Article 31.  Amendments to Documents Contained in Registration Dossier for Registered Medicinal Product for Veterinary Use

1. To enter amendments to the documents contained in the registration dossier for a registered medicinal product for veterinary 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 or refusal to approve 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 for veterinary use with respect to any data related to changes in the dosage rates or terms of possible use of animal products after the animal has been administered the medicine for veterinary use, expert examination of the medicine for veterinary use shall be carried out. In case of necessity to make other amendments to such a Package Leaflet, expert examination of the medicine for veterinary use shall not be carried out.

3. Together with an application for amendments to the documents contained in the registration dossier for a registered medicinal product for veterinary 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 a medicinal product for veterinary use shall be enclosed.

4. Within the period not exceeding 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 examination of the medicine for veterinary use;
3) notify the applicant in writing of a positive decision or, in case of refusal to carry out expert examination of the medicine for veterinary use, of 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 examination of the medicine for veterinary use.

6. Expert examination of a medicine for veterinary use for the purpose of entering amendments to the documents contained in the registration dossier for the registered medicinal product for veterinary use shall be carried out in the manner prescribed in Article 24 hereof.

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

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