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DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of February 12, 2016 No. 46

About Rules of registration and examination of safety, quality and efficiency of medical products

(as amended on 30-03-2023)

According to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014, Items 2 and 4 of article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014, Item 92 of appendix No. 1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 98, and for the purpose of execution of the Decision of the Supreme Eurasian economic council of December 23, 2014 "About implementation of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union" Council of the Eurasian economic commission DECIDED: No. 109

1. Approve the enclosed Rules of registration and examination of safety, quality and efficiency of medical products (further - Rules).

2. Ceased to be valid according to the Decision of Council of the Eurasian economic commission of 30.03.2023 No. 50

3. To state members till December 31, 2016:

a) approve the amount of charges (duties) or other obligatory payments provided by Rules, taking into account complexity of procedures and amount of the performed works which are carried out in the reference state and the states of recognition including in case of:

registration of medical product;

to examination of safety, quality and efficiency of medical product;

modification of the registration file of medical product;

to issue of duplicates of registration certificates;

b) determine bodies (organizations) responsible for registration implementation, modification of the registration file and other procedures connected with registration of medical products provided by Rules and to inform on it the Eurasian economic commission.

4. This Decision becomes effective after 10 calendar days from the effective date of the Protocol signed on December 2, 2015 on accession of the Republic of Armenia to the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014, but not earlier than after 10 calendar days from the date of official publication of this Decision.

Members of council of the Eurasian economic commission:

From the Republic of Armenia

V. Gabriyelyan

From the Republic of Belarus

V. Matyushevsky

From the Republic of Kazakhstan

B. Sagintayev

From the Kyrgyz Republic

O. Pankratov

From the Russian Federation

I. Shuvalov

 

Approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 46

Rules of registration and examination of safety, quality and efficiency of medical products

I. General provisions

1. These rules are developed according to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014 and Item 2 of article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014 and establish procedure for holding procedures of registration and examination of safety, quality and efficiency of medical products (further - examination), approvals of the expert opinion, settlement of disagreements concerning approval of the expert opinion, modification of the registration file (including in notifying procedure), issues of the duplicate of the registration certificate of medical product, approval of the expert opinion on the registered medical product, and also suspensions and (or) cancellations of action (cancellation) of the registration certificate of medical product within the Eurasian Economic Union (further - the Union).

Requirements of these rules can not be applied to medical products, requirement for which arises or increases in emergency situations, in the conditions of military operations, threat of spread of the new epidemic diseases constituting danger to people around in case of threat of absence or lack of medical products in the markets of state members of the Union (further - state members) in the conditions of introduction of rationing economic arrangements concerning at least one of state members. The address of such medical products in the territories of state members is regulated by the legislation of these state members during action of the specified conditions and elimination of their effects.

2. For the purposes of these rules concepts which mean the following are used:

"safety of medical products" - lack of the unacceptable risk connected with damnification of life, to health of the person, the environment;

"validation" - confirmation by means of submission of the objective certificates of fulfillment of requirements intended for specific use or use;

"verification" - confirmation on the basis of submission of objective certificates of accomplishment of the established requirements;

"the state of recognition" - state member, authorized body (the expert organization) of which performs reconciliation procedure of the expert opinion of the reference state;

"proofs of the first party" - evidential materials (documents) of the producer of medical product (the protocols of own testing (researches) including issued by test laboratories (centers) accredited in national accreditation system of state member, results of clinical use of medical product and other materials);

"the unified register of the medical products registered within the Eurasian Economic Union" - the electronic database of the medical products registered according to these rules;

"applicant" - the producer of medical product or its authorized representative;

"quality of medical product" - degree of compliance of set of properties and characteristics of medical product to the appointment established by the producer;

"medical products for diagnosis of in vitro" - any tools, devices, devices, the equipment, materials, reagents, calibrators, control materials and other products applied in the medical purposes separately or jointly, and also together with the accessories and the special software necessary for their use to destination, and information of rather physiological or pathological condition (inborn pathology, predisposition to certain clinical condition or disease) intended by the producer for use in case of the researches in vitro of samples of biological materials of the person for obtaining, compatibility of fabrics with the potential recipient, forecasting of reactions to therapeutic impacts, the choice of therapeutic means and (or) control of treatment;

"model (brand) of medical product" - the option of execution of medical product which is characterized by certain constructive technology solutions and specific measure values of its target (functional) appointment;

"accessory" - the product which is not medical product, intended by his producer for combined use with one or several medical products when using according to their appointment;

"the producer of medical product", "producer" - the legal entity or physical person registered as the individual entrepreneur responsible for the development and production of medical product making it available for use on its own behalf irrespective of is developed and made medical product by this person or from his name other person (persons), and the bearing responsibility for safety, quality and efficiency of medical product;

"production site" - territorially isolated complex intended for accomplishment of all production process of medical product or its certain stages;

"the registration file" - the set of documents and materials of the established structure represented by the applicant when holding procedures of registration and examination, approval of the expert opinion, modification of the registration file (including in notifying procedure), issues of the duplicate of the registration certificate of medical product, approval of the expert opinion on the registered medical product, cancellations of action (cancellation) of the registration certificate of medical product, and also originals and (or) copies of other documents concerning specific medical item (decisions of authorized bodies (the expert organizations), protocols of meetings of the Advisory committee on medical products under Board of the Eurasian economic commission, the documents submitted in case of settlement of disagreements, reports on results of inspection of production and so forth);

"registration certificate" - the document of single form confirming the fact of registration of medical product in the territory of one or several state members;

"registration of medical product", "registration" - the procedure of issue by authorized body of the reference state of permission to release into the stream of commerce of medical product in the territory of one or several state members;

"the reference state" - the state member chosen by the applicant, authorized body (the expert organization) of which performs registration and examination;

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