Russian Ministry amends procedure for licensing the manufacturing of drugs

Print 14 March 2018
GMP News

The Ministry of Industry and Trade of Russia amended its Administrative Rules for licensing the manufacturing of medicinal products.

According to the Ministry, the relevant order was elaborated and approved to improve the quality of provision, period and availability of results of this public service provided by the Ministry, create comfortable conditions for participants in relations arising during the provision of service for licensing the manufacturing of medicinal products for human use, and defining the period and sequence of activities (administrative procedures).

In particular, the Rules were supplemented by clause 16.1, which stipulates that the Ministry of Industry and Trade may not:

  • refuse to provide public service, if the request and documents required for provision of public service were submitted in accordance with the information regarding the period and procedure for provision of public service, as published on the Portal
  • demand that the applicant submits the documents confirming payment of the state duty for provision of public service.

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