of November 23, 2011 No. 1413n
"About approval of Methodical recommendations about content and execution of necessary documents of which the registration file on medicine for medical application for the purpose of its state registration is created"
For the purpose of enhancement of procedure for forming of the registration file on medicine for medical application for the purpose of its state registration I order:
Approve Methodical recommendations about content and execution of necessary documents of which the registration file on medicine for medical application for the purpose of its state registration, according to appendix is created.
Minister T. A. Golikova
Appendix
to the order of the Ministry of Health and Social Development of the Russian Federation of November 23, 2011 No. 1413n
1. These methodical recommendations about content and execution of necessary documents of which the registration file on medicine for medical application for the purpose of its state registration is created (further - Methodical recommendations) are developed for the purpose of enhancement of procedure for forming of the registration file on medicine for medical application for the purpose of its state registration.
2. Contents of documents of which the registration file on medicine for medical application for the purpose of its state registration is created are determined according to the order of the Ministry of Health and Social Development of the Russian Federation of August 26, 2010 of N 750 N "About approval of rules of conducting examination of medicines for medical application and form of the conclusion of the commission of experts" (it is registered by the Ministry of Justice of the Russian Federation on August 31, 2010 N 18315).
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