ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of May 17, 2001 No. 185

About approval of criteria of determination of categories of leave of medicines

According to article 12 of the Law of Ukraine "About medicines", the Presidential decree of Ukraine of 11.06.98 No. 615 "About approval of strategy of integration of Ukraine to the European Union" and in pursuance of the order MZ of Ukraine of 19.09.2000 No. 220 "About approval of procedure for conducting examination of materials on medicines which go for state registration (re-registration), and also examinations of materials about modification of registration documents during action of the registration certificate"

I ORDER:

1. Approve criteria of determination of categories of leave of medicines (are applied).

1. To provide to the director of the MZ State pharmacological center of Ukraine O. V. Stefanov provision of this order on state registration in the Ministry of Justice of Ukraine and the publication in mass media.

2. Perform measures concerning introduction of requirements of this order in case of registration (re-registration) of medicines, since 01.01.2002.

3. To impose control of execution of this order on the deputy minister Korotko O. Sh.

Approved by the Order of the Ministry of Health of Ukraine of May 17, 2001 No. 185

Criteria of determination of categories of leave of medicines

1. General provisions

Criteria of determination of categories of leave of medicines are developed according to Art. 12 of the Law of Ukraine "About medicines", Rules of management of medicines in the European Union, in particular the directive 92/26/EEC "About determination of categories of medicines for the person" of 31.03.92 (Brussels).

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