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

of April 14, 2011 No. 321n

About the registration certificate of medicine for medical application

I order:

1. Make changes to the form of the registration certificate of medicine for medical application approved by the order of the Ministry of Health and Social Development of the Russian Federation of August 26, 2010 of N 745 N (it is registered by the Ministry of Justice of the Russian Federation on August 31, 2010 registration N 18297), having added with the note of the following content:

"Note: the registration certificate of medicine for medical application can have the appendices which are its integral part (about what the corresponding entry in the state register of medicines for medical application is made) and the containing changed data on the name and the address of the legal entity addressed to whom the registration certificate, and about medicine for medical application is issued.".

2. Determine that in case of change of the data containing in the registration certificate of medicine (names and addresses of the legal entity addressed to whom 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 the order of the Ministry of Health and Social Development of the Russian Federation of August 26, 2010 of N 745 N *

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