On the ratification of the Agreement on Common Principles and Rules for the Circulation of Medicines within the Framework of the Eurasian Economic Union

Home / RLA / On the ratification of the Agreement on Common Principles and Rules for the Circulation of Medicines within the Framework of the Eurasian Economic Union

The Law of the Republic of Kazakhstan dated October 12, 2015 No. 355-V SAM.

To ratify the Agreement on Common Principles and Rules for the Circulation of Medicines within the Framework of the Eurasian Economic Union, signed in Moscow on December 23, 2014.

President

Republic of Kazakhstan

N. NAZARBAYEV

THE AGREEMENT on Common Principles and Rules for the Circulation of Medicines within the Framework of the Eurasian Economic Union Entered into force on February 12, 2016 - Bulletin of International Treaties of the Republic of Kazakhstan 2016, No. 2, art. 35

The member States of the Eurasian Economic Union, hereinafter referred to as the Member States,

based on the Treaty on the Eurasian Economic Union of May 29, 2014,

Confirming their intention to develop economic cooperation and expand trade and economic ties,

Recognizing that medicines are socially significant products,

in order to form a common market for medicines within the framework of the Eurasian Economic Union (hereinafter referred to as the Union),

Aiming at improving the health of the population of the Member States by ensuring access to safe, effective and high-quality medicines,

Recognizing the expediency of conducting a coordinated policy in the field of drug circulation, taking into account mutual interest in ensuring the safety, effectiveness and quality of medicines for human life and health, environmental protection, animal and plant life and health, and the prevention of actions misleading consumers,

Striving to create optimal conditions for the development of the pharmaceutical industry, increase the competitiveness of pharmaceutical products manufactured in the territories of the Member States, and enter the global market,

Striving to eliminate unjustified restrictions in mutual trade,

have agreed on the following:

Article 1 Definitions

1. For the purposes of this Agreement, concepts are used that mean the following::

"medicinal product" means a product that is or contains a substance or combination of substances that comes into contact with the human body, intended for the treatment, prevention of human diseases or the restoration, correction or modification of its physiological functions through pharmacological, immunological or metabolic effects or for the diagnosis of human diseases and conditions;

"medicinal product" - a medicinal product in the form of a dosage form;

"Good pharmaceutical practices in the field of drug circulation" (hereinafter referred to as good pharmaceutical practices) are rules that apply to all stages of drug circulation: good laboratory practice, good clinical practice, good manufacturing practice, good distribution practice, good pharmacy practice, good pharmacovigilance practice and other practices;

"circulation of medicinal products" is an activity involving the processes of development, preclinical research, clinical trials (trials), examination, registration, pharmacovigilance, quality control, production, manufacture, storage, transportation, importation into the customs territory of the Union and export from the customs territory of the Union, movement from the territory of one member state to the territory of others of the Member States, the release, sale, transfer, use, destruction of medicines;

"pharmaceutical substance" is a medicinal product intended for the production and manufacture of medicinal products.

2. When forming a common market for medicines within the Union, the Member States are guided by unified concepts and their definitions in accordance with the information directory of concepts and definitions in the field of circulation of medicines, the formation and maintenance of which is carried out by the Eurasian Economic Commission (hereinafter - the Commission).

Article 2 Scope of the Agreement

1. This Agreement establishes common principles and rules for the circulation of medicines within the Union in order to form a common market for medicines within the Union.

2. This Agreement applies to Legal Relations arising in the field of circulation of medicines in circulation within the Union.

Article 3 Regulation of the circulation of medicinal products

1. The regulation of the circulation of medicines within the Union is carried out in accordance with this Agreement, other international treaties included in the law of the Union, decisions of the Commission and the legislation of the Member States.

The Commission's decisions regulating the circulation of medicines are developed on the basis of international standards.

2. The Member States shall send proposals to the Commission regarding the development of draft acts of the Union's bodies in the field of circulation of medicines.

3. In order to ensure compliance with the requirements in the field of circulation of medicines within the Union, the Commission has the right to make recommendations regarding the definition of optimal approaches, the implementation of which will ensure compliance with such requirements.

Article 4 Functioning of the common market of medicines within the Union

1. The Member States shall form a common market for medicines that meet the requirements of good pharmaceutical practices, in accordance with the principles specified in Article 30 of the Treaty on the Eurasian Economic Union of May 29, 2014.

2. The Member States shall implement a coordinated policy in the field of drug circulation by:

a) taking measures necessary for the harmonization and unification of the legislation of the Member States in the field of circulation of medicines;

b) adoption of uniform rules and requirements for regulating the circulation of medicines;

c) ensuring the uniformity of mandatory requirements for the safety, efficacy and quality of medicines in the territories of the Member States and their compliance;

d) ensuring uniform approaches to the creation of a quality assurance system for medicines;

e) harmonization of the legislation of the Member States in the field of control (supervision) in the field of circulation of medicines.

