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DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of November 3, 2016 № 74

About approval of the Procedure for forming and maintaining the register of authorized persons of producers of medicines of the Eurasian Economic Union

Astana

According to article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014, Item 2 of article 9 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Item 89 of appendix №1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Euroasian 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 the enclosed Procedure for forming and maintaining the register of authorized persons of producers of medicines 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.

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 №74

Procedure for forming and maintaining register of authorized persons of producers of medicines of the Eurasian Economic Union

I. General provisions

1. This Procedure is developed for the purpose of implementation of article 30 of the Agreement on the Eurasian Economic Union of May 29, 2014 and Item 2 of article 9 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014 and determines rules of forming and maintaining the register of authorized persons of producers of medicines of the Eurasian Economic Union.

2. The concepts used in this Procedure mean the following:

"register" – the general information resource containing data on authorized persons of producers of medicines of state members of the Eurasian Economic Union, created with use of the integrated information system of the Eurasian Economic Union on the basis of information exchange of state members of the Eurasian Economic Union and the Eurasian economic commission;

"authorized person" – the authorized person of the producer of medicines of state member of the Eurasian Economic Union, level of professional education and which length of service conform to qualifying standards and which is certified on the right of implementation of functions of the authorized person of the producer of medicines according to the international treaties and acts constituting the right of the Eurasian Economic Union.

3. The purpose of forming and maintaining the register are accounting and systematization of data on authorized persons.

4. The register is created and kept by the Eurasian economic commission (further – the Commission) on the basis of the data represented by authorized bodies of state members of the Eurasian Economic Union, in electronic form in the Commission, in the sphere of drug circulation (further respectively – authorized bodies, state members, the Union).

5. Information exchange between authorized bodies and the Commission in the course of forming and maintaining the register is performed by realization of general process within the Union by means of the integrated information system of the Union (further – the integrated system).

6. Forming and maintaining the register include obtaining by the Commission from authorized bodies of urgent data on the authorized persons certified by them, storage, publication of data of the register on information portal of the Union on the Internet, and also provision of access to data of the register to the interested authorized bodies with use of means of the integrated system.

7. Authorized bodies bear responsibility for reliability of data on the authorized persons represented for entering into the register.

8. Maintaining the register is performed in Russian.

II. The scope of information, containing in the register

9. The register contains the following subjects to publication of the data on the authorized person:

a) the name of the state member which included data in the register;

b) surname, name, middle name (in the presence);

c) contact data: phone number and fax, e-mail address (in the presence);

d) data on availability of higher education;

e) the name of specialty according to the diploma about education;

e) data on academic degree (in the presence);

g) data on place of employment:

the complete and reduced names of the legal entity according to the constituent document with indication of form of business and the unique identifier of the legal entity in the register of legal entities of state member;

address of implementation of activities of the legal entity;

contact data: phone number and fax, e-mail address (in the presence) legal entity;

h) data on the document confirming decision making about certification of the authorized person: number, the name of the document and date of its issue, the name of the authorized body which issued the document;

i) start date of implementation of activities as the authorized person;

j) type of productive activity on which implementation the document confirming decision making about certification of the authorized person is issued;

k) end date of implementation of activities as the authorized person or date of cancellation of the decision on certification of the authorized person.

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