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Ministry of Justice

Russian Federation

On October 9, 2015 No. 39263

THE ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION AND THE FEDERAL SERVICE OF THE RUSSIAN FEDERATION ON SUPERVISION TO HEALTH SECTOR

of August 7, 2015 No. 5539

About approval of procedure of selective control of quality of medicines for medical application

According to part 7 of article 9 of the Federal Law of April 12, 2010 No. 61-FZ "About drug circulation" (The Russian Federation Code, 2010, No. 16, Art. 1815; No. 31, Art. 4161; No. 42, Art. 5293; No. 49, Art. 6409; 2011, No. 50, Art. 7351; 2012, No. 26, Art. 3446; No. 53, Art. 7587; 2013, No. 27, Art. 3477; No. 48, Art. 6165; 2014, No. 11, Art. 1098; 43, of the Art. 5797, No. 52, of the Art. 7540) I order to No.:

1. Approve the enclosed Procedure of selective control of quality of medicines for medical application (further - the Procedure).

2. Determine that Procedure provisions regarding obligatory provision of the data specified in Procedure Item 8 become effective after three months from the date of publication of this Order.

3. I reserve control of execution of this Order.

Head

M. A. Murashko

Approved by the Order of the Federal Service of the Russian Federation on supervision in health sector of August 7, 2015, No. 5539

Procedure of selective control of quality of medicines for medical application

1. This Procedure establishes requirements to implementation of selective control of quality of medicines for medical application (further - the Procedure).

2. Subject of selective control of quality of medicines is confirmation of conformity of medicines for medical application and pharmaceutical substances of national and foreign production (further - medicines) to requirements of pharmakopeyny Article or in case of its lack of the regulating documentation (further - the regulating documentation).

3. Selective control of quality of medicines is exercised by the Federal Service on supervision in health sector (further - Roszdravnadzor) and its territorial authorities (further - territorial authorities of Roszdravnadzor).

4. Officials, representatives to exercise selective control of quality of medicines, are:

1) head (deputy managers) of Roszdravnadzor, heads (deputy managers) of territorial authorities of Roszdravnadzor;

2) heads of structural divisions of Roszdravnadzor, and its territorial authorities, their deputies whose official regulations provide powers on implementation of selective control of quality of medicines;

3) other government civil servants of Roszdravnadzor and its territorial authorities which official regulations provide powers on implementation of selective control of quality of medicines.

5. Selective control of quality of medicines includes <1>:

--------------------------------

<1> Article 9 of the Federal Law of April 12, 2010 No. 61-FZ "About drug circulation" (The Russian Federation Code, 2010, No. 16, Art. 1815; No. 42, Art. 5293; No. 49, Art. 6409; 2011, No. 50, Art. 7351; 2012, No. 26, Art. 3446; 2013, No. 27, Art. 3477; No. 48, Art. 6165; 2014, No. 43, Art. 5797; No. 52, Art. 7540, 2015, No. 29 (part I), Art. 4367).

1) processing of the data without fail provided by subjects of drug circulation on series, batches of the medicines arriving in civil circulation in the Russian Federation;

2) sampling of medicines at subjects of drug circulation for the purpose of carrying out conformity testings to requirements of the regulating documentation;

3) acceptance by results of the carried-out testing of the decision on further civil circulation of the corresponding medicine;

4) acceptance by the authorized federal executive body of the decision on the transfer of medicine to poseriyny selective control of quality of medicines in case of repeated detection of discrepancy of quality of medicine to the established requirements and (if necessary) about check of the subject of drug circulation.

6. For the purpose of implementation of selective control of quality of medicines by Roszdravnadzor (territorial authorities of Roszdravnadzor) necessary testing will be organized.

7. For the purpose of carrying out testing of medicines for compliance to requirements of the regulating documentation within selective control of quality of medicines Roszdravnadzor (territorial authorities of Roszdravnadzor) attracts Federal state budgetary institution "Information and Methodical Center for Examination, Accounting and Analysis of the Address of Means of Medical Application" of Roszdravnadzor (further - the expert organization).

8. Roszdravnadzor carries out collection and processing of images about series, batches of the medicines arriving in civil circulation in the Russian Federation, without fail provided by the organizations performing production of medicines in the Russian Federation and import of medicines to the Russian Federation:

8.1. about series of the medicines made in the territory of the Russian Federation:

1) trade name of medicine;

2) international non-proprietary name of medicine (grouping or chemical name);

3) release form (with indication of dosage form, dosage, medicine packing) and quantities in packaging;

4) name of the producer of medicine;

5) amount of the series put into civil circulation (for medicines - quantity of units of packagings, for pharmaceutical substances - with indication of units of measurements);

6) the name of the organization which put medicines into civil circulation;

7) the address of warehouse on which storage of series of medicine after confirmation by the authorized person of domestic manufacturer of medicines of compliance of medicine to the requirements established in case of state registration (permission to release) is performed;

8) number and acceptance date of the declaration of conformity, the name of certification body, the name of the organization which adopts the declaration of conformity (for medicines, subject to confirmation compliance in the declaration form <1>);

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<1> The single list of products which confirmation of conformity is performed in the form of adoption of the declaration of conformity, No. 982 approved by the order of the Government of the Russian Federation of December 1, 2009 "About approval of the single list of products, the subject obligatory certification, and the single list of products which confirmation of conformity is performed in the form of adoption of the declaration of conformity" (The Russian Federation Code 2009, No. 50, Art. 6096; 2010, No. 12 Art. 1344, 1345; No. 31, Art. 4246; No. 43, Art. 5517; No. 47, Art. 6129; 2012, No. 13, Art. 1525; No. 20, Art. 2537; No. 26, Art. 3517; 2013, No. 10, Art. 1032; No. 41, Art. 5187; No. 46, Art. 5951; 2014, No. 30, Art. 4315; No. 32, Art. 4510; No. 41, Art. 5539; No. 43, Art. 5914; 2015, No. 15, Art. 2270).

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