3. For the purposes of implementing this Agreement, the Member States shall designate public authorities authorized to carry out and (or) coordinate activities in the field of drug circulation.

4. The coordination of activities aimed at the harmonization of the legislation of the Member States in the field of circulation of medicines is carried out by the Commission.

5. The public authorities of the Member States referred to in paragraph 3 of this Article shall conduct consultations aimed at coordinating the positions of the Member States on the regulation of the circulation of medicines.

Article 5 Harmonization of the State pharmacopoeias of the Member States

1. The Member States shall take measures to establish the pharmacopoeial requirements of the Union by consistently harmonizing the pharmacopoeial articles (general and private) of the State pharmacopoeias of the Member States.

2. The harmonization of the state pharmacopoeias of the Member States is carried out using international experience in the harmonization of national pharmacopoeial requirements in accordance with the concept approved by the Commission.

3. The Pharmacopoeia articles (general and particular) approved by the Pharmacopoeia Committee of the Union collectively form the Pharmacopoeia of the Union, which is approved by the Commission.

4. The private pharmacopoeia articles of the Pharmacopoeia of the Union, which establish quality requirements for medicines intended for circulation within the Union, are developed in accordance with the concept specified in paragraph 2 of this Article.

5. The procedure for the activities of the Pharmacopoeia Committee of the Union is determined by the Commission.

6. For the purposes of registration and quality control of medicines intended for circulation only in the territory of a particular Member State, the requirements of the State pharmacopoeia of that Member State apply.

Article 6 Preclinical and clinical studies (trials) in the Member States

In order to ensure the functioning of the common market for medicines within the Union, preclinical and clinical research (trials) of medicines in the Member States are conducted in accordance with the rules of good laboratory practice, rules of good clinical practice and requirements for conducting research (trials) of medicines approved by the Commission.

Article 7 Registration and examination of medicinal products

1. The Member States shall register and examine medicinal products intended for circulation on the common market of medicinal products within the Union in accordance with the rules for registration and examination of medicinal products approved by the Commission.

2. The requirements for the structure, format, content of the registration dossier, the structure and content of the evaluation report of the registration dossier, the form of the registration certificate of the medicinal product, the procedure for making changes to the registration dossier, the grounds for refusal of registration, revocation, suspension or termination of the registration certificate of the medicinal product are established in the rules specified in paragraph 1 of this article.

3. When registering and examining medicines, Member States use the nomenclature of dosage forms approved by the Commission.

4. Registration under the same trade name of medicines having different qualitative composition of active substances is prohibited.

5. Member States shall not allow their legislation to establish the re-registration of medicines registered in their territory in accordance with the rules for registration and examination of medicines approved by the Commission.

6. They are not subject to registration within the Union.:

a) medicines manufactured in pharmacies;

b) pharmaceutical substances;

c) medicinal products intended for use as exhibition samples;

d) medicinal products intended for preclinical and clinical studies (trials);

e) medicines imported by an individual for personal use;

f) radiopharmaceutical medicinal products manufactured directly in medical organizations in accordance with the procedure established by the authorized bodies of the Member States;

g) medicinal products not intended for sale in the customs territory of the Union;

h) samples of medicines intended for registration and standard samples.

7. When carrying out the registration and examination procedure for medicinal products, the Member States mutually recognize the results of preclinical (non-clinical), clinical and other studies (trials) of medicinal products, the results of production inspection, preclinical (non-clinical), clinical studies (trials) of medicinal products, pharmacovigilance systems for compliance with the rules of good pharmaceutical practices, as well as the requirements approved by By commission.

The Member States shall create conditions for conducting research (trials) of medicines in accordance with international standards and ensure comparability of their results.

8. Disputes arising during the registration of medicinal products are settled by the Expert Committee on Medicinal Products (hereinafter referred to as the Expert Committee), established under the Commission from representatives of the Member States and operating in accordance with the procedure approved by the Commission.

9. The decision of the authorized body of a Member State to refuse to issue a registration certificate for a medicinal product may be appealed to the court of that Member State in accordance with the procedure provided for resolving disputes arising from administrative and other public legal relations.

Article 8 Sale of medicines

1. Medicines may be sold within the Union, provided that they have been registered in accordance with the procedure established by the Commission, and information about them has been entered into the unified register of registered medicines of the Eurasian Economic Union.

