DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of October 25, 2016 No. 122

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 the registered medicines 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 unified register of the registered medicines 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 unified register of the registered medicines of the Eurasian Economic Union";

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 the registered medicines 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 unified register of the registered medicines of the Eurasian Economic Union";

Procedure for accession to general process "Forming, maintaining and use of the unified register of the registered medicines of the Eurasian Economic Union".

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 shall enter into force upon the expiry of 30 calendar days from the date of its official publication.

Approved by the Decision of Board of the Eurasian economic commission of October 25, 2016 No. 122

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 the registered medicines 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 agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014;

The decision of Council of the Eurasian economic commission of November 3, 2016 No. 78 "About Rules of registration and examination of medicines for medical application" (further – Rules of registration);

The decision of Council of the Eurasian economic commission of November 3, 2016 No. 84 "About procedures for forming and maintaining the unified register of the registered medicines of the Eurasian Economic Union and information databases in the field of drug circulation" (further – the Procedure for maintaining the unified register);

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".

The decision of Board of the Eurasian economic commission of June 30, 2017 No. 79 "About Requirements to electronic type of statements and the documents of the registration file submitted when implementing registration and examination of medicines for medical application".

II. Scope

2. These rules "Forming, maintaining and use of the unified register of the registered medicines 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:

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

"the general register" – the information resource containing the data on numbers, the statuses of processing of statements which are not subject to publication on holding the procedures connected with registration and examination of medicines, the information about structure of the documents processed during the specified procedures and also the data on registration certificates of the medicines included in the unified register of medicines of the Union which are subject to publication on information portal of the Union;

"registration case" – set of the documents created by authorized bodies of state members of the Union or on their request in the course of implementation of the procedures connected with registration and examination of medicine;

"data on medicine registration" – set of data on number and the status of processing of the statement on holding the procedures connected with registration and examination of medicine for structure of documents of registration case and the registration file of medicine, and also about the issued registration certificate of medicine.

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.

The concepts "state of recognition", "unified register of the registered medicines of the Union", "registration file", "registration certificate of medicine" and "reference state" used in these rules are applied in the values determined by the information reference book of concepts (terms) applied within the Union in the field of drug circulation, approved by the Eurasian economic commission.

IV. Main data on general process

5. Full name of general process: "Forming, maintaining and use of the unified register of the registered medicines of the Eurasian Economic Union".

6. Specification symbol of general process: P.MM.01, version 1.2.0.

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 (registered) medicines allowed for use.

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

a) create within the integrated information system of the Eurasian Economic Union (further – the integrated system) information resource, the general register containing data on the issued registration certificates of the registered medicines (further – the registration certificate);

b) provide possibility of receipt of state members of the Union by authorized bodies (further – authorized body of state member) to the up-to-date, complete and reliable information which is in the general register means of the integrated system;

c) provide possibility of obtaining by interested persons and staff of the Eurasian economic commission (further – the Commission) to the up-to-date, complete and reliable information containing in the unified register of the registered medicines of the Union (further – the unified register) with means of information portal of the Union;

d) provide use of state members of single system of normative reference information of the Union by authorized bodies (further – the EU to NSI).

