DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of March 10, 2026 No. 27

About modification of the Decision of Board of the Eurasian economic commission of May 30, 2023 No. 70

According to Item 30 of the Protocol on information and communication technologies and information exchange within the Eurasian Economic Union (appendix No. 3 to the Agreement on the Eurasian Economic Union of May 29, 2014) the Board of the Eurasian economic commission SOLVED:

1. Bring in the Decision of Board of the Eurasian economic commission of May 30, 2023 No. 70 "About the technological documents regulating information exchange in case of realization by means of the integrated information system of the Eurasian Economic Union of general process "Forming, maintaining and use of the single information database on the adverse reactions at animals revealed in case of use of veterinary medicines in the territories of state members of the Eurasian Economic Union" changes according to appendix.

2. This Decision becomes effective after 30 calendar days from the date of its official publication.

Appendix

to the Decision of Board of the Eurasian economic commission of March 10, 2026 No. 27

The changes made to the Decision of Board of the Eurasian economic commission of May 30, 2023 No. 70

1. Rules of information exchange in case of realization by means of the integrated information system of the Eurasian Economic Union of general process "The forming, maintaining and use of the single information database on the adverse reactions at animals revealed in case of use of veterinary medicines in the territories of state members of the Eurasian Economic Union", approved by the specified Decision to state in the following edition:

"Are approved by the Decision of Board of the Eurasian economic commission of May 30, 2023 No. 70

(in edition of the Decision of Board of the Eurasian economic commission of March 10, 2026 No. 27)

Rules of information exchange in case of realization by means of the integrated information system of the Eurasian Economic Union of general process "Forming, maintaining and use of the single information database on the adverse reactions at animals revealed in case of use of veterinary medicines in the territories of state members of the Eurasian Economic Union"

I. General provisions

1. These rules are developed according to the following international treaties and acts constituting the right of the Eurasian Economic Union (further – the Union):

The agreement on the Eurasian Economic Union of May 29, 2014;

The decision of Council of the Eurasian economic commission of January 21, 2022 No. 1 "About Regulations of the address of veterinary medicines on customs area of the Eurasian Economic Union" (in edition of the Decision of Council of the Eurasian economic commission of April 22, 2024 No. 36);

The decision of Board of the Euroasian economic commission of November 6, 2014 №200 "About the technological documents regulating information exchange in case of realization by means of the integrated information system of foreign and mutual trade of general processes";

The decision of Board of the Eurasian economic commission of January 27, 2015 №5 "About approval of Rules of electronic data exchange in the integrated information system of foreign and mutual trade";

The decision of Board of the Euroasian economic commission of April 14, 2015 № 29 "About the list of general processes within the Eurasian Economic Union and modification of the Decision of Board of the Euroasian economic commission of August 19, 2014 № 132";

The decision of Board of the Euroasian economic commission of June 9, 2015 №63 "About the Analysis technique, optimization, harmonizations and descriptions of general processes within the Eurasian Economic Union";

The decision of Board of the Eurasian economic commission of September 28, 2015 № 125 "About approval of the Regulations on exchange of electronic documents in case of cross-border interaction of public authorities of state members of the Eurasian Economic Union among themselves and with the Eurasian economic commission".

II. Scope

2. These rules forming, maintaining and use of the single information database on the adverse reactions at animals revealed in case of use of veterinary medicines in the territories of state members of the Eurasian Economic Union" (further – general process), including the description of the procedures performed within this general process are developed for the purpose of determination of procedure and conditions of information exchange between participants of general process ".

3. These rules are applied by participants of general process in case of control of procedure for performing procedures and transactions within general process, and also during the designing, development and completion of components of the information systems providing realization of general process.

III. Basic concepts

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

"the single information database about adverse reactions at animals" – the general information resource containing data on adverse reactions at animals including the side effects which are not provided by instructions for use of the goods of veterinary appointment revealed in the territories of state members based on data on the adverse reactions received from national information resource (further – the single database);

"the national information resource" – information resource which creates and conducts the body of state member of the Union authorized in the field of the goods circulation of veterinary appointment (further – state member) and (or) subordinated to this body expert organization of state member (further – authorized body), containing data on adverse reactions at animals, including the side effects which are not provided by instructions for use of the goods of veterinary appointment revealed in case of use of goods of veterinary appointment in the territories of state members (further respectively – data on adverse reactions, adverse reaction);

"goods of veterinary appointment, TVN" – the object of general process determined as veterinary medicine, feed additive.

