The inclusion of pharmaceutical substances in the SRMP is carried out in order to be able to be imported into the territory of the Russian Federation for subsequent use in the manufacture of finished dosage forms in the territory of the Russian Federation.
For the inclusion of a pharmaceutical substance produced for sale in the state register of drug products, an examination of its quality is carried out.
But Federal Law No. 61-FZ does not contain provisions for a separate procedure of state registration of pharmaceutical substances with the issuance of appropriate registration certificates.
Entry of pharmaceutical substances into SRMP
Our company offers a range of services for the organization of work on the inclusion of pharmaceutical substances produced for sale in the state register of drug products in accordance with the special procedure defined in Art. 34 of Federal Law No. 61-FZ.
In addition, we provide services for amending the documents on the pharmaceutical substance produced for sale and included in the state register of drug products in accordance with existing legislation.
We will be happy to advise you, relying on reputable professional experience and ongoing monitoring of legal requirements.
All information on the registered pharmaceutical substances are publicly available in the state register of medicinal products (SRMP) grls.rosminzdrav.ru