RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of July 16, 2012 No. 629

About modification of item 4 of the Regulations on the State register of medicines

The Cabinet of Ministers of Ukraine decides:

Make changes to item 4 of the Regulations on the State register of medicines approved by the resolution of the Cabinet of Ministers of Ukraine of March 31, 2004 No. 411 (The Official Bulletin of Ukraine, 2004, No. 13, Art. 897; 2008, No. 100, Art. 3313; 2010, to No. 57, the Art. 1961), having stated it in such edition:

"4. Such data on medicine are entered in the Register:

name of medicine (trade name, international unlicensed name);

name of the producer, its location and location of its production capacities;

synonyms, chemical name, complete composition of medicine;

pharmacological effect, pharmakoterapevtichesky group of medicine;

indications, contraindications, precautionary measures, interaction with other medicines;

methods of application, dose of active ingredient in each unit and quantity of units in packaging;

side effect, form of release, the storage condition, term of suitability, condition of leave and belonging of medicine to medicines which advertizing is forbidden;

the instruction for medical application of medicine;

pharmacopoeian Article or methods of quality control of medicine.

MZ enters in the Register data on medicine based on the order MZ on its state registration.".

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