The concepts "group of procedures of general process", "information object of general process", "contractor", "transaction of general process", "procedure of general process" and "participant of general process" used in these rules are applied in the values determined by the Analysis technique, optimizations, the harmonization and the description of general processes within the Eurasian Economic Union approved by the Decision of Board of the Eurasian economic commission of June 9, 2015 № 63.

IV. Main data on general process

5. Full name of general process: "Forming, maintaining and use of the single information database on the adverse reactions at animals revealed in case of use of veterinary medicines in the territories of state members of the Eurasian Economic Union".

6. Specification symbol of general process: P.SS.14, version 2.0.0.

1. Purpose and tasks of general process

7. The purpose of general process is creation of conditions on providing the address on customs area of the Union of high-quality, safe and effective goods of veterinary appointment, and also increase in efficiency of accomplishment of functions of authorized bodies in the field of control (supervision) of the goods circulation of veterinary appointment, due to ensuring unity of mandatory requirements to quality, safety and efficiency of goods of veterinary appointment in the territories of state members and their observance by collection, processing and information analysis about the adverse reactions and side effects revealed at animals in case of use of goods of veterinary appointment.

8. For goal achievement of general process it is necessary to solve the following problems:

a) provide creation, forming, maintaining in full, and also timely updating by the Eurasian economic commission (further – the Commission) the single database based on data on the adverse reactions received from national information resource;

b) provide authorized bodies at the request of data from the single database;

c) provide publication on information portal of the Union of urgent and authentic data from the single database for all interested persons with possibility of search and provision of data in the set parameters, viewing, unloading and preserving data in certain formats, registrations of subscription to updates of data of information portal of the Union and operational informing interested persons;

d) provide mutual operational informing (notification) authorized bodies on adverse reactions (further – the notification on identification of adverse reaction);

e) develop, harmonize and staticize the lists, qualifiers and reference books applied at the moment by authorized bodies and necessary for forming and maintaining national information resource, exchange of data on adverse reactions and also to develop their electronic forms.

2. Participants of general process

9. The list of participants of general process is provided in table 1.

Table 1 List of Participants of General Process

Specification symbol	Name	Description
P.ACT.001	Commission	body of the Union which performs: forming and maintaining the single database, and also publication of data from the single database on information portal of the Union; provision of data from the single database in authorized body on demand
P.SS.14.ACT.001	authorized body	authorized body which performs: forming and maintaining national information resource; submission of data on adverse reactions to the Commission for forming of the single database; receipt of data on adverse reactions from the single database on request; the direction of the notification on identification of adverse reaction in the notified authorized body
P.SS.14.ACT.002	the notified authorized body	authorized body which performs: receipt of the notification on identification of adverse reaction from authorized body
P.SS.14.ACT.003	interested person	physical persons or legal entities, and also the representatives of public authorities of state members interested in receipt of data from the single database which request also receive data on information portal of the Union

3. Structure of general process

10. General process represents set of the procedures grouped according to the destination:

a) procedures of forming and maintaining the single database;

b) procedures of receipt of data from the single database;

c) procedures of the notification of authorized bodies.

11. In case of performing procedures of general process authorized bodies provide forming and maintaining the national information resource containing data on adverse reactions, and submission of the specified data in the Commission for the purpose of forming and maintaining the complete and urgent single database, and also publication of data from the single database on information portal of the Union for interested persons. The commission provides provision of data from the single database to authorized bodies on demand.

Authorized bodies also perform the notification of authorized bodies of other state members on identification of adverse reaction.

12. The provided description of structure of general process is provided in the figure 1.

 

Pic. 1. Structure of general process

13. The procedure for performing procedures of general process, grouped according to the destination, including the disaggregated activity description, is given in the Section VIII of these rules.

14. For each group of procedures the general scheme showing bonds between procedures of general process and procedure for their accomplishment is provided. The general scheme of procedures is constructed with use of the graphical notation of UML (unified modeling language – Unified Modeling Language) and supplied with the text description.

4. Group of procedures of forming and maintaining the single database

15. Performing procedures of forming and maintaining the single database is performed on the facts of identification of adverse reactions to the territories of state member and inclusion or change of information about them in national information resource.

In case of identification of adverse reaction the "Inclusion of Data in the Single Database" procedure is performed (P.SS.14.PRC.001), during the course of performance which the authorized body creates and sends to the Commission of the data on adverse reaction.

