Page 23 of 26
Article 34. Quality Evaluation of Pharmaceutical Substance not used in Manufacturing of Medicinal Products
1. Any pharmaceutical substance not used in manufacturing of medicinal products requires quality evaluation before it is included in the state register of medicines.
2. Quality evaluation of the pharmaceutical substance referred to in Clause 1 of this Article shall be carried out, expert opinion based on the evaluation findings shall be prepared and submitted to the authorized federal executive body within sixty business days of receipt by the expert institution of the relevant assignment issued by the authorized federal executive body and the documents specified in sub-clauses 4 – 7 of Clause 3 of Article 18 of this Federal Law.
3. For the purpose of quality evaluation of the pharmaceutical substance referred to in Clause 1 of this Article, the applicant shall submit to the authorized federal executive body:
1) an application for including medicines of this pharmaceutical substance into the state register; 2) a document to confirm payment of state duty for the inclusion of the pharmaceutical substance not used in manufacturing of medicinal products in the state register of medicines; 3) documents specified in Sub-clauses 4 - 7 of Clause 3 of Article 18 of this Federal Law.
4. Within five business days upon filing the application for including the pharmaceutical substance referred to in Clause 1 of this Article in the state register of medicines and documents enlisted in Part 1 and Item 2 of Part 3 of this article, the authorized federal executive body shall:
1) make sure that the data contained in the documents submitted by the applicant is complete; 2) decide to assign a task to the expert institution to carry out quality evaluation of the pharmaceutical substance referred to in Clause 1 of this Article or reject such assignment; 3) notify the applicant in writing of a positive decision or, in the event of a negative decision, give the reasons of such rejection.
5. Failure to provide any of the documents listed in Clause 2 and Sub-clause 2 of Clause 3 of this Article will be a reason for rejection of quality evaluation of the pharmaceutical substance specified in Clause 1 of this Article by the expert institution.
6. Within fifteen business days of receipt of the decision made by the authorized federal executive body to assign quality evaluation of the pharmaceutical substance specified in Clause 1 of this Article to the expert institution, the applicant shall provide the expert institution with samples of the pharmaceutical substance in the quantity as may be necessary for realization of quality control methods. On receipt of samples of the pharmaceutical substance referred to in Clause 1 of this Article, the expert institution shall issue to the applicant a documentary proof of receipt of the samples and notify the authorized federal executive body in writing within three business days. This term is not included in the term for the quality evaluation.
7. The documents submitted to the expert institution for quality evaluation of the pharmaceutical substance referred to in Clause 1 of this Article shall be returned to the authorized federal executive body together with the expert opinion.
8. Within five business days of receipt of the expert opinion on the pharmaceutical substance referred to in Clause 1 of this Article, the authorized federal executive body shall:
1) study this expert opinion to make sure that it complies with the expert assignment; 2) decide on including the pharmaceutical substance referred to in Clause 1 of this Article in the state register of medicines or reject such inclusion; 3) if it is decided to include the pharmaceutical substance referred to in Clause 1 of this Article in the state register of medicines as specified in Sub-clause 2 of Clause 1 of Article 33 hereof, add the necessary information and notify the applicant in writing.
|