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	the body of the Union providing access to data of the unified register on information portal of the Union and also submission of data on registration of medicines for requests of authorized bodies of state members means of the integrated system; receives data from authorized bodies of state members and updates the unified register and the general register; represents on requests of authorized bodies of state members of the data on registration of medicines through the integrated system; receives from authorized bodies of state members of the data (documents) from registration case or the registration file on demand within the procedures of settlement of disagreements in case of medicine registration
P.MM.01.ACT.001	authorized body of state member	the public authority of state member authorized on implementation of registration of medicines or the organization authorized by it which represents to the Commission of the data on the registered medicines and data on statements on holding the procedures connected with registration and examination of medicines for updating of the general register; receives from the Commission on request of the data on registration of medicines through the integrated system
P.MM.01.ACT.002	authorized body of the reference state	authorized body of state member which performs consideration of the submitted application, examination of registration case or the registration file, preparation and submission of data of the expert valuation report of safety, efficiency and quality for review, the direction of the notification on change of data on registration of medicine in authorized body of the state of recognition, submission of data of the statement on holding procedures of registration of medicine in authorized body of the state of recognition, and also storage and representation at the request of authorized bodies of the states of recognition and the Commission of data of registration files and registration cases of medicines
P.MM.01.ACT.003	authorized body of the state of recognition	the authorized body of state member which performs consideration of the application on holding the procedures connected with registration and examination of medicine receives the notification on change of data on medicine registration, creates and sends to authorized body of the reference state the notification on impossibility of consideration of the application on holding the procedures connected with registration and examination of medicine receives on demand documents of the registration file and registration case of medicine, carries out expertize of medicine with use of materials of registration case and (or) the registration file, performs consideration of the expert valuation report of safety, efficiency and quality, represents the decision on recognition (non-recognition) of the expert report or the note concerning the expert valuation report of safety, efficiency and quality
P.MM.01.ACT.004	the authorized body which cancelled the registration certificate	the authorized body of state member which made the decision on cancellation of registration of medicine in the territory of state member
P.MM.01.ACT.005	the authorized body notified on cancellation of the registration certificate	authorized body of state member which receives the notification on medicine registration cancellation by authorized body of other state member
P.MM.01.ACT.006	interested person	legal entity or physical person which requests data from the unified register on information portal of the Union. Can act as the interested person both subjects of drug circulation, and the interested public authorities

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 general register;

b) procedures of the direction of data on registration of medicine and consideration of data on the statement on holding procedures of registration of medicine;

c) procedures of receipt of the data containing in the general register;

d) procedures of receipt by the Commission of the data and documents containing in registration case or the registration file;

e) procedures of obtaining by authorized body of the state of recognition of the data and documents containing in registration case or the registration file;

e) procedures of the notification on cancellation of the registration certificate;

g) procedures of conducting correspondence concerning registration case or the registration file.

11. In case of performing procedures of general process forming of the general register based on the state members represented by authorized bodies in the Commission of data on the registered medicines, and also data on statements on holding the procedures connected with registration and examination of medicine, provided by Rules of registration (further – data on statements), submission of data on registration of medicines to authorized bodies of state members by means of the integrated system, and also provision of access to data of the unified register on information portal of the Union for interested persons is performed.

In case of accomplishment by authorized bodies of state members of procedures of registration, registration confirmation (re-registration), modification of the registration file or the procedures connected with registration of medicine, established by Rules of registration (further – procedures of registration), forming of the general register due to accomplishment of the following procedures of general process included in group of procedures of forming and maintaining the general register by them is performed:

inclusion of data in the general register;

change of the data containing in the general register;

exception of data of the general register;

the direction of data on the document which is subject to placement in the unified register;

direction of the conclusion about impossibility of recognition of the expert report.

Unique registration number of the statement is assigned by means of the integrated system and returns to authorized body of the reference state within accomplishment of the "Inclusion of Data in the General Register" procedure (P.MM.01.PRC.001). Unique registration number of the statement is assigned by means of the integrated system and returns to authorized body of the state of recognition within accomplishment of the "Inclusion of Data in the General Register" procedure (P.MM.01.PRC.001) only in case of modification of the registration file of the registered medicine without involvement of authorized body of the reference state in the cases provided by Rules of registration (Item 2.1.5 of Appendix No. 19 of Rules of registration in edition of the Decision of Council of the Commission of May 29, 2024 No. 43).

By consideration of state members of statements by authorized bodies on holding procedures of registration of medicine, and also in case of change of structure of documents of registration case or the registration file on medicine the following procedures of general process included in group of procedures of the direction of data on registration of medicine and consideration of data on the statement on holding procedures of registration of medicine are performed:

the direction of data on the statement on holding procedures of registration of medicine;

the notification on impossibility of consideration of the application on holding procedures of registration of medicine;

notification on change of data on medicine registration.

