ORDER OF THE GOVERNMENT OF THE RUSSIAN FEDERATION

of December 17, 2013 No. 1172

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 enclosed:

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;

changes which are made to the order of the Government of the Russian Federation of October 17, 2011 No. 845 "About Federal Accreditation Service" (The Russian Federation Code, 2011, No. 43, Art. 6079; 2012, No. 27, Art. 3766; 2013, No. 45, Art. 5822).

2. To the Ministry of Economic Development of the Russian Federation in 4-month time to approve procedure for forming and maintaining the register of test laboratories (centers) corresponding to the principles of proper laboratory practice, the corresponding principles of proper laboratory practice of Organization for Economic Cooperation and Development, and the document form, confirming the fact of introduction of data on assignment to test laboratory (center) of the status of compliance to the principles of proper laboratory practice, the corresponding principles of proper laboratory practice of Organization for Economic Cooperation and Development in the specified register.

3. Federal Accreditation Service since July 1, 2015 to provide possibility of provision of the state services, and also interactions with legal entities according to the Rules approved by this resolution, electronically with use of information and telecommunication networks public including to the Internet, and the federal state information system "Single Portal of the State and Municipal Services (Functions)".

Documents (statements) are submitted (go) to Federal Accreditation Service in writing till July 1, 2015 legal entities personally or the registered mail with the assurance of receipt. The Federal Accreditation Service hands documents to legal entities on paper or directs them the registered mail with the assurance of receipt.

4. 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 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.

Approved by the Order of the Government of the Russian Federation of December 17, 2013 No. 1172

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;

"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 and standard rates applied by test laboratory (center) for 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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