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Registration of active pharmaceutical ingredients

The DOCLINX team provides services for including pharmaceutical substances manufactured for sale in the State Register of Medicines (GRLS).

Why is it necessary to include pharmaceutical substances in the GRLS?

Unlike medicinal products, pharmaceutical substances are not subject to registration and do not have a registration certificate. However, according to Federal Law No. 61-FZ "On Circulation of Medicines", information about pharmaceutical substances must be entered into the GRLS. Exceptions are substances produced for clinical trials or export.

How is a pharmaceutical substance included in the GRLS?

There are two ways to include pharmaceutical substances in the GRLS:

During the registration of a medicinal product, if the substance is used only for its production. In this case, the quality examination of the substance is not conducted.
Through a separate state service "Inclusion of a pharmaceutical substance manufactured for sale in the State Register of Medicines". This applies if the substance is produced for independent sale. Information about it is entered into a separate GRLS tab "Pharmaceutical substances", and its quality is examined.

Estimated timeframe for the procedure of including a pharmaceutical substance in the GRLS

From 4 to 7 months.

State fee for including a pharmaceutical substance manufactured for sale in the GRLS

253,000 rubles (item 17, part 1, article 333.32.1 of the Tax Code of theRussian Federation).

Features of including pharmaceutical substances in the GRLS

A foreign manufacturing site must have a GMP certificate from an EAEU member state.
It is not allowed to include the same pharmaceutical substance, manufactured for sale and produced by one manufacturer, in the form of two or more registry entries in the GRLS.

Personalized commercial offer

To receive a personalized commercial offer corresponding to the specifics of your situation, follow the appropriate link and answer a few questions:

Regulatory acts

Federal Law of 12.04.2010 No. 61-FZ "On Circulation of Medicines", Article 34. "Inclusion in the State Register of Medicines and exclusion from the State Register of Medicines of a pharmaceutical substance manufactured for sale"