DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of August 30, 2016 No. 93

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 process "Forming, maintaining and use of the unified register of the authorized organizations of the Eurasian Economic Union performing carrying out researches (testing) of medical products for the purpose of their registration

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 foreign and mutual trade of general process "Forming, maintaining and use of the unified register of the authorized organizations of the Eurasian Economic Union performing carrying out researches (testing) of medical products for the purpose of their registration";

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 foreign and mutual trade of general process "Forming, maintaining and use of the unified register of the authorized organizations of the Eurasian Economic Union performing carrying out researches (testing) of medical products for the purpose of their registration";

The description of formats and structures of the electronic documents and data used for realization by means of the integrated information system of foreign and mutual trade of general process "Forming, maintaining and use of the unified register of the authorized organizations of the Eurasian Economic Union performing carrying out researches (testing) of medical products for the purpose of their registration";

Procedure for accession to general process "Forming, maintaining and use of the unified register of the authorized organizations of the Eurasian Economic Union performing carrying out researches (testing) of medical products for the purpose of their registration".

2. Determine that development of technical schemes of structures of the electronic documents and data provided by the Description approved by this Decision, and ensuring their placement in the register of structures of the electronic documents and data used in case of realization of information exchange in the integrated information system of foreign and mutual trade are performed by department of the Eurasian economic commission which competence includes coordination of works on creation and development of the integrated information system of the Eurasian Economic Union.

3. 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 August 30, 2016 No. 93

Rules of information exchange in case of realization by means of the integrated information system of foreign and mutual trade of general process "Forming, maintaining and use of the unified register of the authorized organizations of the Eurasian Economic Union performing carrying out researches (testing) of medical products for the purpose of their registration"

I. General provisions

1. These rules are developed according to the following acts entering the right of the Eurasian Economic Union (further - the Union):

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

The agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014;

The decision of the Supreme Eurasian economic council of December 23, 2014 No. 109 "About implementation of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union";

The decision of Council of the Eurasian economic commission of February 12, 2016 No. 30 "About approval of the Procedure for forming and maintaining information system in the field of the address of medical products";

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";

II. Scope

2. These rules forming, maintaining and use of the unified register of the authorized organizations of the Eurasian Economic Union performing carrying out researches (testing) of medical products for the purpose of their registration" (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:

"authorization" - provision to the participant of general process of the rights to accomplishment of certain actions;

"unified register" - the unified register of the authorized organizations of the Union performing carrying out researches (testing) of medical products for the purpose of their registration which forming and maintaining is performed by the Eurasian economic commission;

"authorized organization" - organization, the organization or the company (including medical institution or the organization) performing carrying out researches (testing) of medical products for the purpose of their registration.

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 unified register of the authorized organizations of the Eurasian Economic Union performing carrying out researches (testing) of medical products for the purpose of their registration".

6. Specification symbol of general process: P.MM.07, version 1.0.1.

1. Purpose and tasks of general process

7. The purpose of general process is creation of the premises for cost reduction connected with exchange of information about the authorized organizations of the Union performing carrying out researches (testing) of medical products for the purpose of their registration due to creation of general information space in the field of the address of medical products.

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

a) create within the integrated information system of foreign and mutual trade (further - the integrated system) the information resource containing data on the authorized organizations performing carrying out researches (testing) of medical products for the purpose of their registration;

b) provide possibility of receipt of state members of the Union by authorized bodies (further state members) with means of the integrated system of data from the unified register in electronic form and in the automated mode;

c) provide possibility of obtaining by interested persons and staff of the Eurasian economic commission (further - the Commission) the urgent, complete and authentic data from the unified register by means of use of information portal of the Union;

d) provide use by authorized bodies of state members 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 provides forming and maintaining the unified register; provides access to the data containing in the unified register
P.MM.07.ACT.001	authorized body of state member	body of state member which represents to the Commission of the data for updating of the unified register and requests in the automated data mode from the unified register through the integrated system
P.MM.07.ACT.002	interested person	person requesting information from the unified register

 

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 unified register;

b) procedures of submission of data from the unified register.

