DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of March 10, 2026 No. 28

About modification of the Decision of Board of the Eurasian economic commission of May 30, 2023 No. 71

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. 71 "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 unified register of producers of veterinary medicines, which production to acknowledged relevant requirements of Rules of proper production practice 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. 28

The changes made to the Decision of Board of the Eurasian economic commission of May 30, 2023 No. 71

1. 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 unified register of producers of veterinary medicines which production acknowledged relevant requirements of Rules of proper production practice 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. 71

(in edition of the Decision of Board of the Eurasian economic commission of March 10, 2026 No. 28)

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 unified register of producers of veterinary medicines, which production to acknowledged relevant requirements of Rules of proper production practice 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 November 3, 2016 No. 77 "About approval of Rules of proper production practice of the Eurasian Economic Union";

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 Council of the Eurasian economic commission of September 23, 2022 No. 140 "About Regulations of the address of diagnostic means of veterinary appointment on customs area of the Eurasian Economic Union";

The decision of Council of the Eurasian economic commission of December 12, 2023 No. 150 "About Regulations of the address of disinfecting, disinsection and disacariasis means of veterinary appointment on customs area of the Eurasian Economic Union";

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 unified register of producers of veterinary medicines which production to acknowledged relevant requirements of Rules of proper production practice 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 unified register of producers of goods of veterinary appointment" – the general information resource containing data about the state members of the Eurasian Economic Union and the third countries which are in the territories producers of goods of veterinary appointment, production and which production sites following the results of pharmaceutical inspection are acknowledged conforming to requirements of Rules of proper production practice of the Eurasian Economic Union (further respectively – the register of producers, state member);

"national information resource" – the national information resource containing the information about producers of goods of veterinary appointment, production and which production sites conform to requirements of Rules of proper production practice of the Union;

"goods of veterinary appointment, TVN" – the object of general process determined as veterinary medicine, feed additive, and also the diagnostic, disinfecting, disinsection or disacariasis means of veterinary appointment which is not coming into direct contact with animals.

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 unified register of producers of veterinary medicines, which production to acknowledged relevant requirements of Rules of proper production practice of the Eurasian Economic Union".

6. Specification symbol of general process: P.SS.15, version 2.0.0.

1. Purpose and tasks of general process

7. The purpose of general process is ensuring single accounting of producers of goods of veterinary appointment which production to acknowledged relevant requirements of Rules of proper production practice of the Union (further respectively – the producer, Rules of proper practice) and provision to interested persons of data from the register of producers.

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

a) provide creation, forming and maintaining in the Eurasian economic commission (further – the Commission) the complete and urgent register of producers based on the data received from authorized bodies of state members (further – authorized bodies);

b) provide provision to authorized bodies at the request of data from the register of producers;

c) provide the mutual notification of authorized bodies on issue (change of the status) of the certificate of confirmation of conformity to producers of goods of veterinary appointment, whose production following the results of the carried-out pharmaceutical inspection conforms to requirements of Rules of proper practice (further – the certificate);

d) provide to interested persons possibility of receipt of the up-to-date and reliable information containing in the register of producers, means of information portal of the Union.

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 register of producers, provision of data from the register of producers on demand, and also the publication of information about producers on information portal of the Union
P.SS.15.ACT.001	authorized body	authorized body which performs submission to the Commission of data for forming and maintaining the register of producers; obtaining at the request of data from the register of producers; submission to the notified authorized body of data on issue (change of the status) of the certificate
P.SS.15.ACT.002	the notified authorized body	authorized body of state member which performs maintaining national information resource; receives the notification from authorized body of state member on issue (change of the status) of the certificate
P.SS.15.ACT.003	interested person	physical person or legal entity, and also the representatives of public authorities using in the activities data from the register of producers 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 register of producers;

b) procedures of receipt of data from the register of producers at the request of authorized bodies;

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 the information about producers of goods of veterinary appointment and perform submission to the Commission of information about producers of goods of veterinary appointment for forming of the register of producers, and also inform each other on issue (change of the status) of the certificate to the producer of goods of veterinary appointment which conform to requirements of Rules of proper practice. The commission on the basis of the received data from authorized bodies performs forming and maintaining the register of producers and publication of urgent information about producers of goods of veterinary appointment on information portal of the Union, and also provides on requests of authorized bodies the information about producers of goods of veterinary appointment from the register of producers. When forming the register of producers the following procedures of general process included in group of procedures of forming and maintaining the register of producers are performed:

inclusion of data in the register of producers;

change of data in the register of producers.

By provision of data on requests of authorized bodies the following procedures of general process included in group of procedures of receipt of data of the register of producers at the request of authorized bodies are performed:

receipt of information on date and time of updating of the register of producers;

receipt of data from the register of producers;

receipt of the changed data from the register of producers.

Under advice authorized bodies the following procedure of general process included in group of procedures of the notification of authorized bodies is performed:

notification of authorized body on issue (change of the status) of the certificate.

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 register of producers

15. Performing procedures of forming and maintaining the register of producers begins with the moment of acceptance by authorized body of state member of the decision on issue of the certificate to the producer of goods of veterinary appointment or about the termination or suspension of action of the certificate following the results of pharmaceutical inspection.

