine, First Deputy Director Mrs Baula and Head of the Division on Postregistration Control Mrs Matveyeva.

During the meeting main attention of participants was drawn to the discussion of the issues, raised within the frames of cooperation with the State Pharmacological Centre of Ukraine. Among these, all the presents dwelt on such issues as registration of additional package, requirements to the composition of instructions and other.

Also, the invitees informed the members of the meeting on the cooperation with Derzhlikinspektsiya in pharmacovigilance issues. In view of this, the Draft Order of the Ministry of Health On the Approval of the Procedure of Ban (stoppage) and requisitioning of medical drugs from the circulation on the territory of Ukraine, issued by the Derzhlikinspektsiya was discussed by the presents.

Besides, the update on the status of the Braille font implementation and development of the Draft Law of Ukraine on Medical Drugs (new version) was made.

At the end of the meeting participants dwelt on the situation with the GMP certification process in the State Inspection on Medical Drugs Quality Control. In this regard the Draft CMU Resolution On the Approval of the Procedure of Conduction of Quality Control of Medical Drugs, imported in Ukraine was mentioned and discussed by the Subcommittee members.