ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of December 6, 2001 No. 486

About approval of regulatory legal acts concerning control of quality of medical immunobiological supplies

According to Regulations on control of compliance of immunobiological medicines which are applied in medical practice, to the requirements of the state and international standards approved by the resolution of the Cabinet of Ministers of Ukraine of 15.01.96 of N73 (with the changes made by the resolution of the Cabinet of Ministers of Ukraine of 21.06.2001 of N 678, Regulations on State department on control of quality, safety and the production of medicines and products of medical appointment approved by the resolution of the Cabinet of Ministers of Ukraine of 05.06.2000 of N 917, taking into account regulations which are applied in the international practice, directives of the European Economic Commonwealth 65/65 EEC, 75/318 EEC and being guided "By the guidelines for national authorities concerning quality assurance of biological medicines" "Regulation and licensing of biological medicines in the countries with for the first time the organized regulating authorities" (series of technical reports of VOOZ, N 822, 1994 and N 858, 1998),

I ORDER:

1. Approve:

1.1. The procedure for carrying out state registration (re-registration) for medical immunobiological supplies in Ukraine (is applied).

1.2. The procedure of control of quality of medical immunobiological supplies which are used, made or offered in medical practice in Ukraine (is applied) to application.

1.3. Ceased to be valid

1.4. Ceased to be valid

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