2. Medicinal products registered by the authorized body of a Member State prior to the entry into force of this Agreement shall be sold on the territory of that Member State until the expiration of the validity period of registration certificates issued by the authorized body of the Member State.

3. Medicines registered in accordance with Article 7 of this Agreement and marketed within the Union must be labeled in accordance with the uniform labeling requirements for medicines approved by the Commission, and they must be accompanied by instructions for use that comply with the uniform requirements for instructions for the medical use of medicines approved by the Commission.

Article 9 Manufacture of medicinal products

1. The production of medicines within the Union is carried out in accordance with the rules of good manufacturing practice approved by the Commission, on the basis of a permit (license) for the production of medicines issued in accordance with the legislation of the Member States.

2. The authorized person of the manufacturer of medicines must be certified by the authorized body of the Member State in accordance with the procedure for certification of authorized persons of manufacturers of medicines approved by the Commission. Certified authorized persons of manufacturers of medicines are included in the register of authorized persons of manufacturers of medicines of the Eurasian Economic Union, which is formed and maintained by the Commission in accordance with the procedure approved by the Commission.

3. In case of improper performance of their duties, authorized persons of pharmaceutical manufacturers are liable in accordance with the legislation of the Member States.

Article 10 Pharmaceutical inspections

1. Pharmaceutical inspections are carried out both by pharmaceutical inspectorates of one of the Member States and jointly by pharmaceutical inspectorates of the Member States in accordance with the rules determined by the Commission. Based on the inspection results, an inspection report is prepared in the form approved by the Commission.

2. Pharmaceutical inspectorates of the Member States shall carry out their activities in accordance with the general requirements approved by the Commission.

3. Pharmaceutical inspectorates of the Member States shall cooperate with each other in order to exchange experience, maintain and improve the quality assurance system for medicines and the quality system of pharmaceutical inspectorates, and ensure the participation of pharmaceutical inspectors in events (including those conducted by the World Health Organization and other international organizations) aimed at improving their skills.

4. The Commission, taking into account the proposals of the member States, maintains a register of pharmaceutical inspectors of the Eurasian Economic Union. The formation and maintenance of the specified register is carried out in accordance with the procedure approved by the Commission.

5. The activities of the pharmaceutical inspectorates of the Member States are ensured by the Member States.

Article 11 Wholesale sale, transportation and storage of medicines

The wholesale sale, transportation and storage of medicines in the territories of the Member States are carried out in accordance with the rules of good distribution practice approved by the Commission.

Article 12 Pharmacovigilance

1. The Member States shall ensure the effective functioning of the national pharmacovigilance system in accordance with good pharmacovigilance practices approved by the Commission and the legislation of the Member States.

2. The Member States shall establish in their legislation provisions on the liability of holders of registration certificates of medicinal products and other subjects of circulation of medicinal products that violate mandatory requirements in the field of pharmacovigilance.

3. The authorized bodies of the Member States ensure that holders of registration certificates of medicines in circulation in the territories of the Member States comply with their pharmacovigilance obligations in accordance with good pharmacovigilance practices and legislation of the Member States.

4. Information on identified adverse reactions (actions) to medicines, changes in the assessment of the benefit-risk ratio of medicines in circulation in the territories of the Member States, and measures taken when the risk exceeds the benefit shall be exchanged between the authorized bodies of the Member States in accordance with the procedure approved by the Commission.

5. The Expert Committee examines cases of divergence in the positions of Member States on the issue of assessing the benefit-risk ratio of medicines in circulation in the territories of the Member States.

6. The Member States shall exchange information on the results of inspections of the pharmacovigilance system of the holder of the registration certificate of a medicinal product in order to determine their compliance with the legislation of the Member States.

Article 13 State control (supervision) over the circulation of medicines

1. The Member States shall exercise state control (supervision) over the circulation of medicinal products in accordance with the procedure established by the legislation of the Member States.

The authorized bodies of the Member States cooperate to identify counterfeit and (or) counterfeit medicines in accordance with the procedure approved by the Commission.

2. The authorized bodies of the Member States, in case of classifying medicines as ineffective, substandard, falsified and (or) counterfeit medicines that pose a danger to human life and (or) health, immediately send relevant information to the Commission and notify the authorized bodies of other Member States about this, and also take measures within their competence, ensuring the prompt withdrawal from circulation of medicines that pose a danger to human life and (or) health.

