Article 30. Amendments to Documents Contained in Registration Dossier for Registered Medicinal Product for Medical Use

1. To enter amendments to the documents contained in the registration dossier for a registered medicinal product for medical use, the applicant shall submit to the authorized federal executive body an application for such amendments in the form prescribed by the authorized federal executive body, together with the amendments to such documents as enclosed, as well as documents certifying the necessity of such amendments. Approval of such amendments, or refusal to enter such amendments shall be given within the period not exceeding ninety business days from the date of receipt by the authorized federal executive body of an application for such amendments.

2. In case of amendments to the Package Leaflet for a medicinal product with respect to the data specified in Items d-o,u of Sub-clause 16 of Clause 3 of Article 18 hereof or changes in the composition of a medicinal product for medical use, changing the place of production of medicinal product for medical use, changing the qualitative indicators of the medicinal product for medical use and (or) the methods of quality control of the medicinal product for medical use, changing the expiry date of the medicinal product for medical use, expert examination of the medicines, in particular expert examination of the quality of the medicine and (or) expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product shall be carried out. In case of necessity to enter other amendments to such directions, no expert examination of the medicine for the purpose of such amendments to the data on such registered medicinal product shall be carried out.
(as amended by Federal Laws of October 11, 2010, of November 29, 2010, No. 313-FZ)

3. Together with an application for amendments to the documents contained in the registration dossier for a registered medicinal product for medical use, besides the documents specified in Clause 1 of this article, the documents certifying payment of the state duty for amendments to the Package Leaflet for the medicinal product for medical use or the documents certifying payment of the state duty for change in the composition of the medicinal product for medical use shall be enclosed.

4. Within ten business days upon the date of receipt of the application specified in Clause 1of this article and necessary documents, the authorized federal executive body shall:

1) examine the data contained in the materials submitted by the applicant for completeness and reliability;
2) take a decision on whether to carry out or refuse carrying out expert examinations of the medicine specified in Clause 2 of this article;
3) notify the applicant in writing of the positive decision or, in case of refusal to carry out a relevant expert examination of the medicine, or the grounds for such refusal.

5. Failure to submit a complete set of the documents listed in Clauses 1 and 3 of this article, or submission of the documents lacking comprehensive data confirming the necessity of such amendments is considered grounds for refusal to carry out expert examinations specified in Clause 2 of this article.

6. Expert examinations specified in Clause 2 of this article shall be carried out in the manner prescribed in Article 23 hereof.

7. Within the period not exceeding five business days from the date of receipt of the conclusions issued by the expert commission based on the results of expert examinations specified in Clause 2 of this article, the authorized federal executive body shall:

1) take a decision on whether to approve or refuse approving amendments to the documents contained in the registration dossier of the registered medicinal product for medical use;
2) make necessary changes in the state register of medicines based on the decision on amendments to the documents contained in the registration dossier for the registered medicinal product for medical use, and return them to the applicant.

8. Conclusion of the authorized federal executive body on possible downgrading of safety, quality and efficacy of the medicine in case of such amendments is considered grounds for refusal to approve amendments to the documents contained in the registration dossier for the registered medicinal product for medical use.

9. Civil circulation of medicinal products for medical use manufactured earlier than a decision on approval of or refusal to approve amendments to the documents contained in the registration dossier for such medicinal products has been taken by the authorized federal executive body shall be allowed.