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.

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, unexpected 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;

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