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IT IS REGISTERED

in Ministry of Justice

Russian Federation

On August 31, 2010 No. 18325

ORDER OF THE MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT OF THE RUSSIAN FEDERATION

of August 26, 2010 No. 758n

About approval of the Procedure for suspension of use of medicine for medical application

According to article 65 of the Federal Law of April 12, 2010 N 61-FZ "About drug circulation" (The Russian Federation Code, 2010, N 16, Art. 1815; 4161) I order to N 31, of the Art.:

Approve the Procedure for suspension of use of medicine for medical application according to appendix.

 

Minister T. A. Golikova

Appendix

to the order of the Ministry of Health and Social Development of the Russian Federation of August 26, 2010 No. 758n

Procedure for suspension of use of medicine for medical application

1. This Procedure determines the sequence of procedures and terms of consideration of question of suspension of use of medicine for the medical application which is in circulation in the territory of the Russian Federation (further - medicine).

2. The Ministry of Health and Social Development of the Russian Federation considers question of suspension of use of medicine based on information on the side effects which are not specified in the instruction for use of medicine, serious undesirable reactions, unforeseen undesirable reactions in case of use of medicine on features of its interaction with other medicines which can pose threat of life or to health of patients, and also the data which are not corresponding to the data on medicine containing in the instruction for its application received in type:

analysis results of monitoring of safety of the medicines for medical application provided by Federal Service on Surveillance in Healthcare and Social Development;

addresses about suspension of use of medicine with appendix to it of the documents confirming need of suspension of medicine, provided by developer and (or) producer of medicine addressed to which the registration certificate of medicine for medical application is issued (further - developer and (or) producer of medicine).

3. The responsible Department of the Ministry of Health and Social Development of the Russian Federation performs verification of information obtained according to Item 2 presents of the Procedure within three working days from the date of its obtaining, and makes the decision on issue to federal state budgetary institution on conducting examination of medicines (further - expert organization) tasks for conducting examination of quality of medicine and examination of the attitude of the expected advantage towards possible risk of use of medicine.

4. By results of the carried-out expertizes specified in Item 3 presents of the Procedure, the Ministry of Health and Social Development of the Russian Federation in time, not exceeding five working days from the date of receipt of the conclusions of the commissions of experts of expert organization about establishment that use of medicine poses threat of life or to health of patients, data on medicine do not correspond to the data on medicine containing in the instruction for its application:

makes the decision on suspension of use of medicine for elimination of the reasons posing threat of life or to health of the patient for a period of up to elimination of the reasons posing threat of life or to health of patients or for a period of up to modification of the instruction for use of medicine;

notifies in writing the developer and (or) producer of medicine on the made decision with indication of the reasons and the term of suspension of use of medicine and with application of copies of the conclusions of the commissions of experts of expert organization;

informs Federal Service on Surveillance in Healthcare and Social Development on the made decision with indication of the reasons and the term of suspension of use of medicine.

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