DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of November 3, 2016 №84

About procedures for forming and maintaining the unified register of the registered medicines of the Eurasian Economic Union and information databases in the field of drug circulation

Astana

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, article 14 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Item 102 of appendix № 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 № 98, and the Decision of the Supreme Eurasian economic council of December 23, 2014 № 108"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 decided :

1. Approve enclosed:

Procedure for forming and maintaining the unified register of the registered medicines of the Eurasian Economic Union;

Procedure for forming and maintaining the single information database of the medicines which are not conforming to quality requirements and also the counterfeited and (or) counterfeit medicines revealed in the territories of state members of the Eurasian Economic Union;

Procedure for forming and maintaining the single information database on undesirable reactions (actions) to medicines, including messages on inefficiency of medicines, revealed in the territories of state members of the Eurasian Economic Union;

Procedure for forming and maintaining the single information database on the medicines with the suspended registration certificates withdrawn from the market or prohibited to medical application in the territories of state members of the Eurasian Economic Union.

2. 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.

Approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 №84

Procedure for forming and maintaining the unified register of the registered medicines of the Eurasian Economic Union

1. This Procedure is developed according to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, article 14 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014 and determines the procedure of forming and maintaining the unified register of the registered medicines of the Eurasian Economic Union (further – the unified register).

This Procedure is developed for the purpose of ensuring single accounting of the medicines registered according to the procedure, established by the Eurasian economic commission (further – the Commission), and provisions to the unrestricted group of people of data on the medicines released in the total market of the Eurasian Economic Union (further – the Union).

For the purposes of this Procedure the concepts given in rules of registration and examination of the medicines for medical application approved by the Commission are used (further – rules of registration and examination of medicines).

2. The unified register is the general information resource containing data on the medicines registered according to rules of registration and examination of medicines, created with use of means of the integrated information system of the Union (further – the integrated system) on the basis of information exchange between authorized bodies (the expert organizations) of state members of the Union in the field of drug circulation (further respectively – authorized bodies (the expert organizations), state members), and also between authorized bodies (the expert organizations) and the Commission.

3. The unified register is created and kept by the Commission on the basis of the data represented in electronic form by authorized bodies (the expert organizations) according to rules of registration and examination of medicines.

4. Information exchange between authorized bodies (the expert organizations), and also between authorized bodies (the expert organizations) and the Commission in the course of forming, maintaining and use of the unified register is performed by realization of the corresponding general process within the Union by means of the integrated system.

5. Forming and maintaining the unified register include:

1) obtaining by the Commission from authorized bodies (the expert organizations) of urgent data on the medicines which were registered according to rules of registration and examination of medicines;

2) inclusion by the Commission of the data provided by authorized bodies (the expert organizations) in the unified register;

3) publication by the Commission of the data containing in the unified register on information portal of the Union on the Internet;

4) updating by the Commission of the data containing in the unified register;

5) storage of the data containing in the unified register;

6) provision of access to the data containing in the unified register.

6. Authorized bodies (the expert organizations) bear responsibility for reliability of the data represented for inclusion (updating) in the unified register.

7. The unified register contains the following data:

1) 6-unit sequence number of the registration certificate of medicine created in the integrated system at the request of authorized body (the expert organization) of the reference state and appropriated by the reference state;

2) names of the reference state, states of recognition (in the presence);

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