DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of August 30, 2016 No. 94

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 single information database of monitoring of safety, quality and efficiency of medical products"

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 single information database of monitoring of safety, quality and efficiency of medical products";

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 single information database of monitoring of safety, quality and efficiency of medical products";

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 single information database of monitoring of safety, quality and efficiency of medical products";

Procedure for accession to general process "Forming, maintaining and use of the single information database of monitoring of safety, quality and efficiency of medical products".

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. 94

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 single information database of monitoring of safety, quality and efficiency of medical products"

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";

The decision of Board of the Eurasian economic commission of September 28, 2015 No. 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";

The decision of Board of the Eurasian economic commission of December 22, 2015 No. 174 "About approval of Rules of carrying out monitoring of safety, quality and efficiency of medical products".

II. Scope

2. These rules "Forming, maintaining and use of the single information database of monitoring of safety, quality and efficiency of medical products" (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 certain participant of general process of the rights to accomplishment of certain actions;

"the single database" - the single information database of monitoring of safety, quality and efficiency of medical products which forming and maintaining in electronic form is performed by the Eurasian economic commission. 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.

The concept "address of medical products" used in these rules is applied in the value determined by article 2 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 of December 23, 2014.

IV. Main data on general process

5. Full name of general process: "Forming, maintaining and use of the single information database of monitoring of safety, quality and efficiency of medical products".

6. Specification symbol of general process: P.MM.08, version 1.0.0.

1. Purpose and tasks of general process

7. The purposes of general process are:

a) creation of the premises for cost reduction connected with exchange of information about results of monitoring of safety, quality and efficiency of medical products due to creation of general information space in the field of the address of medical products;

b) creation of conditions for prevention of the address in the territory of the Union of the medical products which are not conforming to safety requirements, quality and efficiency due to operational representation to participants of general process of up-to-date information about medical products by means of the integrated information system of foreign and mutual trade (further - the integrated system).

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

a) create within the integrated system the information resource containing data on results of monitoring of safety, quality and efficiency of medical products;

b) provide possibility of receipt of state members of the Union by authorized bodies (further - state member) by means of the integrated system of data from the single database 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 single database by means of use of information portal of the Union;

d) provide use of single qualifiers and reference books when forming and maintaining the single database.

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	the body of the Union which is responsible for forming and maintaining the single database, and also use of data from it
P.MM.08.ACT.001	authorized body of state member	authorized body of state member which represents to the Commission of the data for updating of the single database and requests data from the single database through the integrated system
P.MM.08.ACT.002	interested person	person receiving data from the single database by means of use of 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 submission of data from the single database.

11. In case of performing procedures of general process the authorized body of state member represents to the Commission of the data on results of monitoring of safety, quality and efficiency of medical products. The commission on the basis of the received data makes changes to the single database and publishes it on information portal of the Union. The authorized body of state member requests in the Commission urgent data from the single database.

On information portal of the Union are not subject to publication of the data on unfavorable events (incidents), corrective actions, results of investigation of unfavorable event (incident), post-registration clinical monitoring of safety of medical products.

Information exchange between authorized body of state member and the Commission is performed with use of the integrated system. Access for interested persons to information containing in the single database 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 single information database of monitoring of safety, quality and efficiency of medical products", the approved Decision of Board of the Eurasian economic commission of August 30, 2016 No. 94 (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 single information database of monitoring of safety, quality and efficiency of medical products", to No. 94 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 single database

      15. Procedures are performed in process of receipt in authorized body of state member of data on results of monitoring of safety, quality and efficiency of medical products. The authorized body of state member creates and sends the received data on results of monitoring of safety, quality and efficiency of medical products to the Commission. Depending on type of changes the following procedures included in group of procedures of forming and maintaining the single database are performed:

      "Inclusion of data in the single database" (P.MM.08.PRC.001);

      "Change of data in the single database" (P.MM.08.PRC.002).

      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.

Table 2

The list of the procedures of general process entering into group of procedures of forming and maintaining the single database

Specification symbol	Name	Description
1	2	3
P.MM.08.PRC.001	inclusion of data in the single database	it is intended for inclusion of data in the single database. The procedure includes submission of data by authorized body of state member to the Commission, acceptance and processing of data, publication of data on information portal of the Union, the direction of the notification on inclusion of data in the single database
P.MM.08.PRC.002	change of data in the single database	it is intended for change of data in the single database. The procedure includes submission of data to the Commission, acceptance and processing of data, publication of data on information portal of the Union, the direction of the notification on change of data in the single database

 

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

18. Procedures of submission of data from the single database 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 single database;

request of data from the single database;

request of the changed data from the single database.

Information request about date and time of updating of the single database is performed for the purpose of synchronization of the data which are stored in information systems of authorized bodies of state members with the data which are containing in the single database and stored in the Commission.