Article 14 The Unified Register of Registered Medicines of the Eurasian Economic Union and information databases in the field of circulation of medicines

In order to ensure conditions for the circulation of safe, effective and high-quality medicines in the territories of the Member States, the Commission is forming and conducting:

the unified register of registered medicines of the Eurasian Economic Union (hereinafter referred to as the Unified register) with integrated information databases of instructions for medical use, graphic design of packages and regulatory documents on quality;

a unified information database of medicines that do not meet quality requirements, as well as counterfeit and (or) counterfeit medicines identified in the territories of the Member States;

a unified information database on identified adverse reactions (actions) to medicines, including reports on the ineffectiveness of medicines;

A unified information database on suspended, recalled, and prohibited medicinal products.

The authorized bodies of the Member States shall submit to the Commission, in accordance with the procedure established by the Commission for the formation and maintenance of a unified register, the information necessary for the formation of the register and databases specified in this article.

Article 15 Information system of the Union in the field of circulation of medicines

The Commission ensures the creation and functioning of the Union's information system in the field of circulation of medicines (hereinafter referred to as the information system) in order to provide information on the requirements in the field of circulation of medicines operating within the Union, information contained in the unified register and information databases specified in Article 14 of this Agreement, as well as pharmacovigilance data and other groups of information provided by the rules for the creation and operation of an information system.

The rules for the creation and operation of an information system are approved by the decision of the Commission and determine the basis for its creation, operation and development, sources and procedure for financing.

The Commission and the authorized bodies of the Member States shall apply information systems, information technologies and their support tools developed, manufactured or acquired by them in accordance with the decisions of the Commission, the legislation of the Member States and (or) international treaties within the Union.

Article 16 Information interaction of authorized bodies of the Member States in case of taking measures restricting the circulation of medicines

The authorized body of a Member State, in cases provided for by the legislation of its state, has the right to make a decision on suspension, revocation or refusal to extend the validity period of a medicinal product registration certificate issued by it, which must be immediately informed by the authorized bodies of other Member States and the Commission.

Article 17 Cooperation of authorized bodies of the Member States

The authorized bodies of the Member States cooperate in the field of drug circulation, including by ensuring the conduct of scientific research, scientific and practical conferences, seminars and other events.

The authorized bodies of the Member States carry out activities for the exchange of experience, organization of joint training of specialists.

Article 18 Amendment of the Agreement

By mutual agreement of the Member States, amendments may be made to this Agreement, which are formalized in separate protocols and are an integral part of this Agreement.

Article 19 Dispute resolution procedure

Disputes related to the interpretation and/or application of the provisions of this Agreement are resolved in accordance with the procedure established by Article 112 of the Treaty on the Eurasian Economic Union of May 29, 2014.

Article 20 Transitional provisions

1. Medicines registered in the Member States prior to the entry into force of this Agreement must be brought into compliance with the requirements and rules of the Union by December 31, 2025 in accordance with the procedure established by the rules for registration and examination of medicines specified in Article 7 of this Agreement.

Member States shall allow confirmation of registration of medicinal products having urgent registration certificates issued before the entry into force of this Agreement, upon expiration of their validity period in accordance with the legislation of the Member State.

2. Prior to the entry into force of the Commission's decisions regulating the circulation of medicinal products, the relevant regulatory legal acts of the Member States are applied.

Article 21 Entry into force of the Agreement

1. This Agreement shall enter into force on the date of receipt by the depositary of the last written notification on the completion by the Member States of the internal procedures necessary for its entry into force, but not earlier than January 1, 2016.

2. This Agreement is an international agreement concluded within the framework of the Union and is included in the law of the Union.

Done in Moscow on December 23, 2014, in one original copy in the Russian language.

The original copy of this Agreement shall be kept at the Eurasian Economic Commission, which, as the depositary of this Agreement, will send each member State a certified copy thereof.

For the Republic of Belarus

For the Republic of Kazakhstan

For the Russian Federation

I hereby certify that this text is a complete and authentic copy of the Agreement on Common Principles and Rules for the Circulation of Medicines within the Framework of the Eurasian Economic Union, signed on December 23, 2014 in Moscow.:

for the Republic of Belarus - V.E. Shevchuk, Deputy Minister of Health and Director of the Pharmaceutical Industry Department of the Ministry of Health of the Republic of Belarus;

for the Republic of Kazakhstan — First Deputy Prime Minister of the Republic of Kazakhstan B.A. Sagintayev;

for the Russian Federation — I.I. Shuvalov, First Deputy Chairman of the Government of the Russian Federation.

The original copy is kept at the Eurasian Economic Commission.

Director

Legal Department

Of the Eurasian Economic Commission

V.I. Taraskin

President

Republic of Kazakhstan

Constitution Law Code Standard Decree Order Decision Resolution Lawyer Almaty Lawyer Legal service Legal advice Civil Criminal Administrative cases Disputes Defense Arbitration Law Company Kazakhstan Law Firm Court Cases