Substance Registration

Entering substances into the state register — or the registration procedure for a pharmaceutical substance — is carried out so that the substance can be imported into the Russian Federation and subsequently used to manufacture a finished dosage form in Russia.

Our services:

• Preparing a substance-registration proposal (estimated duration and cost)
• Representation during documentation preparation (without transfer of ownership or use rights to the registration, etc.)
  • Compiling and preparing the registration dossier
  • Submitting and shepherding the registration dossier
  • Validation of analytical methods in the laboratory
  • Organizing logistics for the import of drugs for expert review
  • Translation of documentation

There is no document confirming substance registration. Data on registered substances and drugs is publicly available in the state register of registered medicines at grls.rosminzdrav.ru.

Substances are entered into the state register of registered drugs with no limitation on the period they remain in the register.

The registration dossier contains:

• Administrative documents
• Description of the substance and intermediates (Drug Master File)
• Manufacturing data
• Substance quality-control data

Registration stages for pharmaceutical substances:

• Submission of the registration dossier to the Ministry of Health
• Quality review of the substance at the Federal State Budgetary Institution
• Analysis of the expert-review results at the Ministry of Health
• Entry of the substance into the State Register of Drugs at the Ministry of Health

The duration of the registration procedure for pharmaceutical substances is 6–7 months.