ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of June 5, 2018 No. 1064

About modification of appendix 3 to the Procedure for conducting examination concerning authenticity of registration materials on medicine which moves on state registration for the purpose of its purchase by the specialized organization

According to article 9 of the Law of Ukraine "About medicines", I ORDER to Item 8 of the Regulations on the Ministry of Health of Ukraine approved by the resolution of the Cabinet of Ministers of Ukraine of March 25, 2015 No. 267,:

1. 721, No. 1453/27898, registered in the Ministry of Justice of Ukraine on November 19, 2015 to state Item 2 of appendix 3 to the Procedure for conducting examination concerning authenticity of registration materials on medicine which moves on state registration for the purpose of its purchase by the specialized organization, to No. approved by the order of the Ministry of Health of Ukraine of November 3, 2015 in the following edition:

"2. The report on medicine assessment - the document which confirms positive assessment of such medicine of its efficiency, safety and quality, constituted by regulatory body of the country where this medicine is registered, or the World Health Organization. The applicant submits the report on medicine assessment on paper.".

2. To management of pharmaceutical activities and quality of pharmaceutical products (Lyaskovsky T. M.) provide in accordance with the established procedure submission of this order on state registration in the Ministry of Justice of Ukraine.

3. To impose control of execution of this order on the deputy minister Ilyk G. G.

4. This order becomes effective from the date of its official publication.

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