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ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of June 7, 2023 No. 105

About modification of the order of the Minister of Health of the Republic of Kazakhstan of December 20, 2020 No. KR DSM-282/2020 "About approval of rules of evaluating quality of the medicines and medical products registered in the Republic of Kazakhstan"

I ORDER:

1. Bring in the order of the Minister of Health of the Republic of Kazakhstan of December 20, 2020 No. KR DSM-282/2020 "About approval of rules of evaluating quality of the medicines and medical products registered in the Republic of Kazakhstan" (it is registered in the Register of state registration of regulatory legal acts at No. 21836) the following change:

in rules of evaluating quality of the medicines and medical products approved by appendix to the specified order:

2) of Item 12 to state the subitem in the following edition:

"2) for the imported medicines - notarially attested or apostilled according to requirements of the Hague Convention of October 5, 1961 "The list of the states recognizing apostille" (further - the Hague Convention) the copy of the certificate of proper production practice (further - GMP (ДжиЭмПи)), in the PDF format (Pidief), acting at the time of production or the Declaration from the producer with current status of GMP on the website of Management on sanitary inspection behind quality of foodstuff and medicines (USA) (further - FDA (ЭфДиЭй)) without apostille, and the address of the website of the register of the certificates of conformity issued by authorized body to requirements of GMP (in the presence) - with transfer on Kazakh or Russian (in case of submission of the document in foreign language), for the medicines made in the territory of the Republic of Kazakhstan - the document, GMP of the Republic of Kazakhstan confirming compliance of the production site to requirements and the address of the website of the register of the certificates of conformity issued by authorized body to requirements of GMP;".

2. To provide to committee of medical and pharmaceutical control of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan:

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