ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of December 17, 2008 No. 754

About approval of procedures for conducting examination of registration materials on medicines which are made according to the approved copy-books, and developments and approvals of copy-books on traditional medicines

In pursuance of the Law of Ukraine "About medicines" and the paragraph of the eighth Item 3 of the Procedure for state registration (re-registration) of medicines approved by the resolution of the Cabinet of Ministers of Ukraine of May 26, 2005 No. 376, for the purpose of enhancement of the procedure of state registration of medicines which are made according to the approved Ministry of Health (further - MZ) to copy-books, procedures of development and approval of copy-books on traditional medicines I ORDER:

1. Approve the Procedure for conducting examination of registration materials on medicines which are made according to the approved copy-books it (is applied).

2. Approve the Procedure for development and approval of copy-books on traditional medicines it (is applied).

3. To the director of GP "State Pharmacological Center" of the Ministry of Health of Ukraine Chumak V. T. provide:

3.1. The organization of observance of requirements of these Procedures when conducting examination of registration materials on medicines which are made according to the copy-books approved by MZ, and in case of development and approval of copy-books on traditional medicines.

3.2. Submission of this order on state registration in the Ministry of Justice of Ukraine in accordance with the established procedure.

4. To impose control over the implementation of this order on the deputy minister Rybchuk V. O.

Approved by the Order of the Ministry of Health of Ukraine of December 17, 2008, No. 754

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