In case of submission of data on registration to authorized bodies of state members the following procedures of general process included in group of procedures of obtaining by authorized bodies of state members of the data containing in the general register are performed:

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

receipt of urgent data from the general register;

receipt of the changed data from the general register;

receipt of sequence number of the registration certificate;

receipt of data on registration of medicine from the general register;

receipt of data on the document placed in the unified register.

In case of need of receipt by the Commission of the data and documents containing in registration case or the registration file in case of settlement of disagreements on expert committee on medicines under the Commission (further – expert committee) the following procedures of general process included in group of procedures of obtaining by the Commission of the data containing in registration case or the registration file are performed:

receipt of data by the Commission from registration case or the registration file;

receipt of the document by the Commission from registration case or the registration file.

In case of need of obtaining by authorized body of the state of recognition of the data and documents containing in registration case or the registration file in case of medicine registration performing procedures, and also in other cases provided by Procedure for maintaining the unified register the following procedures of general process included in group of procedures of obtaining by authorized body of the state of recognition of the data containing in registration case or the registration file are performed:

receipt of data from registration case or the registration file;

receipt of the document from registration case or the registration file.

In case of decision making about cancellation of the registration certificate in the cases provided by Rules of registration the procedure of general process "The direction of the notification on cancellation of the registration certificate" is performed (P.MM.01.PRC.013) included in group of procedures of the notification on cancellation of the registration certificate.

Within consideration by authorized bodies of the states of recognition of the expert valuation report of safety, efficiency and the quality (further – the expert report) which is drawn up by authorized body of the reference state by results of medicine examination including, in case of decision making about recognition (non-recognition) of the expert report, and also in need of the direction of questions and (or) notes concerning documents of registration case or the registration file the following procedures of general process included in group of procedures of conducting correspondence concerning registration case or the registration file are performed:

direction of the expert report;

the direction of notes concerning documents of registration case or the registration file;

direction of the decision on recognition (non-recognition) of the expert report.

The documents of the registration file or registration case in the *.pdf format submitted by authorized bodies of state members in electronic form shall contain text layer.

The unique identifier of the document is UUID (universally unique identifier) calculated according to ISO/IEC 9834-8 according to version 5 (name-based version + SHA-1 hash) where as the identifier of namespace (name space identifier) "nil UUID" is used (00000000-0000-0000-0000-000000000000), and as name (name) the checksum determined by document file by algorithm SHA-1 is used.

The data transferred about the registration file shall contain information on all documents of all versions (sequences) of the electronic registration file, including shall contain the xml-documents received from the applicant.

The data transferred about the document of the registration file shall contain the details "Sequence of Provision of the File" and "Attribute of Transaction" known to the sender. By transfer of data on the document of registration case the detail "Sequence of Provision of the File" is specified according to the version of the file known to the sender according to which this document of registration case is constituted, and the detail "Attribute of Transaction" is not filled.

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 the procedures "Procedures of Forming and Maintaining the General Register" (P.MM.01.PGR.001)

15. Performing procedures of forming and maintaining the general register is performed when forming of state member of data by authorized body on the received application and the registration file, change of data on stage of consideration of the registration file of medicine, obtaining or change of documents of the registration file or registration case, and also in case of execution of the registration certificate.

In case of performing procedures of forming and maintaining the general register the authorized body of state member creates and represents to the Commission of the data according to Procedure for maintaining the unified register.

Submission of data is performed according to Regulations of information exchange between authorized bodies of state members 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 the registered medicines of the Eurasian Economic Union", the approved Decision of Board of the Eurasian economic commission of October 25, 2016 No. 122 (further – Regulations of information exchange between authorized bodies of state members 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 the registered medicines of the Eurasian Economic Union", to No. 122 approved by the Decision of Board of the Eurasian economic commission of October 25, 2016 (further – the Description of formats and structures of electronic documents and data).

