APPROVED

By the decision of the Board of the

Eurasian Economic Commission
от 25 октября 2016 г. № 122

ORDER
joining the general process "Formation, maintenance
and use of a unified register of registered medicines of the Eurasian
Economic Union"

I. _ General provisions

one. This Procedure was developed in accordance with the following

acts included in the law of the Eurasian Economic Union
(hereinafter referred to as the Union) :
Treaty on the Eurasian Economic Union of May 29, 2014 ;
Agreement on uniform principles and rules for the circulation of
medicines within the framework of the Eurasian Economic Union
of December 23 , 2014 ;
Decision of the Supreme Eurasian Economic Council
of December 23 , 2014 No. 108 "On the implementation of the Agreement on
uniform principles and rules for the circulation of medicines within the
Eurasian Economic Union" ;
Decision of the Board of the Eurasian Economic Commission
dated November 6, 2014 No. 200 “On technological documents regulating
information interaction in the implementation of common processes by
means of an integrated information system for foreign and mutual trade” ;
Decision of the Board of the Eurasian Economic Commission
dated January 27, 2015 No. 5 "On approval of the Rules for electronic data
interchange in the integrated information system of foreign
and mutual trade" ;
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Decision of the Board of the Eurasian Economic Commission

dated April 14, 2015 No. 29 “On the list of common processes within the
framework of the Eurasian Economic Union and amendments to the Decision
of the Board of the Eurasian Economic Commission dated August 19, 2014
No. 132”;
Decision of the Board of the Eurasian Economic Commission
dated June 9, 2015 No. 63 “On the Methodology for Analysis, Optimization,
Harmonization and Description of General Processes within the Eurasian
Economic Union”;
Decision of the Board of the Eurasian Economic Commission
dated September 28, 2015 No. 125 “On approval of the Regulations on the
exchange of electronic documents in the course of cross-border interaction of
public authorities of the Member States of the Eurasian Economic Union
with each other and with the Eurasian Economic Commission”.

II . Application area

2. This Procedure defines the requirements for the composition and

content of the procedures for putting into effect the general process
"Formation, maintenance and use of a unified register of registered medicines
of the Eurasian Economic Union" ( P . MM .01) (hereinafter referred to as the
general process) and joining a new participant to the general process, as well
as the requirements for the information interaction carried out during their
implementation.

III . Basic concepts

3. For the purposes of this Procedure, concepts are used that mean the
following:
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"documents used to ensure the functioning of the integrated system" -

technical, technological, methodological and organizational documents ,
provided for in paragraph 30 of the Protocol on information and
communication technologies and information exchange within the framework
of the Eurasian Economic Union (Appendix No. 3 to treaty on the Eurasian
Economic Union May 29, 2014);
« technological documents " - documents, included in typical scroll
technological documents, regulating information interaction in the
implementation of the overall process , provided for in paragraph 1 of the
Decision of the Board of the Eurasian Economic Commission dated
November 6, 2014 No. 200 .
Other concepts used in this Procedure are applied in the meanings
defined in paragraph om 4 Rules for Information Interaction in the
Implementation by Means of the Integrated Information System of Foreign
and Mutual Trade of the General Process " Formation, Maintenance and Use
of the Unified Register of Registered Medicinal Products of the Eurasian
Economic Union ", approved by the Decision of the Board of the Eurasian
Economic Commission от 25 октября 2016 г. № 122
(hereinafter referred to as the Rules for Information Interaction).

IV . Interaction participants

four. The roles of the participants in the interaction when they perform

the procedures provided for by this Procedure are given in Table 1.
Table 1
Roles of Interaction Participants
No. Role name Role Description Role Member
p/p

one Joining participant in performs the procedures authorized body of the

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No. Role name Role Description Role Member

p/p

the general process provided for by this Procedure Member State of the Union

2 Administrator coordinates the implementation Eurasian Economic

of the procedures provided for Commission
by this Procedure

3 Participant of the interacts in accordance with authorized body

general process technological documents and of the Member State of the
participates in testing Union,
information interaction with the Eurasian Economic
joining participant of the Commission
general process

V. _ Putting the overall process into action

5. From the date of entry into force of the Decision of the Board of the
Eurasian Economic Commission от 25 октября 2016 г. № 122
“ On technological documents regulating information interaction in the
implementation by means of an integrated information system of foreign and
mutual trade of the general process “Formation, maintenance and use of a
unified register of registered medicines of the Eurasian Economic Union” by
the Member States of the Union
(hereinafter referred to as the Member States) under the coordination of the
Eurasian Economic Commissions (hereinafter referred to as the Commission)
proceed to the implementation of the procedure for putting the general
process into effect.
6. To put the common process into operation, the
Member States must take the necessary measures determined by the
procedure for joining the common process in accordance with Section V I of
this Procedure.
7. Based on the recommendations of the commission for conducting
interstate tests of the integrated information system for foreign and mutual
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trade, the Board of the Commission adopts an order to put the general process
into effect.
8. The basis for the adoption of the recommendation of the commission
on conducting interstate tests of the integrated information system for foreign
and mutual trade the readiness of the overall process for implementation are
the results of testing the information interaction between the information
systems of all Member States and the Commission.

VI . Description of the connection procedure

9. Once a shared process is in place, new participants can join it by

performing the procedure for joining the shared process.
10. To join the general process by the joining participant of the general
process, the requirements of the documents used to ensure the functioning of
the integrated system, technological documents, as well as the requirements
of the legislation of the Member State governing information interaction
within the national segment of the Member State must be met.
11. The procedure for joining a new participant to the general process
includes:
a) informing by the member state of the Commission about the
accession of a new participant to the general process (indicating the
authorized body responsible for ensuring information exchange within the
framework of the general process);
b) making changes to the regulatory legal acts of the Member State
necessary to meet the requirements of technological documents (within 2
months from the date of commencement of the accession procedure);
in) development (improvement), if necessary, of the information
system of the joining participant in the general process, including in terms of
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the use of electronic digital signature (electronic signature) tools compatible

with the services of a trusted third party of the national segment of the
Member State (within
8 months from the date of commencement of the accession procedure );
G) connection of the information system of the joining participant of
the general process to the national segment
of the Member State, if such connection has not been made earlier (within 8
months from the date of commencement of the joining procedure);
e) receipt by the joining participant of the general process of directories
and classifiers distributed by the administrator, specified in the Rules for
Information Interaction;
e) testing of information interaction between the information systems of
the joining participants of the general process and participants of the general
process for compliance with the requirements of technological documents
(within 12 months from the date of commencement of the accession
procedure).

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