Registration of pharmaceutical substances

inclusion of pharmaceutical substances in the National Register of Medicinal Products

In accordance with Part 4 of Article 45 of the Federal Law of the Russian Federation of April 12, 2010 № 61-FZ “On circulation of medicinal products”, “in production of medicines the pharmaceutical substances are used which are included in the National Register of medicines”. On the basis of Article 33 of the Federal Law of April 12, 2010 № 61-FZ “On circulation of medicinal products” there are two ways provided to include pharmaceutical substances in the National Register of medicines:

1) For pharmaceutical substances that are components of the medicinal product - as part of the state registration of the medicinal product.

In this case, a pharmaceutical substance will only be used for the production of the specified medicinal product. Expertise of the quality of the pharmaceutical substance is carried out as a part of the registration of finished dosage form.

2) For the pharmaceutical substances which are not used in the production of medicinal products – as part of a separate registration process.

In this case, a pharmaceutical substance can be used as part of any medicinal products at any pharmaceutical industries. Expertise of the quality of pharmaceutical substance is carried out in accordance with Article 34 of the Federal Law of April 12, 2010 № 61-FZ “On circulation of medicinal products”

The document confirming the inclusion of the pharmaceutical substance in the National Register of medicines is a decision on the inclusion of the pharmaceutical substance in the National Register of medicines.

Stages of the registration of the pharmaceutical substance which is not used in the production of finished dosage form

Stage I - expertise of the quality of pharmaceutical substance (quality control of the pharmaceutical substance in an authorized laboratory center and approval of regulatory documents);

Phase II - Acceptance of Health Ministry of Russia of the decision on the inclusion of the pharmaceutical substance in the National Register of medicines.

RusRusClinic CRO provides the following services to include the pharmaceutical substance in the National Register of medicines.

  • Customer consultation on inclusion of the pharmaceutical substance in the National Register of medicines;
  • Preparation of a plan on inclusion the pharmaceutical substance in the State Register of medicines and a list the necessary documents;
  • Adaptation of the documentation provided by foreign partners, to the requirements of the Russian Federation;
  • Development of regulatory documents for the pharmaceutical substance;
  • Formation of a registration dossier;
  • Submission of the registration dossier to the authorized federal executive body carrying out state registration of medicines (Ministry of Health and Social Development of the Russian Federation);
  • Maintenance of the process of inclusion of the pharmaceutical substance in the National Register of medicines;
  • Obtaining permits, decisions and official requests of the authorized federal executive body carrying out state registration of medicines;
  • Preparation of additional materials as requested by the authorized federal executive body carrying out state registration of medicines;
  • Receiving the decision on inclusion of the pharmaceutical substance and approved documentation (normative documents, packaging layouts) of the pharmaceutical substance.