of October 27, 2023 No. 1799
About approval of requirements to the medicine registered in the territory of the Russian Federation applied according to indicators (characteristics) of medicine which are not specified in the instruction for its application which inclusion is allowed in standards of medical care to children and clinical recommendations
According to article 37 of the Federal law "About Bases of Protection of Public Health in the Russian Federation" Government of the Russian Federation decides:
1. Approve the enclosed requirements to the medicine registered in the territory of the Russian Federation applied according to indicators (characteristics) of medicine which are not specified in the instruction for its application which inclusion is allowed in standards of medical care to children and clinical recommendations.
2. This resolution becomes effective since September 1, 2024.
Russian Prime Minister
M. Mishustin
Approved by the Order of the Government of the Russian Federation of October 27, 2023 No. 1799
Inclusion of the medicine registered in the territory of the Russian Federation (further - medicine) applied according to indicators (characteristics) of medicine which are not specified in the instruction for its application in standards of medical care to children and clinical recommendations is allowed on condition of compliance to at least than one of the following requirements:
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