In case of change of data on adverse reaction the "Change of Data in the Single Database" procedure is performed (P.SS.14.PRC.002), during the course of performance which the authorized body creates and sends the changed data on adverse reaction to the Commission.

Submission of the specified data is performed according to Regulations of information exchange between authorized bodies of state members of the Eurasian Economic Union and the Eurasian economic commission in case of realization by means of the integrated information system of the Eurasian Economic Union of general process "Forming, maintaining and use of the single information database on the adverse reactions at animals revealed in case of use of veterinary medicines in the territories of state members of the Eurasian Economic Union", approved by the Decision of Board of the Eurasian economic commission of May 30, 2023 No. 70 (further – Regulations of information exchange between authorized bodies and the Commission). The format and structure of the represented data shall match the Description of formats and structures of the electronic documents and data used for realization by means of the integrated information system of the Eurasian Economic Union of general process "Forming, maintaining and use of the single information database on the adverse reactions at animals revealed in case of use of veterinary medicines in the territories of state members of the Eurasian Economic Union", to No. 70 approved by the Decision of Board of the Eurasian economic commission of May 30, 2023 (further – the Description of formats and structures of electronic documents and data).

16. The provided description of group of procedures of forming and maintaining the single database is provided in the figure 2.

 

Fig. 2. General scheme of group of procedures of forming and maintaining the single database

17. The list of the procedures of general process entering into group of procedures of forming and maintaining the single database is provided in table 2.

The table 2 List of Procedures of General Process, the procedures of forming and maintaining the single database entering into group

Specification symbol	Name	Description
P.SS.14.PRC.001	inclusion of data in the single database	in the course of accomplishment of the procedure by authorized body submission to the Commission of data on adverse reaction for their inclusion in the single database and publications on information portal of the Union is performed
P.SS.14.PRC.002	change of data in the single database	in the course of accomplishment of the procedure by authorized body submission to the Commission of the changed data on adverse reaction for modification of the single database and publications of the changed data on information portal of the Union is performed

5. Group of procedures of receipt of data of the single database

18. Procedures of receipt of data from the single database are performed in case of receipt of the corresponding request by the Commission from authorized bodies.

Within performing procedures of receipt of data from the single database the following types of requests are processed:

information request about date and time of updating of the single database;

request of data from the single database;

request of changes of data from the single database.

Information request about date and time of updating of the single database is carried out for the purpose of assessment of need of synchronization of data on the adverse reactions which are stored in national information resource with the data containing in the single database. When implementing request for provision of information on date and time of updating of the single database the "Receipt of Information on Date and Time of Updating of the Single Database" procedure is performed (P.SS.14.PRC.003).

The request of data is carried out from the single database for the purpose of receipt by authorized body of all data on the adverse reactions containing in the single database. The data containing in the single database are requested or in full, or as of certain date and time. When implementing request of data from the single database the "Receipt of Data from the Single Database" procedure is performed (P.SS.14.PRC.004).

In case of request of changes of data from the single database the information which was added to the single database, or to which changes, since the moment specified in request until accomplishment of this request were made are provided. When implementing request of changes of data from the single database the "Receipt of Changes of Data from the Single Database" procedure is performed (P.SS.14.PRC.005).

Provision of the specified data is performed according to Regulations of information exchange between authorized bodies and the Commission. The format and structure of the provided information shall match the Description of formats and structures of electronic documents and data

19. The provided description of group of procedures of receipt of data of the single database is provided in the figure 3.

 

Fig. 3. General scheme of group of procedures of receipt of data of the single database

20. The list of the procedures of general process entering into group of procedures of receipt of data of the single database is provided in table 3.

The table 3 List of Procedures of General Process, the procedures of receipt of data entering into group of the single database

Specification symbol	Name	Description
P.SS.14.PRC.003	receipt of information on date and time of updating of the single database	in the course of accomplishment of the procedure by authorized body assessment of need of synchronization of data on the adverse reactions which are stored in national information resource with the data containing in the single database is performed
P.SS.14.PRC.004	receipt of data from the single database	in the course of accomplishment of the procedure by authorized body obtaining at the request of data on the adverse reactions containing in the single database is performed
P.SS.14.PRC.005	receipt of changes of data from the single database	in the course of accomplishment of the procedure by authorized body synchronization of data on the adverse reactions which are stored in national information resource with the data containing in the single database is performed

6. Group of procedures of the notification of authorized bodies

21. Accomplishment of the procedure of the notification of authorized bodies is performed on the facts of identification of adverse reactions to the territories of state member and inclusion or change of information about them in national information resource for the purpose of increase in efficiency of mutual informing authorized bodies on cases of identification of adverse reactions.

