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Ministry of Justice of Ukraine

December 10, 2021

No. 1601/37223

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of November 3, 2021 No. 2414

About modification of the Procedure for carrying out industry certification of laboratories of quality control and safety of medicines

According to the paragraph to the thirteenth part one of article 15 of the Law of Ukraine "About medicines", Concepts of the Nation-wide program of adaptation of the legislation of Ukraine to the European Union law approved by the Law of Ukraine of November 21, 2002 to No. 228-IV, 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 (in edition of the resolution of the Cabinet of Ministers of Ukraine of January 24, 2020 to No. 90), for the purpose of further enhancement of standardization and quality control of medicines I ORDER:

1. Make change to Item 6 of appendix 3 to the Procedure for carrying out industry certification of laboratories of quality control and safety of medicines approved by the order of the Ministry of Health of Ukraine of January 14, 2004 No. 10, registered in the Ministry of Justice of Ukraine on January 30, 2004 for No. 130/8729, having stated it in the following edition:

"6. The list of methods of measurements (testing) which the laboratory (according to the State pharmacopeia of Ukraine and/or the European pharmacopeia can carry out, and in the absence of requirements in these pharmacopeias - other leading pharmacopeias (The British pharmacopeia, pharmacopeia of the USA, pharmacopeia and regulatory legal acts establishing requirements to medicine).".

2. To management of provision of medicines (Zadvornykh I. S.) provide submission of this order in the procedure established by the legislation on state registration in the Ministry of Justice of Ukraine.

3. To impose control of execution of this order on the First Deputy Minister of Health of Ukraine Komaridu A. A.

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