The request of data from the single database is performed for the purpose of receipt of state member of urgent data by authorized body from the single database on all state members or on specific state member depending on request conditions. The request of data from the single database can be performed both as of current date, and for the date specified in request.

The request of the changed data from the single database is performed for the purpose of obtaining by authorized body of state member of the changed data on results of monitoring of safety, quality and efficiency of medical products. In case of accomplishment of request the data from the single database added or changed since the date and time specified in request until accomplishment of request are represented. Depending on data request conditions from the single database are represented on all state members or on specific state member. The specified request is used in case of initial loading of data, 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 single database is carried out:

"Receipt of information on date and time of updating of the single database" (P.MM.08.PRC.003);

"Receipt of data from the single database" (P.MM.08.PRC.004);

"Receipt of the changed data from the single database" (P.MM.08.PRC.005).

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 single database is provided in the figure 3.

      

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

20. The list of the procedures of general process entering into group of procedures of submission of data of the single database 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 single database

Specification symbol	Name	Description
1	2	3
P.MM.08.PRC.003	receipt of information on date and time of updating of the single database	it is intended for submission of information on date and time of updating of the single database on requests from information systems of authorized bodies of state members through the integrated system
P.MM.08.PRC.004	receipt of data from the single database	it is intended for submission of data from the single database on requests from information systems of authorized bodies of state members through the integrated system
P.MM.08.PRC.005	receipt of the changed data from the single database	it is intended for submission of the changed data from the single database on requests from information systems of authorized bodies of state members through 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.08.BEN.001	single database	the single information resource containing data on results of monitoring of safety, quality and efficiency of medical products

 

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 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 codes and names of the countries of the world according to ISO 3166-1
P.CLS.024	qualifier of languages	qualifier	contains list of codes and names of languages according to ISO 639-1
P.CLS.048	qualifier of types of result of processing of electronic documents and data	qualifier	contains list of codes and names of types of result of processing of electronic documents and data
P.CLS.054	qualifier of forms of business	qualifier	contains list of codes and names of forms of business
P.CLS.064	nomenclature of medical products of the Eurasian Economic Union	reference book	contains list of types of medical products with indication of their nomenclature names, codes and descriptions of types of medical products
P.MM.08.CLS.001	qualifier of types of unfavorable events	qualifier	contains list of codes and names of types of unfavorable events
P.MM.08.CLS.002	the qualifier of types of users of medical products at the time of emergence of unfavorable events (incidents)	qualifier	contains list of codes and names of types of users of medical products at the time of emergence of unfavorable events (incidents)

 

VIII. Procedures of general process

1. Procedures of forming and maintaining the single database

"Inclusion of Data in the Single Database" procedure (P.MM.08.PRC.001)

24. The scheme of accomplishment of the "Inclusion of Data in the Single Database" procedure (P.MM.08.PRC.001) is provided in the figure 4.

      

Fig. 4. Scheme of accomplishment of the "Inclusion of Data in the Single Database" procedure (P.MM.08.PRC.001)

25. The "Inclusion of Data in the Single Database" procedure (P.MM.08.PRC.001) is carried out in case of receipt by authorized body of state member of data on results of monitoring of safety, quality and efficiency of medical products.

26. The first carries out transaction "Submission of data for inclusion in the single database" (P.MM.08.OPR.001) by results of which accomplishment the authorized body of state member creates and sends to the Commission of the data, safety received as a result of monitoring, quality and efficiency of medical products, for inclusion in the single database.

27. In case of receipt in the Commission of data for inclusion in the single database transaction "Acceptance and processing of data for inclusion in the single database" is carried out (P.MM.08.OPR.002) by results of which accomplishment the Commission receives the specified data.

28. In case of receipt in authorized body of state member of the notification on results of processing of data for inclusion in the single database transaction "Receipt of the notification on results of processing of data for inclusion in the single database" is carried out (P.MM.08.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.

29. In case of transaction accomplishment "Acceptance and processing of data for inclusion in the single database" (P.MM.08.OPR.002) is carried out transaction "Publication of the single database after inclusion of data" (P.MM.08.OPR.004) by results of which accomplishment on information portal of the Union the updated single database is published.

30. Result of accomplishment of the "Inclusion of Data in the Single Database" procedure (P.MM.08.PRC.001) is inclusion in the single database of the data received as a result of monitoring of safety, quality and efficiency of medical products and publication of the single database on information portal of the Union.

31. The list of the transactions of general process which are carried out within the "Inclusion of Data in the Single Database" procedure (P.MM.08.PRC.001), is given in table 6.

Table 6

The list of the transactions of general process which are carried out within the "Inclusion of Data in the Single Database" procedure (P.MM.08.PRC.001)

Specification symbol	Name		Description
1	2		3
P.MM.08.OPR.001	submission of data for inclusion in the single database		it is provided in table 7 of these rules
P.MM.08.OPR.002	acceptance and processing of data for inclusion in the single database		it is provided in table 8 of these rules

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info