The basic principles of the functioning of the common market for medical products and medicines of the Eurasian Economic Union were presented at NCE

At the site of "Atameken" was held a "round table discussion on the topic "The Common Market of medical products and medicines of the Eurasian Economic Union: consultations and clarification on the operation".

Employees of RSE "National center of examination of medicines, medical devices and medical equipment" told the representative of the domestic business in the field of medical devices and medicinal products about the basic principles of functioning of the common market for medical products and medicines of the Eurasian Economic Union.

It is worth noting that employers actively expressed interest in a more detailed and in-depth understanding of the new "rules of the game on the big stage". Several questions were raised concerning the characteristics of the registration of medical devices and medicines for the newly adopted Regulation of EAEU, opportunities for support domestic business and readiness of the Kazakhstani laboratory and diagnostic facilities to conduct the required research.

Acting Chairman of the Committee for Control of medical and pharmaceutical activity of the Ministry of Health of RK L. Pak has provided satisfactory answers, as well as shared with the audience information about the upcoming close cooperation of MHSD and RSE with domestic manufacturers in the selection of the Republic of Kazakhstan as a reference state.

"The Ministry of Health in any case is not interested in the fact that applicants who choose us (i.e. Kazakhstan) as a reference state, tomorrow could not go through the recognition procedure in other countries of the Union, or they had any difficulties with the Eurasian Economic Commission. In each such case, we will appoint a competent officer of MHSD and RSE to defend our interests of the applicant, and the authority of our ministry and the state in the eyes of the countries - participants of the EAEU. Do not doubt, we are on the same side", - she said at the end of the meeting.

Department of economic integration of NCE RK "Atameken", in turn, noted the need for similar activities, aimed at clarifying the common features of the market of medical devices and drugs on a regular basis, with the involvement of the maximum range of domestic producers.

All presentation materials presented within the framework of the "round table", as well as additional information DEI of NCE, are presented on the official Internet website of the Chamber at www.palata.kz.

To the attention of entrepreneurs

On 16^th of November  2016 at a meeting of the Eurasian Intergovernmental Council was signed a package of common documents, required to start and complete the work in common medicines market (hereinafter - the Common Market) on the territory of the Eurasian Economic Union (hereinafter - the EAEU, Union).

The first step towards a common market became Article 30 of the EAEU Treaty, according to which the member - states create within the Union a common market of medicinal products corresponding to the standards of good pharmacy practice and based on common principles.

Based on this, one of the first agreements signed within the framework of the Treaty was an agreement on common principles and rules of drug circulation in the framework of the Eurasian Economic Union dated by 23^rd of December 2014 (hereinafter - the Agreement). The agreement was ratified in accordance with the law of the Republic of Kazakhstan dated by 12^th of October 2015.

In practice, the common market should allow easier drug circulation procedures between the member - states of the Union, bringing the basic criteria and indicators to a common denominator.

To that end was adopted a package of documents, which stipulates such basic directions for the pharmaceutical industry, as:

- Uniform standards for production and quality control;

- Uniform procedure for registration of medicines;

- A single register of authorized medicinal products;

- Common requirements for the labeling of medicinal products;

- Uniform requirements for the instruction for medical use of drugs;

- Harmonization of the State Pharmaceutical companies of member-states and others.

Registration of medicinal products within the Union is held according to Rules of registration and examination of drugs for medical use, approved by the decision of the Eurasian Economic Commission Council on 3^rd of November 2016 #78.

In accordance with the Rules, the registration of drugs is carried out by a consistent procedure (mutual recognition procedure), or the simultaneous procedure (decentralized registration procedure).

Mutual recognition procedure involves drug registration in two stages:

• National registration procedure - the reference state registers for the purposes of finding the drug on the market of that state;
• the procedure of mutual recognition - by the applicant's request the drug can be recognized in other member - states of the Union (the recognition states).

Registration of the drug by the decentralized procedure is also carried out in two stages, which are carried out simultaneously:

• registration in the reference state;
• recognition of expert evaluation report in the recognition states.

However, the following items are not subject to the procedure for registration of medicines in the framework of the EAEU:

- Drugs made in pharmacies;

- Pharmaceutical substances;

- Drugs for use as display samples;

- Medicinal products intended for preclinical and clinical trials (tests);

- Medicinal products imported by an individual for personal use;

- Radiopharmaceutical drugs, made directly at medical institutions in the manner prescribed by the competent authorities of the Member States;

- Medicinal products, which are not intended for sale at the customs territory of the Union;

- Samples of medicines intended for registration, and reference materials.

Manufacturing of pharmaceuticals by member-states of the EAEU should be done only upon compliance with good manufacturing practice (Good Manufacturing Practice, GMP), reflecting a holistic approach to assessment of the parameters of production and laboratory testing.

The competent authorities of the parties have reached an agreement on mutual recognition of GMP certificates issued by the countries - members of the Union. However, it provides for the possibility of inspection of conformity of production to good practices of EAEU.

The legal basis for the EAEU in the field of drugs provides for a transitional period until 31^st of December 2025.

The common market of medical products

The point of legal reference in the creation of a common market of medical devices of the Union was the article 31 of the Treaty on the EAEU, on the basis of which the parties have adopted the Agreement on common principles and rules of circulation of medical product (medical devices and medical equipment) in the framework of the Eurasian Economic Union on 23^rd of December, 2014.

The common market of medical devices should enable to create a common space of circulation of medical products of the Union, subject to the general requirements and operating on the same principles.

According to the documents of the second level, namely Decision of the Council of EEC dated by12th of February 2016 number 46, it provides for the registration of medical devices via the serial procedure - chosen by the applicant in the reference country and the subsequent registration in countries of acceptance.

To initiate the procedure, it is necessary to submit the following documents to the authorized body of the referent country:

• Application for the examination and registration of MP;
• Registration of a dossier;
• Copies of the documents, confirming the payment for the registration and expertise of MP.

The document confirming the fact of registration of the MP, is the registration certificate of the established form with indefinite duration.

However, it provides a number of conditions under which the release of medical products in circulation within the Union is prohibited: there is a formal notification of the authorized body, the producer and (or) his authorized representative that the circulation of MP is suspended or withdrawn from circulation or withdrawn by the manufacturer;

• MP expired (shelf life);
• MP is not registered in the prescribed manner.

The reference of quality of medical products of EAEU is compliance with the condition of ISO 13485: 2003, containing the requirements for a quality management system of manufacturers of medical products.

The quality management system must ensure compliance of the medical product to general safety and efficacy requirements applied to stages (stages) of the life cycle:

• Design,
• Development,
• Production,
• Control of output,
• Processes associated with the consumer.

The package of documents on regulation of circulation of medical products on the territory of the Union, testifying to the fact that medical product has passed the registration procedure and the conformity with the general requirements of safety and efficacy of MP and the requirements for implementing and maintaining quality management systems within the Union.

The public authorities of countries - participants of the Union exercise control and monitoring, including collection, registration, analysis of information on adverse events (incidents) and the adoption of appropriate decisions.

Legal framework of EAEU for a common market of medical devices also has a transition period and the registration documents issued by the competent authority of the member state act on the territory of that State until the expiry of their validity but not later than 31^st of December 2021.

Presentation materials, containing more detailed information on the functioning of the common market of medicinal products and medical devices of EAEU, prepared by NCE RK "Atameken", can be found here.