11. Within performing procedures of general process authorized bodies of state members provide submission to the Commission of data on authorized organizations. The commission on the basis of the received data enters changes in the unified register and publishes it on information portal of the Union. Information exchange between authorized body of state member and the Commission is performed with use of integration platform of the integrated system. The information access, containing in the unified register, for interested persons is performed by means of use of information portal of the Union.

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 foreign and mutual trade of general process "Forming, maintaining and use of the unified register of the authorized organizations of the Eurasian Economic Union performing carrying out researches (testing) of medical products for the purpose of their registration", the approved Decision of Board of the Eurasian economic commission of August 30, 2016 No. 93 (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 foreign and mutual trade of general process "Forming, maintaining and use of the unified register of the authorized organizations of the Eurasian Economic Union performing carrying out researches (testing) of medical products for the purpose of their registration", to No. 93 approved by the Decision of Board of the Eurasian economic commission of August 30, 2016 (further – the Description of formats and structures of electronic documents and data).

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 procedures of forming and maintaining the unified register

15. Procedures of forming and maintaining the unified register are carried out in process of representation of state members of data by authorized bodies for inclusion in the unified register. The authorized body of state member creates and directs
in the Commission by means of use of the integrated system information on change of data on authorized organizations.

Depending on type of changes the following procedures of general process included in group of procedures of forming and maintaining the unified register are performed:

"Inclusion of data in the unified register" (P.MM.07.PRC.001);

"Change of the data containing in the unified register" (P.MM.07.PRC.002);

"Exception of data of the unified register" (P.MM.07.PRC.003).

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

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

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

Table 2

The list of the procedures of general process entering into group of procedures of forming and maintaining the unified register

Specification symbol	Name	Description
1	2	3
P.MM.07.PRC.001	inclusion of data in the unified register	it is intended for inclusion of data on authorized organization in the unified register. The procedure includes submission to the Commission of data on authorized organization, updating of the unified register and its publication on information portal of the Union
P.MM.07.PRC.002	change of the data containing in the unified register	it is intended for modification of the data containing in the unified register. The procedure includes in submission to the Commission of the changed data on authorized organization, updating of the unified register and its publication on information portal of the Union
P.MM.07.PRC.003	exception of data of the unified register	it is intended for exception of data on authorized organization of the unified register. The procedure includes in submission to the Commission of the data on authorized organization which are subject to exception of the unified register, updating of the unified register and its publication on information portal of the Union

 

5. Group of procedures of submission of data of the unified register

18. Procedures of submission of data from the unified register are performed in case of receipt of requests from information systems of authorized bodies of state members. At the same time the following types of requests can be performed:

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

request of data from the unified register;

request of the changed data from the unified register.

Information request about date and time of updating of the unified register is performed for the purpose of assessment of need of synchronization of the authorized bodies of state members of data on the authorized organizations included in the unified register which are stored in information systems with the data which are containing in the unified register and stored in the Commission.

The request of data from the unified register is performed for the purpose of receipt of state member of urgent data by authorized body on the authorized organizations of all state members or one of state members included in the unified register depending on request conditions. The request of data from the unified register can be performed on condition both for current date, and for the date specified in request.

The request of the changed data from the unified register is performed
for the purpose of obtaining by authorized body of state member of the changed data. In case of accomplishment of request the data from the unified register added or changed since the date and time specified in request until accomplishment of request are represented. Depending on conditions of request data on the authorized organizations of all state members or one of state members included in the unified register are represented. The specified request is used in case of initial loading of data in national information resource, for example, in case of initialization of general process, in case of connection of new state member, recovery of information after failure.

Depending on type of request one of the following procedures included in group of procedures of submission of data of the unified register is carried out:

"Receipt of information on date and time of updating of the unified register" (P.MM.07.PRC.004);

"Receipt of data from the unified register" (P.MM.07.PRC.005)

"Receipt of the changed data from the unified register" (P.MM.07.PRC.006).

