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ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of September 20, 2019 No. 1227

About recognition and about assessment of conformity of test laboratories (centers) to the principles of proper laboratory practice, the corresponding principles of proper laboratory practice of Organization for Economic Cooperation and Development

According to Item 12 of article 46 of the Federal law "About Technical Regulation" Government of the Russian Federation decides:

1. Approve the enclosed Rules of recognition and assessment of conformity of test laboratories (centers) to the principles of proper laboratory practice, the corresponding principles of proper laboratory practice of Organization for Economic Cooperation and Development.

2. Determine that the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation, the Ministry of Agriculture of the Russian Federation, Federal Service for the Oversight of Consumer Protection and Welfare, Federal Service for Veterinary and Phytosanitary Surveillance, the Federal Service on supervision in health sector, Federal Medical Biological Agency and Federal Agency for Technical Regulation and Metrology provide according to this resolution participation of workers of federal executive bodies and federal state institutions subordinated to them or the federal unitary enterprises in procedures of recognition and assessment of conformity of test laboratories (centers) to the principles of proper laboratory practice, the corresponding principles of proper laboratory practice of Organization for Economic Cooperation and Development.

3. Recognize invalid:

Item of 3 changes which are made to acts of the Government of the Russian Federation, approved by the order of the Government of the Russian Federation of December 15, 2016 No. 1363 "About introduction of amendments to some acts of the Government of the Russian Federation" (The Russian Federation Code, 2016, No. 52, the Art. 7632).

Russian Prime Minister

D. Medvedev

Approved by the Order of the Government of the Russian Federation of September 20, 2019 No. 1227

Rules of recognition and assessment of conformity of test laboratories (centers) to the principles of proper laboratory practice, corresponding principles of proper laboratory practice of Organization for Economic Cooperation and Development

I. General provisions

1. These rules establish procedure for recognition and assessment of conformity of test laboratories (centers) to the principles of proper laboratory practice, the corresponding principles of proper laboratory practice of Organization for Economic Cooperation and Development (further - the principles of proper laboratory practice).

Recognition and assessment of conformity of test laboratories (centers) to the principles of proper laboratory practice are performed based on check of observance of requirements of the documents by test laboratories (centers) in the field of standardization included in the list of documents in the field of standardization which observance of requirements by test laboratories (centers) when carrying out laboratory researches provides compliance of the specified test laboratories (centers) to the principles of proper laboratory practice, to the corresponding principles of proper laboratory practice of Organization for Economic Cooperation and Development, No. 2067-r approved by the order of the Government of the Russian Federation of November 8, 2013.

2. The concepts used in these rules mean the following:

"audit of not clinical (preclinical) laboratory clinical trial" - the comparison of primary data and records on not clinical (preclinical) laboratory clinical trial with the data and records containing in interim and final reports performed within inspection;

"applicant" - the legal entity applying for receipt (confirmation) of the status of compliance by test laboratory (center) to the principles of proper laboratory practice;

"considerable discrepancies" - discrepancies of test laboratory (center) to the principles of proper laboratory practice which can affect integrity and quality of the obtained data of not clinical (preclinical) laboratory clinical trial;

"the inspector of body of monitoring" - the employee of body of monitoring or federal state institution subordinated to it who is the head of inspection team;

"inspection" - conducting verification of the procedures applied by test laboratory (center) to determination of degree of its compliance to the principles of proper laboratory practice;

"test laboratory (center)" - division of the legal entity, in the place (places) of stay of which not clinical (preclinical) laboratory clinical trials are conducted, there are rooms and the equipment necessary for their accomplishment, and also group of specialists and the head of researches;

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