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RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of October 23, 2020 No. 88

About approval of Proper practice of storage of medicines

Based on the paragraph of third of article 7 of the Law of the Republic of Belarus of July 20, 2006 "About drug circulation" the Ministry of Health of the Republic of Belarus DECIDES: No. 161-Z

1. Approve Proper practice of storage of medicines it (is applied).

2. Recognize invalid:

the resolution of the Ministry of Health of the Republic of Belarus of January 15, 2007 No. 6 "About approval of Proper practice of wholesale";

the resolution of the Ministry of Health of the Republic of Belarus of November 13, 2008 No. 191 "About entering of amendments and changes into the resolution of the Ministry of Health of the Republic of Belarus of January 15, 2007 No. 6";

Item 2 of the resolution of the Ministry of Health of the Republic of Belarus of March 1, 2010 No. 20 "About approval of the Instruction about procedure and conditions of monitoring procedure of quality of the medicines registered in the Republic of Belarus before receipt in realization, and also the medicines which are in circulation in the territory of the Republic of Belarus, modification and amendments in the resolution of the Ministry of Health of the Republic of Belarus of January 15, 2007 No. 6 and recognition voided resolutions of the Ministry of Health of the Republic of Belarus of June 24, 2002 No. 37 and Item 14 of the resolution of the Ministry of Health of the Republic of Belarus of December 22, 2006 No. 117";

subitem 1.1 of Item 1 of the resolution of the Ministry of Health of the Republic of Belarus of October 25, 2012 No. 163 "About modification and amendments in some resolutions of the Ministry of Health of the Republic of Belarus".

3. This resolution becomes effective since November 20, 2020.

Acting minister

D.L.Pinevich

Approved by the Resolution of the Ministry of Health of the Republic of Belarus of October 23, 2020 No. 88

Proper practice of storage of medicines

Chapter 1. General provisions

1. This Proper practice of storage of medicines (further - Proper practice of storage) establishes rules on stores organization of medicines, medicinal vegetable medicines, pharmaceutical substances, medicinal vegetable raw materials (further if other is not established, - medicines) for the purpose of ensuring their quality and safety and extends on legal entities and the individual entrepreneurs performing pharmaceutical and (or) medical activities, and also other activities according to the legislation providing obtaining, storage, shipment or obtaining and use (application) of medicines.

2. For the purposes of this Proper practice of storage terms and their determinations in the values established by the Law of the Republic of Belarus "About drug circulation" and also the following terms and their determinations are used:

emergency in Holodova of chain - shutdown of electric utility service or other defects in the power supply network, and also defect of work of refrigeration equipment or system operation of the notification;

pharmaceutical warehouse - the complex of specialized rooms and the equipment intended for acceptance, sampling for monitoring procedure of quality, storage, wholesale of medicines and ensuring their safety and quality;

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