The specified procedures can consistently be performed, or each procedure can separately be performed from others depending on the request purposes.

19. The provided description of group of procedures of submission of data of the unified register is provided in the figure 3.

 

Fig. 3. General scheme of group of procedures of submission of data of the unified register

20. The list of the procedures of general process entering into group of procedures of submission of data of the unified register is provided
in table 3.

Table 3

The list of the procedures of general process entering into group of procedures of submission of data of the unified register

Specification symbol	Name	Description
1	2	3
P.MM.07.PRC.004	receipt of information on date and time of updating of the unified register	it is intended for submission of information on date and time of updating of the unified register on requests from information systems of authorized bodies of state members by means of use of the integrated system
P.MM.07.PRC.005	receipt of data from the unified register	it is intended for representation urgent as of the specified date of data from the unified register on requests from information systems of authorized bodies of state members by means of use of the integrated system
P.MM.07.PRC.006	receipt of the changed data from the unified register	it is intended for submission of the changed data from the unified register on requests from information systems of authorized bodies of state members by means of use of the integrated system

 

V. Information objects of general process

21. The list of information objects, data on which or from which are transferred in process of interaction between participants of general process are provided in table 4.

Table 4

List of information objects

Specification symbol	Name	Description
1	2	3
P.MM.07.BEN.001	unified register	information resource which contains data on the authorized organizations performing carrying out researches (testing) of medical products for the purpose of their registration which forming and maintaining is performed by the Commission based on the data provided by authorized bodies of state members

 

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 it 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 authorized bodies 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.019	qualifier of the countries of the world	qualifier	contains list of names of the countries of the world and their codes according to ISO 3166-1
P.CLS.024	qualifier of languages	qualifier	No. 152 approved by the Decision of Board of the Eurasian economic commission of September 10, 2019 contains list of names of languages and their codes according to ISO 639-1,
P.CLS.054	qualifier of forms of business	qualifier	contains the list of codes and names of forms of business approved by the Decision of Board of the Eurasian economic commission of April 2, 2019 No. 54
P.CLS.068	reference book of methods of identification of business entities	reference book	contains list of identifiers and names of methods of identification of business entities
P.MM.07.CLS.001	the qualifier of the work types and services constituting medical activities	qualifier	contains the classified list of the work types and services constituting medical activities, No. 70 approved by the Decision of Board of the Eurasian economic commission of May 10, 2018	".

 

VIII. Procedures of general process

1. Procedures of forming and maintaining the unified register

"Inclusion of Data in the Unified Register" procedure (P.MM.07.PRC.001)

24. The scheme of accomplishment of the "Inclusion of Data in the Unified Register" procedure (P.MM.07.PRC.001) is provided in the figure 4.

Fig. 4. Scheme of accomplishment of the "Inclusion of Data in the Unified Register" procedure (P.MM.07.PRC.001)

25. The "Inclusion of Data in the Unified Register" procedure (P.MM.07.PRC.001) is carried out in case of certification of authorized organization for the purpose of representation by authorized body of state member of data on this authorized organization for inclusion in the unified register.

26. The first carries out transaction "Submission of data for inclusion in the unified register" (P.MM.07.OPR.001) by results of which accomplishment the authorized body of state member creates and sends to the Commission of the data for inclusion in the unified register.

27. In case of receipt in the Commission of data for inclusion
in the unified register transaction "Acceptance and processing of data for inclusion in the unified register" is carried out (P.MM.07.OPR.002) by results of which accomplishment the Commission receives the specified data, carries out their processing and sends the notification on results of processing of the provided data to authorized body of state member.

28. In case of receipt in authorized body of state member of the notification on results of processing of data transaction "Receipt of the notification on results of processing of data for inclusion in the unified register" is carried out (P.MM.07.OPR.003) by results of which accomplishment the authorized body of state member which directed data receives the notification on results of processing of data.

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