In case of receipt of state members of the new statement by authorized bodies the "Inclusion of Data in the General Register" procedure is performed (P.MM.01.PRC.001).

The authorized body of the reference state which is carrying out inclusion of data on the new statement in the general register in case of successful accomplishment of the procedure receives the response message with the unique registration number of the statement assigned by means of the integrated system which is told the applicant. The authorized body of the state of recognition which is carrying out inclusion of data on the new statement in the general register in case of successful accomplishment of the procedure receives the response message with the unique registration number of the statement assigned by means of the integrated system only in case of modification of the registration file of the registered medicine without involvement of authorized body of the reference state in the cases provided by Rules of registration (Item 2.1.5 of Appendix No. 19 of Rules of registration in edition of the Decision of Council of the Commission of May 29, 2024 No. 43).

During the course of performance procedures of registration in case of change of stage of consideration of the registration file of medicine, decision making about medicine registration, change of data on the registered medicine, and also in case of change of structure of documents of registration case or the registration file the "Change of the Data Containing in the General Register" procedure is performed (P.MM.01.PRC.002).

In the cases of the termination of consideration of the application provided by Rules of registration the "Exception of Data of the General Register" procedure is performed (P.MM.01.PRC.003).

In need of transfer to the unified register of data on the document which is subject to placement in the unified register including after accomplishment of the "Change of the Data Containing in the General Register" procedure (P.MM.01.PRC.002), and also in case of modification of one of the documents placed in the unified register is performed the "Direction of Data on the Document Which Is Subject to Placement in the Unified Register" procedure (P.MM.01.PRC.019).

In case of impossibility of recognition by authorized body of the state of recognition of the expert report which is drawn up by authorized body of the reference state the "Direction of the Conclusion about Impossibility of Recognition of the Expert Report" procedure is performed (P.MM.01.PRC.020).

16. The provided description of group of the procedures "Procedures of Forming and Maintaining the General Register" (it is provided to P.MM.01.PGR.001) in the figure 2.

 

Fig. 2. General scheme of group of the procedures "Procedures of Forming and Maintaining the General Register" (P.MM.01.PGR.001)

17. The list of the procedures of general process entering into group of the procedures "Procedures of Forming and Maintaining the General Register" (P.MM.01.PGR.001), is given in table 2.

Table 2

The list of the procedures of general process entering into group of the procedures "Procedures of Forming and Maintaining the General Register" (P.MM.01.PGR.001)

Specification symbol	Name	Description
P.MM.01.PRC.001	inclusion of data in the general register	the procedure is intended for forming and representation of state member by authorized body in the Commission of data on the new statement, the information about structure of documents of registration case or the registration file for inclusion in the general register, and also for forming of unique registration number of the statement
P.MM.01.PRC.002	change of the data containing in the general register	the procedure is intended for forming and representation of state member by authorized body in the Commission of the data including changed about the registered medicine for updating of data of the unified register, the changed data on the statement, the changed information about structure of documents of registration case or the registration file for updating of the general register
P.MM.01.PRC.003	exception of data of the general register	the procedure is intended for forming and representation of state member by authorized body in the Commission of subjects to exception of the general register of data on the statement
P.MM.01.PRC.019	the direction of data on the document which is subject to placement in the unified register	the procedure is intended for forming and representation of state member by authorized body in the Commission of data on the document which is subject to placement in the unified register
P.MM.01.PRC.020	direction of the conclusion about impossibility of recognition of the expert report	the procedure is intended for forming and representation of the state of recognition by authorized body in the Commission of the conclusion about impossibility of recognition of the expert report

5. Group of the procedures "Procedures of the Direction of Data on Registration of Medicine and Consideration of Data on the Statement on Holding Procedures of Registration of Medicine" (P.MM.01.PGR.002)

18. Procedures of the direction of data on registration of medicine and consideration of data on the statement on holding procedures of registration of medicine are carried out when implementing procedures of registration of medicine in the states of recognition.

