About registration

State registration of medicinal products

Any medicinal products are introduced in the civil circulation in the Russian Federation provided that they are registered by the relevant authorized federal agency.

The following is the subject to the state registration:

1) original medicinal products;

2) generic medicinal products;

3) new combinations of the medicinal products registered before;

4) any medicinal products registered before but made in other pharmaceutical form, in new dosage form.

(The Federal Law No. 61-FZ of 12.04.2010 On Circulation of Pharmaceuticals, Article 13)

The Certificate of Pharmaceutical Product and Decision of Entering Pharmaceutical Substance in the State Register of Medical Remedies are the confirmation of medicinal product registration. The data of the registered medicinal product including the data of the substance included as a compound of the medicinal product are represented in the State Register of Medical Remedies.

 

Entering a pharmaceutical substance in the State Register of Medicinal Remedies for Medical Use

The pharmaceutical substances entered in the State Register of Medical Remedies shall be used at manufacturing of any medicinal products.

(The Federal Law No. 61-FZ of 12.04.2010 On Circulation of Pharmaceuticals, Article 45)

§                                 For any pharmaceutical substances included as a compound of a medicinal product – entering in the State Register of Medical Remedies is made within the framework of the state registration of medicinal product.

§                                 For pharmaceutical substances used at the manufacture of medicinal products, entering in the State Register of Medical Remedies is made within the framework of a separate state registration of medicinal product.

(The Federal Law No. 61-FZ of 12.04.2010 On Circulation of Pharmaceuticals, Article 33)

Decision of Entering of Pharmaceutical Substance in the State Register of Medical Remedies is the document proving the entering of a pharmaceutical substance in the State Register of Medical Remedies.