Article 19. Procedure for Making Decision on Issuance of Assignment for Performance of Expert Examination of Medicines for Expert Institution and Ethical Council

1. Within five business days from on receipt of an application for state registration of a medicinal product, the authorized federal executive body shall review the data contained in the materials submitted by the applicant for completeness and reliability, and take decision on issuance of an assignment to carry out:

1) expert examination of the medicines, in particular expert examination of the documents submitted to obtain a permit for the conduct of a clinical trial of the medicinal product for medical use in accordance with the objectives specified in Article 38 hereof, and ethical expert examination with respect to the medicinal products, for which clinical trials have not been conducted within the territory of the Russian Federation, based on the documents specified in Sub-clauses 1 – 9, 11 – 14 and 17 of Clause 3 and Sub-clause 1 of Clause 5 of Article 18 hereof;
2) expert examination of the medicines, in particular expert examination of the quality of the medicines and expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product for medical use with respect to the medicinal products permitted for use within the territory of the Russian Federation for over twenty years, based on the documents specified in Sub-clauses 1 – 9 and 16 of Clause 3 and Sub-clause 2 of Clause 5 of Article 18 hereof, as well as the medicinal products, for which international multicentre clinical trials have been conducted, partially within the territory of the Russian Federation, based on the documents specified in Sub-clauses 1 – 9 and 15 - 17 of Clause 3 and Sub-clause 2 of Clause 5 of Article 18 hereof;
3) expert examination of the medicine with respect to the medicinal products for veterinary use, based on the documents specified in Sub-clauses 1 – 8, 10, Items a-e, g-l and o-t of Sub-clause 16 and Sub-clause 17 of Clause 3 and Sub-clause 4 of Clause 5 of Article 18 hereof.

2. The authorized federal executive body notifies the applicant in writing of the positive decision or, in case of refusal, of the grounds for such refusal.

3. Failure to submit a complete set of the documents listed in Clauses 3 and 5 of Article 18 hereof necessary for performance of expert examinations, or submission of documents lacking a comprehensive list of necessary information is considered grounds for refusal to carry out expert examinations specified in Clause 1 of this Article.