Submission of data is performed according to Regulations of information exchange between authorized bodies of state members 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 the registered medicines of the Eurasian Economic Union", the approved Decision of Board of the Eurasian economic commission of October 25, 2016 No. 122 (further – Regulations of information exchange between authorized bodies of state members).

In case of receipt of the statement by authorized body of the reference state on holding procedures of registration of medicine, including in the states of recognition, the "Direction of Data on the Statement on Holding Procedures of Registration of Medicine" procedure is performed (P.MM.01.PRC.004).

In case of impossibility of consideration of the state of recognition of the statement by authorized body on holding procedures of registration of medicine by results of check of completeness and (or) correctness of the submitted documents, and also in case of identification of the violations connected with payment of collection (duty) the "Notification on Impossibility of Consideration of the Application on Holding Procedures of Registration of Medicine" procedure is performed (P.MM.01.PRC.005).

In case of non-presentation by the applicant of the requested documents at the scheduled time in case of the registration performing procedures, other cases provided by Rules of registration for the notification on it of authorized body of the state of recognition of the reference state by authorized body, and also in case of change of structure of documents of the registration file or registration case the "Notification on Change of Data on Medicine Registration" procedure is performed (P.MM.01.PRC.006).

19. The provided description of group of the procedures "Procedures of the Direction of Data on Registration of Medicine and Consideration of Data on the Statement on Holding Procedures of Registration of Medicine" (it is provided to P.MM.01.PGR.002) in the figure 3.  

Fig. 3. General scheme of group of the procedures "Procedures of the Direction of Data on Registration of Medicine and Consideration of Data on the Statement on Holding Procedures of Registration of Medicine" (P.MM.01.PGR.002)

20. The list of the procedures of general process entering into group of the procedures "Procedures of the Direction of Data on Registration of Medicine and Consideration of Data on the Statement on Holding Procedures of Registration of Medicine" (P.MM.01.PGR.002), is given in table 3.

Table 3

The list of the procedures of general process entering into group of the procedures "Procedures of the Direction of Data on Registration of Medicine and Consideration of Data on the Statement on Holding Procedures of Registration of Medicine" (P.MM.01.PGR.002)

Specification symbol	Name	Description
P.MM.01.PRC.004	the direction of data on the statement on holding procedures of registration of medicine	the procedure is intended for the direction by authorized body of the reference state to authorized body of the state of recognition of the statement on holding procedures of registration of medicine
P.MM.01.PRC.005	the notification on impossibility of consideration of the application on holding procedures of registration of medicine	the procedure is intended for the direction by authorized body of the state of recognition to authorized body of the reference state of the notification on impossibility of consideration of the application on holding procedures of registration of medicine
P.MM.01.PRC.006	notification on change of data on medicine registration	the procedure is intended for the direction by authorized body of the reference state to authorized body of the state of recognition of the notification on change of data on medicine registration

6. Group of the procedures "Procedures of Receipt of the Data Containing in the General Register" (P.MM.01.PGR.003)

21. Procedures of obtaining by authorized bodies of state members of the data containing in the general register are carried out in case of receipt of the corresponding request from information systems of authorized bodies of state members.

Within performing procedures of obtaining by authorized bodies of state members of the data containing in the general register the following types of the requests arriving from information systems of authorized bodies of state members are processed:

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

request of urgent data from the general register;

request of the changed data from the general register;

request of sequence number of the registration certificate;

request of data on medicine registration;

request of data on the document placed in the general register.

Information request about date and time of updating of the general register is carried out by authorized body of state member for the purpose of assessment of need of synchronization of the data on statements which are available in its information resource, and also data on the registered medicines with the data which are containing in the general register and stored in the Commission. When implementing request the "Receipt of Information on Date and Time of Updating of the General Register" procedure is performed (P.MM.01.PRC.007).

The request of data is carried out from the general register for the purpose of obtaining by authorized body of state member of urgent data on statements, the data containing in registration case or the registration file and also data on the registered medicines. Depending on request conditions urgent data from the general register are represented on all reference states or on the specific reference state. The request of data from the general register can be performed both for current date, and as of the date specified in request. When implementing request the "Receipt of Urgent Data from the General Register" procedure is performed (P.MM.01.PRC.008).

