Article 16. Organization of Expert Examination of Medicines for State Registration Thereof

1. Expert examination of medicines is carried out by an expert commission under the expert institution appointed by the head thereof, under an assignment to conduct expert examination of a medicine issued by the authorized federal executive body. The head of the expert institution provides for proper performance of expert examination of medicines in compliance with the assignment issued by the authorized federal executive body, and makes arrangements for preparation of the commission’s summary conclusion. Under decision of the head of the expert institution persons not employed by that expert institution may be included on the commission as experts, if their special knowledge is necessary for performance of the expert examination, and if such experts are not available in that expert institution.

2. An expert appointed to carry our expert examination of medicines is a certified employee of an expert institution with higher medical, pharmaceutical, biological, veterinary or chemical education who carries out expert examination of medicines in the course of execution of his functions (hereinafter – the “the expert”).

3. When carrying out expert examination of medicines, the expert shall in no way depend upon the person who ordered the expert examination, the developer of the medicine or other persons interested in the results of the expert examination.

4. When carrying out an expert examination of medicines, it is not allowed to demand any materials necessary to carry out the expert examination from the applicant or other persons. In case of insufficiency of the materials submitted to an expert for him to make a conclusion, such expert is entitled to apply to the head of the expert institution for submission of necessary documents, which expert shall make a relevant request to the authorized federal executive body that issued the assignment to carry out expert examination of the medicine.

5. When carrying out expert examination of a medicine assigned to an expert by the head of the expert institution, such expert shall:

1) carry out a complete examination of the objects and materials submitted to him, issue a reasonable and objective conclusion as to the questions put to him, or a reasoned conclusion on impossibility of performance of expert examination of the medicine, should the questions put to him be beyond the expert’s competence, should the examination objects and the materials be inapplicable or not sufficient for carrying out the examination and issuance of a conclusion, or should the state-of-the-art of the science not allow responding to such questions;
2) not disclose information made available to him in connection with expert examination of a medicine, as well as information that constitutes state, trade or other secret protected by the law;
3) ensure safe keeping of examination objects and materials submitted.

6. The expert shall not be entitled to:

1) carry out expert examination of a medicine on application of any institutions or individuals directly to him;
2) independently collect materials to carry out expert examination of a medicine;
3) carry out expert examination of a medicine as a non-state expert.

7. If necessary, an expert is entitled to petition the head of the expert institution to engage other experts to carry out expert examination of a medicine.

8. Each expert included in an expert commission which is assigned to carry out expert examination of a medicine shall carry out examination independently and solely, estimate the results obtained by him personally and by other experts, and draw inferences with respect to the questions put to the commission within his competence.

9. Results of expert examination of a medicine are documented in the conclusion of the expert commission. A conclusion of an expert commission shall include the list of examinations, the volume of examinations carried out by each expert, the facts determined by each expert and the inferences based on the examination results. An expert whose opinion does not meet the decision of the expert committee is entitled to express his opinion in writing, which opinion is enclosed with the conclusion of the expert commission.

10. Experts included in an expert commission shall be forewarned of responsibility stipulated by the legislation of the Russian Federation for issuance of a conclusion containing unreasonable or falsified inferences, which responsibility they acknowledge in writing.

11. Special expert and qualification commissions determine the professional level of the experts and certify the latter for carrying out expert examination of medicines in the manner prescribed by the authorized federal executive body. The professional level of experts is subject to review by such commissions at least every five years.

12. Rules for expert examination of medicines and a form of expert commission conclusion are established by the authorized federal executive body.