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DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of November 3, 2016 No. 80

About approval of Rules of proper distributor practice within the Eurasian Economic Union

Astana

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, article 11 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Item 85 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 the Decision of the Supreme Eurasian economic council of December 23, 2014 "About implementation of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union" Council of the Eurasian economic commission solved No. 108:

1. Approve the enclosed Rules of proper distributor practice within the Eurasian Economic Union.

2. The rules approved by this Decision become effective after 1 year 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 drug circulation within the Eurasian Economic Union of December 23, 2014.

3. 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 drug circulation 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 

A. Mamin 

From the Kyrgyz Republic 

O. Pankratov 

From the Russian Federation 

I. Shuvalov

Approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 80

Rules of proper distributor practice within the Eurasian Economic Union

I. General provisions

1. These rules are part of system of quality assurance and establish rules concerning distribution of medicines.

2. Requirements of these rules are applied to all persons participating in distribution of medicines according to the functions which are carried out by them including distributors and producers of medicines, irrespective of departmental accessory and pattern of ownership.

The purpose of proper distributor practice is observance of proper storage conditions, transportations and the distribution necessary for quality assurance, safety and efficiency of medicines on all supply chain, and also prevention of risk of penetration of counterfeited medicines into supply chain.

Observance of requirements of these rules will provide control of supply chain and will allow to keep quality and integrity of medicines.

3. State members of the Eurasian Economic Union (further respectively – state members, the Union) have the right to adopt the regulatory legal acts which are regulating separate stages of distribution of medicines and not contradicting these rules (for example, stages of distribution of the medicines carried to groups of narcotic, psychotropic medicines or their precursors, the medicines carried to group of especially toxic (highly toxic) compounds, the medicines which are sources of ionizing radiation).

II. Determinations

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

"validation" – documentary drawn up actions proving that the procedure, process, the equipment, material, transaction or system conform to the set requirements and their use will constantly result in results, the corresponding predefined eligibility criterions;

"return" – sending medicines to the producer or the distributor irrespective of whether these products have defect of quality;

"distributor" – the organization of wholesale having the allowing document for distribution implementation, including for storage and transportation of medicines, and performing activities for their distribution;

"distribution" – the activities connected with purchase (purchase, acquisition), storage, import (import), export (export), realization (except for realization to the population) without restriction of amounts and transportation of medicines;

"zone" – the room or part of the rooms which are specially intended for accomplishment of different functions;

"quality" – set of the properties and characteristics of medicine influencing its capability to be effective to destination;

"qualification" – documentary drawn up actions certifying and confirming that the equipment or auxiliary systems are mounted properly correctly function and really result in the expected results;

"proper distributor practice" – the part of system of quality assurance guaranteeing quality of medicines throughout all stages of supply chain including storage and transportation, from the producer to the subjects performing production, wholesale, retail sale or leave to the population of medicines including the organizations performing medical activities;

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