Information request about the changes entered in the general register is carried out for the purpose of obtaining by authorized body of state member of the changed data on statements, data containing in registration case or the registration file and also data on the registered medicines. In case of information request about the changes entered in the general register data which were added to the general register, and also data to which changes since the moment specified in request until accomplishment of this request were made are represented (or till the moment specified in request). Depending on request conditions the changed data from the general register are represented on all reference states or on the specific reference state. When implementing request the "Receipt of the Changed Data from the General Register" procedure is performed (P.MM.01.PRC.009).

In case of decision making about medicine registration by authorized body of the reference state the "Receipt of Sequence Number of the Registration Certificate" procedure is performed (P.MM.01.PRC.010). In case of receipt of unique sequence number of the registration certificate the authorized body of the reference state performs the "Change of the Data Containing in the General Register" procedure (P.MM.01.PRC.002) for the purpose of inclusion and publication of data on the registered medicine, including about unique number of the registration certificate, in the unified register. The authorized body of the reference state informs authorized body of the state of recognition on medicine registration (including transfers data on sequence number of the registration certificate) by accomplishment of the "Notification on Change of Data on Medicine Registration" procedure (P.MM.01.PRC.006). The authorized body of the state of recognition can receive data on sequence number of the registration certificate also by accomplishment of the "Receipt of the Changed Data from the General Register" procedure (P.MM.01.PRC.009) or "Receipt of urgent data from the general register" (P.MM.01.PRC.008).

For obtaining by authorized body of state member of data on registration of medicine according to specific number of the statement or sequence number of the registration certificate the "Receipt of Data on Registration of Medicine from the General Register" procedure is performed (P.MM.01.PRC.017).

For obtaining by authorized body of state member of data on the document of the registration file or registration case placed in the unified register the "Receipt of Data on the Document Placed in the Unified Register" procedure is performed (P.MM.01.PRC.018).

22. The provided description of group of the procedures "Procedures of Receipt of the Data Containing in the General Register" (P.MM.01.PGR.003), it is provided in the figure 4.

 

Fig. 4. General scheme of group of the procedures "Procedures of Receipt of the Data Containing in the General Register" (P.MM.01.PGR.003)

23. The list of the procedures of general process entering into group of the procedures "Procedures of Receipt of the Data Containing in the General Register" (P.MM.01.PGR.003), is given in table 4.

Table 4

The list of the procedures of general process entering into group of the procedures "Procedures of Receipt of the Data Containing in the General Register" (P.MM.01.PGR.003)

Specification symbol	Name	Description
P.MM.01.PRC.007	receipt of information on date and time of updating of the general register	the procedure is intended for submission by the Commission of information on date and time of updating of the general register on requests from information systems of authorized bodies of state members
P.MM.01.PRC.008	receipt of urgent data from the general register	the procedure is intended for submission of urgent data by the Commission from the general register on requests from information systems of authorized bodies of state members
P.MM.01.PRC.009	receipt of the changed data from the general register	the procedure is intended for representation by the Commission of the changed data from the general register on requests from information systems of authorized bodies of state members
P.MM.01.PRC.010	receipt of sequence number of the registration certificate	the procedure is intended for submission of the future unique issue of the registration certificate by the Commission at the request of information system of authorized body of the reference state
P.MM.01.PRC.017	receipt of data on registration of medicine from the general register	the procedure is intended for submission by the Commission of data on registration of medicine on requests from information systems of authorized bodies of state members
P.MM.01.PRC.018	receipt of data on the document placed in the unified register	the procedure is intended for submission by the Commission of data on the document placed in the unified register on requests from information systems of authorized bodies of state members

7. Group of the procedures "Procedures of Receipt by the Commission of the Data and Documents Containing in Registration Case or the Registration File" (P.MM.01.PGR.004)

24. Procedures of receipt by the Commission of the data and documents containing in registration case or the registration file are carried out by the Commission in case of settlement of disagreements on expert committee in the cases provided by Rules of registration.

