Registration of pharmaceutical substances and semi-finished products
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Registration of pharmaceutical substances and semi-finished products

The entry of substances into the state registry or registration of substances is carried out with the aim of import of substances into the territory of the Russian Federation for subsequent use in the manufacture of finished dosage form in the territory of the Russian Federation.

RDG services:

  • Preparation of proposal for registration of the substance (calculation of duration of the procedure, cost)
  • Representation in course of the paperwork (without transfer of rights to possession and the  use of  registration, etc.)
  • Collection and preparation of the registration dossier
  • Submission and support of the registration dossier
  • Testing of analytical methods in the laboratory
  • Organization of logistic services for the import of drugs for the examination
  • Translation of documentation

There is no document confirming the registration of a substance. Data on registered substances and drugs are in the public domain in the register of registered medicines:

Substances are entered into the state register of registered medicinal products without time limits of their location in the registry.

Registration dossier comprises:

  • Administrative documents
  • Description of the substance and intermediates (Drug Master File)
  • Data on the manufacturing process
  • Data on quality control of the substance

Stages of the registration of pharmaceutical substances:

  • Submission of registration dossier to the Ministry of Health
  • Examination of the quality of the substance by FSBI
  • Analysis of examination results by the Ministry of Health
  • Inclusion of the substance in the State Register of Medicinal Products of Ministry of Health

The duration of registration procedures for pharmaceutical substances is 6-7 months.