DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of May 30, 2023 No. 69

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 of the low-quality, counterfeited and (or) counterfeit veterinary medicines revealed within the state control and supervision in the field of the address of veterinary medicines in the territories of state members of the Eurasian Economic Union"

According to Item 30 of the Protocol on information and communication technologies and information exchange within the Eurasian Economic Union (appendix № 3 to the Agreement on the Eurasian Economic Union of May 29, 2014) and being guided by the Decision of Board of the Eurasian economic commission of November 6, 2014 №200, the Board of the Eurasian economic commission decided:

1. Approve enclosed:

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 of the low-quality, counterfeited and (or) counterfeit veterinary medicines revealed within the state control and supervision in the field of the address of veterinary medicines in the territories of state members of the Eurasian Economic Union";

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 of the low-quality, counterfeited and (or) counterfeit veterinary medicines revealed within the state control and supervision in the field of the address of veterinary medicines in the territories of state members of the Eurasian Economic Union";

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 of the low-quality, counterfeited and (or) counterfeit veterinary medicines revealed within the state control and supervision in the field of the address of veterinary medicines in the territories of state members of the Eurasian Economic Union";

Procedure for accession to general process "Forming, maintaining and use of the single information database of the low-quality, counterfeited and (or) counterfeit veterinary medicines revealed within the state control and supervision in the field of the address of veterinary medicines in the territories of state members of the Eurasian Economic Union".

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

Approved by the Decision of Board of the Eurasian economic commission of May 30, 2023 No. 69

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 of the low-quality, counterfeited and (or) counterfeit veterinary medicines revealed within the state control and supervision in the field of the address 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";

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 Eurasian 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 Eurasian 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 Eurasian economic commission of August 19, 2014 №132";

The decision of Board of the Eurasian 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 of high-quality and substandard veterinary medicines, and also the counterfeited and (or) counterfeit veterinary medicines revealed within the state control and supervision in the field of the address 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 of the low-quality counterfeited and (or) counterfeit goods of veterinary appointment revealed within the state control and supervision in the field of the goods circulation of veterinary appointment in the territories of state members of the Union (further – the single database)" – the general information resource including data on goods of veterinary appointment on which the authorized body makes the decision on retirement or suspension of the address on customs area of the Union in connection with their low quality, falsification and (or) counterfeit nature of their origin by results of selective control of quality being in circulation in the territories of state members of goods of veterinary appointment (further – data on goods of veterinary appointment);

"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) expert organization of state member subordinated to this body (further – authorized body), containing data on goods of veterinary appointment;

"goods of veterinary appointment, TVN" – the object of general process determined as veterinary medicine, feed additive, 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 No. 63.

IV. Main data on general process

5. Full name of general process: "Forming, maintaining and use of the single information database of high-quality and substandard veterinary medicines, and also the counterfeited and (or) counterfeit veterinary medicines revealed within the state control and supervision in the field of the address of veterinary medicines in the territories of state members of the Eurasian Economic Union".

6. Specification symbol of general process: P.SS.13, version 2.0.0.

1. Purposes and tasks of general process

7. The purposes of general process are:

creation of conditions on providing the address on customs area of the Union of high-quality, safe and effective goods of veterinary appointment;

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 quality requirements, safety and efficiency of goods of veterinary appointment in the territories of the state members and their observance, and also taking measures necessary for consumer protection from use of poor-quality, counterfeited and (or) counterfeit goods of veterinary appointment.

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

a) provide forming and maintaining the complete and urgent single database on the basis of information exchange between authorized bodies and the Eurasian economic commission (further – the Commission) under the organization and carrying out selective control of quality which are in circulation in the territories of state members of goods of veterinary appointment;

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 on the low-quality counterfeited and (or) counterfeit goods of veterinary appointment revealed within the state control and supervision in the field of the goods circulation of veterinary appointment in the territories of state members of the Union 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 updating of data of information portal of the Union and operational informing interested persons;

d) provide use by participants of general process of single qualifiers and reference books.

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
1	2	3
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.13.ACT.001	authorized body	authorized body of state member which performs: forming and maintaining national information resource; submission of data on goods of veterinary appointment to the Commission for forming of the single database; receipt of data from the single database on request
P.SS.13.ACT.002	interested person	physical person or legal entity, and also the representatives of public authorities of state members requesting and receiving data from the single database 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" procedures (P.SS.13.PGR.001);

b) "Procedures of Receipt of the Data Containing in the Single Database" procedures (P.SS.13.PGR.002).

11. In case of performing procedures of general process authorized bodies provide the information for forming and maintaining the single database containing data on goods of veterinary appointment and submission of the specified data to the Commission for the purpose of forming and maintaining the 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.

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

 

Fig. 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 the procedures "Procedures of Forming and Maintaining the Single Database" (P.SS.13.PGR.001)

15. Performing procedures of forming and maintaining the single database begins when obtaining by the Commission from authorized body of data on goods of veterinary appointment for updating of the single database.

In case of submission by authorized body to the Commission of data on goods of veterinary appointment for inclusion in the single database the "Inclusion of Data in the Single Database" procedure is performed (P.SS.13.PRC.001).

In case of submission by authorized body to the Commission of the changed data on goods of veterinary appointment for modification of the single database the "Change of the Data Containing in the Single Database" procedure is performed (P.SS.13.PRC.002).