In case of need receipts by the Commission of data and documents of registration case or the registration file in case of settlement of disagreements on expert committee the procedures "Receipt of Data by the Commission from Registration Case or the Registration File" are performed (P.MM.01.PRC.011) and "Receipt of the document by the Commission from registration case or the registration file" (P.MM.01.PRC.021).

25. The provided description of group of the procedures "Procedures of Receipt by the Commission of the Data and Documents Containing in Registration Case or the Registration File" (P.MM.01.PGR.004), it is provided in the figure 5.

 

Fig. 5. General scheme of group of the procedures "Procedures of Receipt by the Commission of the Data and Documents Containing in Registration Case or the Registration File" (P.MM.01.PGR.004)

26. The list of the procedures of general process entering into group of the procedures "Procedures of Receipt by the Commission of the Data and Documents Containing in Registration Case or the Registration File" (P.MM.01.PGR.004), is given in table 5.

Table 5

The list of the procedures of general process entering into group of the procedures "Procedures of Receipt by the Commission of the Data and Documents Containing in Registration Case or the Registration File" (P.MM.01.PGR.004)

 

Specification symbol	Name	Description
P.MM.01.PRC.011	receipt of data by the Commission from registration case or the registration file	the procedure is intended for submission of data by authorized body of the reference state from registration case or the registration file at the request of the Commission
P.MM.01.PRC.021	receipt of the document by the Commission from registration case or the registration file	the procedure is intended for submission of the document by authorized body of the reference state from registration case or the registration file at the request of the Commission

8. Group of the procedures "Procedures of Obtaining by Authorized Body of the State of Recognition of the Data and Documents Containing in Registration Case or the Registration File" (P.MM.01.PGR.005)

27. Procedures of obtaining by authorized body of the state of recognition of the data and documents containing in registration case or the registration file it is carried out in the cases provided by Procedure for maintaining the unified register.

In case of need of obtaining by authorized body of the state of recognition of data and documents of registration case or the registration file the procedures "Receipt of Data from Registration Case or the Registration File" are performed (P.MM.01.PRC.012) and "Receipt of the document from registration case or the registration file" (P.MM.01.PRC.022).

28. The provided description of group of the procedures "Procedures of Obtaining by Authorized Body of the State of Recognition of the Data and Documents Containing in Registration Case or the Registration File" (P.MM.01.PGR.005), it is provided in the figure 6.

 

Fig. 6. General scheme of group of the procedures "Procedures of Obtaining by Authorized Body of the State of Recognition of the Data and Documents Containing in Registration Case or the Registration File" (P.MM.01.PGR.005)

29. The list of the procedures of general process entering into group of the procedures "Procedures of Obtaining by Authorized Body of the State of Recognition of the Data and Documents Containing in Registration Case or the Registration File" (P.MM.01.PGR.005), is given in table 6.

Table 6

The list of the procedures of general process entering into group of the procedures "Procedures of Obtaining by Authorized Body of the State of Recognition of the Data and Documents Containing in Registration Case or the Registration File" (P.MM.01.PGR.005)

Specification symbol	Name	Description
P.MM.01.PRC.012	receipt of data from registration case or the registration file	the procedure is intended for submission of data by authorized body of the reference state from registration case or the registration file at the request of authorized body of the state of recognition
P.MM.01.PRC.022	receipt of the document from registration case or the registration file	the procedure is intended for submission of the document by authorized body of the reference state from registration case or the registration file at the request of authorized body of the state of recognition

9. Group of the procedures "Procedures of the Notification on Cancellation of the Registration Certificate" (P.MM.01.PGR.006)

30. The "Direction of the Notification on Cancellation of the Registration Certificate" procedure (P.MM.01.PRC.013) is carried out in case of acceptance by authorized body of state member of the decision on cancellation of the registration certificate in the cases provided by Rules of registration.

