ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

of August 13, 2012 No. 82n

About approval of form of the registration certificate of medicine for medical application

According to article 27 of the Federal Law of April 12, 2010 N 61-FZ "About drug circulation" (The Russian Federation Code, 2010, N 16, the Art. 1815, N 31, the Art. 4161, N 42, the Art. 5293, N 49, Art. 6409; 2011, N 50, Art. 7351; 2012, N 26, 3446) I order to the Art.:

1. Approve form of the registration certificate of medicine for medical application according to appendix.

2. Determine that:

the registration certificate of medicine for medical application is drawn up on the form which is the protected printed material with degree of protection of level "B";

in case of change of the data containing in the registration certificate of medicine for medical application the changed registration certificate of medicine for medical application with the same number and registration date, with indication of date of renewal of the registration certificate of medicine for medical application is drawn up;

in case of change of the data containing in the registration certificate of medicine (the name and the address of the legal entity addressed to which the registration certificate is issued; trade name of medicine; international non-proprietary name or chemical name of medicine; the list of the substances which are part of medicine, or quantity of each of them; dosage form; dosages; primary package of medicine, quantity of doses in packaging, completeness of packaging; details of the regulating documentation), issued till September 1, 2010, such registration certificate is subject to replacement, without change of its number, on the registration certificate of medicine for medical application in the form approved by this order;

the registration certificates of medicine for medical application issued before entry into force of this Order are acting according to the terms specified in them.

3. Declare invalid:

the order of the Ministry of Health and Social Development of the Russian Federation of April 14, 2011 N 321 N "About the registration certificate of medicine for medical application" (it is registered by the Ministry of Justice of the Russian Federation on May 18, 2011 N 20784).

Appendix

to the order of the Ministry of Health of the Russian Federation of August 13, 2012 No. 82n

The registration certificate of medicine for medical application

See Appendix (4Kb In original language)

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