Article 34. Expert evaluation of the quality of drug substance not used in the manufacture of drug products

Steps and term of the inclusion of a drug substance in the State register of drugs are described in this article. Only substances included in the State register (authorized) can be used in the manufacture of drug products.

As a drug substance is not a drug product, the expert evaluation of efficacy and safety and approval of the prescribing information are not necessary to register it. Consequently, the term for inclusion of a drug sunstance in the State register is significantly less than that of a drug product.

1. Application for the inclusion of a drug substance in the State register of drugs

Application for the inclusion of a drug substance in the State register of drugs must be submitted to the competent federal executive authority.

Within 5 workdays (article 34, paragraph 4) after receipt of the application, the competent federal executive authority (MoH) shall

- verify completeness of the submitted data,- decide upon a task to the expert institution to conduct expert evaluation of quality,
- notify the applicant of the decision in writing.

2. Decision of the competent federal executive authority (MoH) upon a task to the expert institution to conduct expert evaluation of quality.

The term is not established by law, but it can take some time.

3. Submission of drug substance samples to the expert institution.

This step takes 15 work days. Another 3 wokdays are needed for notifying the competent federal executive authority. These terms are not included in expert evaluation.

4. Expert evaluation of the drug substance quality

According to paragraph 2 of article 34 of the Federal Law "On drug" for

- expert evaluation of quality,
- forming an opinion,
- submission of the opinion to the competent federal executive authority (MoH)

60 workdays following the receipt of the task are necessary.

5. Submission of the opinion of the expert committee on the results of the expert evaluation of the drug substance quality to the competent federal executive authority.

The term is not established by law, but it can take some time.

6. Inclusion of a drug substance in the State register of drugs.

Within 5 workdays following the receipt of the opinion of the expert committee on the results of the expert evaluation of the drug substance quality, the competent federal executive authority shall:

- review the opinion,- decide upon inclusion or refusal to such an inclusion of the drug substance in the State register of drugs,
- include the drug substance in the State register of drugs,
- notify thereof the applicant in writing.

Therefore, the term for the inclusion of a drug substance in the State register of drugs is 88 workdays or about 4 months (approximately 85 to 87 workdays) according to the Federal Law “On drugs”.