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 of high-quality and substandard veterinary medicines, and also the counterfeited and (or) counterfeit veterinary medicines revealed within the state control and supervision in the field of the address of veterinary medicines in the territories of state members of the Eurasian Economic Union", the approved Decision of Board of the Eurasian economic commission of May 30, 2023 No. 69 (further – Regulations of information exchange).

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 of high-quality and substandard veterinary medicines, and also the counterfeited and (or) counterfeit veterinary medicines revealed within the state control and supervision in the field of the address of veterinary medicines in the territories of state members of the Eurasian Economic Union", to No. 69 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 the procedures "Procedures of Forming and Maintaining the Single Database" (it is provided to P.SS.13.PGR.001) in the figure 2.

Fig. 2. General scheme of group of the procedures "Procedures of Forming and Maintaining the Single Database" (P.SS.13.PGR.001)

17. The list of the procedures of general process entering into group of the procedures "Procedures of Forming and Maintaining the Single Database" (P.SS.13.PGR.001), is given in table 2.

The table 2 List of Procedures of General Process, the procedures "Procedures of Forming and Maintaining the Single Database" entering into group (P.SS.13.PGR.001)

Specification symbol	Name	Description
1	2	3
P.SS.13.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 goods of veterinary appointment for inclusion in the single database is performed
P.SS.13.PRC.002	change of the data containing in the single database	in the course of accomplishment of the procedure by authorized body submission to the Commission of data on goods of veterinary appointment for modification of the single database is performed

5. Group of the procedures "Procedures of Receipt of the Data Containing in the Single Database" (P.SS.13.PGR.002)

18. Procedures of submission of the data containing in the single database begin with the moment of obtaining by the Commission, the corresponding request from authorized body.

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

request of data on date and time of updating of the single database;

request of data from the single database;

request of the changed data from the single database.

The request of data on date and time of updating of the single database is carried out by authorized body for the purpose of assessment of need of synchronization of the data on goods of veterinary appointment which are stored in national information resource of authorized body with the data which are stored in the single database. When implementing of the specified request the "Receipt of Data on Date and Time of Updating of the Single Database" procedure is performed (P.SS.13.PRC.003).

The request of data is carried out from the single database for the purpose of receipt by authorized body of urgent data on all goods of veterinary appointment which are stored in the single database on all state members or on specific state member (state members) depending on request conditions. The data containing in the single database are requested or in full, or as of certain date and time. When implementing of the specified request the "Receipt of Data from the Single Database" procedure is performed (P.SS.13.PRC.004).

The request of the changed data is carried out from the single database for the purpose of obtaining by authorized body of the changed data on the goods of veterinary appointment which are stored in the single database. In case of accomplishment of request the changed data from the single database are represented, addition or change of which came for the period from the date and time specified in request until accomplishment of request. The changed data from the single database are represented on all state members or on specific state member (state members), depending on request conditions. When implementing request the "Receipt of the Changed Data from the Single Database" procedure is performed (P.SS.13.PRC.005).

Submission of the specified data is performed according to Regulations of information exchange. The format and structure of the specified data shall match the Description of formats and structures of electronic documents and data.

19. The provided description of group of the procedures "Procedures of Receipt of the Data Containing in the Single Database" (it is provided to P.SS.13.PGR.002) in the figure 3.

Fig. 3. General scheme of group of the procedures "Procedures of Receipt of the Data Containing in the Single Database" (P.SS.13.PGR.002)

20. The list of the procedures of general process entering into group of the procedures "Procedures of Receipt of the Data Containing in the Single Database" (P.SS.13.PGR.002), is given in table 3.

The table 3 List of Procedures of General Process, the procedures "Procedures of Receipt of the Data Containing in the Single Database" entering into group (P.SS.13.PGR.002)

Specification symbol	Name	Description
1	2	3
P.SS.13.PRC.003	receipt of data on date and time of updating of the single database	in the course of accomplishment of the procedure assessment of need of synchronization of data on the goods of veterinary appointment which are stored in national information resource of authorized body with the data containing in the single database is performed
P.SS.13.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 goods of veterinary appointment containing in the single database is performed
P.SS.13.PRC.005	receipt of the changed data from the single database	in the course of accomplishment of the procedure by authorized body synchronization of data on the goods of veterinary appointment which are stored in its national information resource with the data containing in the single database is performed

V. Information objects of general process

21. 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 4.

Table 4 List of Information Objects

Specification symbol	Name	Description
1	2	3
P.SS.13.BEN.001	data of the single database	the data on goods of veterinary appointment represented by authorized body for forming and maintaining the single database and requested by authorized body from the single database

VI. Responsibility of participants of general process

22. Attraction to disciplinary responsibility for non-compliance with the requirements aimed at providing timeliness and completeness of transfer of the data participating in information exchange of officials and staff of the Commission is performed according to the Agreement on the Eurasian Economic Union of May 29, 2014, other international treaties and acts constituting the right of the Union, and officials and the staff of public authorities of state members – according to the legislation of state members.

VII. Reference books and qualifiers of general process

23. The list of reference books and qualifiers of general process is provided in table 5.

Table 5 List of Reference Books and Qualifiers of General Process

Specification symbol	Name	Type	Description
1	2	3	4
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.038	reference book of international non-proprietary names of medicines	reference book	contains list of codes and names of active ingredients of veterinary medicines
P.CLS.041	nomenclature of dosage forms	qualifier	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	qualifier	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

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