In case of identification of adverse reaction or change of information about her in national information resource the "Notification on Identification of Adverse Reaction" procedure is performed (P.SS.14.PRC.006), during the course of performance which the authorized body creates and sends to the notified authorized body of the data on adverse reaction.

Submission of the specified data is performed according to Regulations of information exchange between authorized bodies of state members of the Eurasian Economic Union in case of realization by means of the integrated information system of the Eurasian Economic Union of general process "Forming, maintaining and use of the single information database on the adverse reactions at animals revealed in case of use of veterinary medicines in the territories of state members of the Eurasian Economic Union", approved by the Decision of Board of the Eurasian economic commission of May 30, 2023 No. 70 (further – Regulations of information exchange between authorized bodies). The format and structure of the represented data shall match the Description of formats and structures of electronic documents and data.

22. The provided description of group of procedures of the notification of authorized bodies is provided in the figure 4.

 

Fig. 4. General scheme of group of procedures of the notification of authorized bodies

23. The list of the procedures of general process entering into group of procedures of the notification of authorized bodies is provided in table 4.

The table 4 List of Procedures of General Process, the procedures of the notification of authorized bodies entering into group

Specification symbol	Name	Description
P.SS.14.PRC.006	notification on identification of adverse reaction	in the course of accomplishment of the procedure by authorized body forming and the direction in the notified authorized body of the notification on identification of adverse reaction is performed

V. Information objects of general process

24. The list of information objects, data on which or from which are transferred in process of information exchange between participants of general process are provided in table 5.

Table 5 List of Information Objects

Specification symbol	Name	Description
P.SS.14.BEN.001	data on adverse reaction	the data on adverse reactions represented for forming and maintaining the single database, requested from the single database, and also transferred in case of notifications of authorized bodies

VI. Responsibility of participants of general process

25. Attraction to disciplinary responsibility for non-compliance with the requirements aimed at providing timeliness and completeness of transfer of data of the officials and the staff of the Commission participating in information exchange is performed according to the Agreement, other international treaties and acts constituting the right of the Union, and officials and the staff of authorized bodies – according to the legislation of state members.

VII. Reference books and qualifiers of general process

26. The list of reference books and qualifiers of general process is provided in table 6.

Table 6 List of Reference Books and Qualifiers of General Process

Specification symbol	Name	Type	Description
P.CLS.001	qualifier of the countries of the world	reference book	contains list of codes and names of the countries of the world according to ISO 3166-1
P.CLS.008	list of types of means (channels) of communication	reference book	contains list of codes and names of types of means (channels) of communication (No. 192) is applied according to the Decision of Board of the Commission of December 6, 2022
P.CLS.024	qualifier of languages	classifier	contains list of names of languages and their codes according to ISO 639-1 (No. 152) is applied according to the Decision of Board of the Eurasian economic commission of September 10, 2019
P.CLS.039	the qualifier of units of measure of dosage and concentration of active ingredients as a part of medicines	classifier	contains list of codes and names of units of measure of dosage and concentration of active ingredients as a part of medicines
P.CLS.041	nomenclature of dosage forms	classifier	contains list of codes and names of dosage forms (No. 158) is applied according to the Decision of Board of the Commission of September 17, 2019
P.CLS.048	list of types of the address	reference book	contains list of codes and names of types of the address
P.CLS.053	reference book of results of processing of electronic documents and data	reference book	contains list of codes and names of results of processing of electronic documents and data
P.CLS.054	the qualifier of forms of business of managing within the Eurasian Economic Union	classifier	contains list of codes and names of forms of business (No. 54) is applied according to the Decision of Board of the Eurasian economic commission of April 2, 2019
P.CLS.055	reference book of formats of data	reference book	contains list of codes and names of formats of the data appropriated by Administration of address space the Internet
P.CLS.068	the reference book of methods of identification of business entities in case of their state registration in state members of the Eurasian Economic Union	reference book	contains list of identifiers and names of methods of identification of business entities in case of their state registration (No. 34) is applied according to the Decision of Board of the Eurasian economic commission of March 10, 2020
P.CLS.069	qualifier of types of primary packages of medicines	classifier	contains list of codes and names of types of primary packages of medicines (No. 5) is applied according to the Decision of Board of the Commission of January 15, 2019

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