In case of performing procedures of forming and maintaining the register of producers the authorized body creates and represents to the Commission of the information about producers of goods of veterinary appointment for inclusion or change of data in the register of producers. 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 unified register of producers of veterinary medicines which production to acknowledged relevant requirements of Rules of proper production practice of the Eurasian Economic Union", the approved Decision of Board of the Eurasian economic commission of May 30, 2023 No. 71 (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 unified register of producers of veterinary medicines, which production to acknowledged relevant requirements of Rules of proper production practice of the Union", to No. 71 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).

In case of submission by authorized body to the Commission of information about the producer of goods of veterinary appointment for inclusion in the register of producers the "Inclusion of Data in the Register of Producers" procedure is performed (P.SS.15.PRC.001).

In case of submission by authorized body to the Commission of information about the producer of goods of veterinary appointment for modification of the register of producers the "Change of Data in the Register of Producers" procedure is performed (P.SS.15.PRC.002).

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

 

Fig. 2. General scheme of group of procedures of forming and maintaining register of producers

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

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

Specification symbol	Name	Description
P.SS.15.PRC.001	inclusion of data in the register of producers	the procedure is intended for submission by authorized body to the Commission of information about the producer of goods of veterinary appointment, for inclusion of data in the register of producers and their publication on information portal of the Union
P.SS.15.PRC.002	change of data in the register of producers	the procedure is intended for submission by authorized body to the Commission of the changed information about the producer of goods of veterinary appointment for updating of data in the register of producers and publications of updated data on information portal of the Union

5. Group of procedures of receipt of data of the register of producers at the request of authorized bodies

18. Procedures of receipt of data from the register of producers at the request of authorized bodies are performed in case of receipt of the corresponding request by the Commission from authorized bodies.

Submission of the specified data is performed according to 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 electronic documents and data.

Within performing procedures of receipt of data from the register of producers at the request of authorized bodies the following types of requests arriving from authorized bodies are processed:

information request about date and time of updating of the register of producers;

request of data from the register of producers;

request of the changed data from the register of producers.

Information request about date and time of updating of the register of producers is carried out by authorized body for the purpose of assessment of need of synchronization of the information about the producer which is stored at authorized body with the data which are containing in the register of producers, stored in the Commission.

When implementing request for provision of information on date and time of updating of the register of producers the "Receipt of Information on Date and Time of Updating of the Register of Producers" procedure is performed (P.SS.15.PRC.003).

The request of data is carried out from the register of producers for the purpose of receipt by authorized body of all information about the producers included in the register of producers. The data containing in the register of producers are requested or in full, or as of certain date and time. When implementing request of information about the producer the "Receipt of Data from the Register of Producers" procedure is performed (P.SS.15.PRC.004).

In case of request of the changed data from the register of producers the information which was added to the register of producers or to which changes since the moment specified in request until accomplishment of this request were made are provided. When implementing request of the changed data from the register of producers the "Receipt of the Changed Data from the Register of Producers" procedure is performed (P.SS.15.PRC.005).

19. The provided description of group of procedures of receipt of data of the register of producers at the request of authorized bodies is provided in the figure 3.

 

Fig. 3. The general scheme of group of procedures of receipt of data of the register of producers at the request of authorized bodies

20. The list of the procedures of general process entering into group of procedures of receipt of data of the register of producers at the request of authorized bodies 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 register of producers at the request of authorized bodies

Specification symbol	Name	Description
P.SS.15.PRC.003	receipt of information on date and time of updating of the register of producers	the procedure is intended for assessment by authorized body of need of synchronization of information about the producers who are stored at authorized body with the data containing in the register of producers
P.SS.15.PRC.004	receipt of data from the register of producers	the procedure is intended for receipt of data from the register of producers
P.SS.15.PRC.005	receipt of the changed data from the register of producers	the procedure is intended for synchronization of information about the producers who are stored at authorized body with the data containing in the register of producers

6. Group of procedures of the notification of authorized bodies

21. The procedure of the notification of authorized bodies on issue (change of the status) of the certificate is performed for the purpose of mutual informing authorized bodies on issue of the certificate to the producer of goods of veterinary appointment whose production conforms to requirements of Rules of proper practice, and inclusion of the specified producer in the register, and also about change of the status of the certificate.

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 unified register of producers of veterinary medicines which production to acknowledged relevant requirements of Rules of proper production practice of the Eurasian Economic Union", the approved Decision of Board of the Eurasian economic commission of May 30, 2023 No. 71 (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.

In case of submission by authorized body to the notified authorized body of data on issue (change of the status) of the certificate the "Notification of Authorized Body on Issue (Change of the Status) of the Certificate" procedure is performed (P.SS.15.PRC.006).

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.15.PRC.006	notification on issue (change of the status) of the certificate	the procedure is intended for the notification of authorized bodies on issue (change of the status) of the certificate

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.15.BEN.001	information about the producer	the information about the producer of goods of veterinary appointment from national information resource represented in case of interaction of authorized bodies and the Commission and also between authorized bodies

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