31. The provided description of group of the procedures "Procedures of the Notification on Cancellation of the Registration Certificate" (it is provided to P.MM.01.PGR.006) in the figure 7.

 

Fig. 7. General scheme of group of the procedures "Procedures of the Notification on Cancellation of the Registration Certificate" (P.MM.01.PGR.006)

32. The list of the procedures of general process entering into group of the procedures "Procedures of the Notification on Cancellation of the Registration Certificate" (P.MM.01.PGR.006), is given in table 7.

Table 7

The list of the procedures of general process entering into group of the procedures "Procedures of the Notification on Cancellation of the Registration Certificate" (P.MM.01.PGR.006)

Specification symbol	Name	Description
P.MM.01.PRC.013	direction of the notification on cancellation of the registration certificate	the procedure is intended for the direction of the notification on cancellation of the registration certificate by the authorized body which cancelled the registration certificate, to the authorized body notified on cancellation of the registration certificate

10. Group of the procedures "Procedures of Conducting Correspondence concerning Registration Case or the Registration File" (P.MM.01.PGR.007)

33. Procedures of conducting correspondence concerning registration case or the registration file are carried out after execution of the expert report on results of examination of medicine by authorized body of the reference state, in case of approval of the expert report by the states of recognition, and also when implementing correspondence between authorized body of the state of recognition and authorized body of the reference state in case of performing procedures of registration or during action of the registration certificate.

After completion of execution of the expert report by authorized body of the reference state the Direction of the Expert Report procedure is performed (P.MM.01.PRC.014).

In case of availability at authorized body of the state of recognition of notes concerning documents of registration case or the registration file, including, in need of sending an inquiry to the applicant, the "Direction of Notes concerning Documents of Registration Case or the Registration File" procedure is performed (P.MM.01.PRC.015).

In case of acceptance by authorized body of the state of recognition of the decision on recognition (non-recognition) of the expert report the "Direction of the Decision on Recognition (Non-recognition) of the Expert Report" procedure is performed (P.MM.01.PRC.016).

34. The provided description of group of the procedures "Procedures of Conducting Correspondence concerning Registration Case or the Registration File" (it is provided to P.MM.01.PGR.007) in the figure 8.

 

Fig. 8. General scheme of group of the procedures "Procedures of Conducting Correspondence concerning Registration Case or the Registration File" (P.MM.01.PGR.007)

35. The list of the procedures of general process entering into group of the procedures "Procedures of Conducting Correspondence concerning Registration Case or the Registration File" (P.MM.01.PGR.007), is given in table 8.

Table 8

The list of the procedures of general process entering into group of the procedures "Procedures of Conducting Correspondence concerning Registration Case or the Registration File" (P.MM.01.PGR.007)

Specification symbol	Name	Description
P.MM.01.PRC.014	direction of the expert report	the procedure is intended for the direction by authorized body of the reference state to authorized body of the state of recognition of data on the prepared expert report constituted by results of medicine examination
P.MM.01.PRC.015	the direction of notes concerning documents of registration case or the registration file	the procedure is intended for representation of the state of recognition by authorized body in authorized body of the reference state of data on the inquiries sent to the applicant about submission of additional data, and also for the direction of notes concerning documents of registration case or the registration file in case of registration performing procedures
P.MM.01.PRC.016	direction of the decision on recognition (non-recognition) of the expert report	the procedure is intended for representation of the state of recognition by authorized body in authorized body of the reference state of data of the decision on recognition (non-recognition) of the expert report

V. Information objects of general process

36. 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 9.

Table 9

List of information objects

Specification symbol	Name	Description
P.MM.01.BEN.001	general register	the information resource containing: the data on statements which are not subject to publication, the information about structure of documents of registration case and the registration file; the data on the registration certificates included in the unified register which are subject to publication on information portal of the Union
P.MM.01.BEN.002	statement	data of the statement on registration performing procedures
P.MM.01.BEN.003	expert report	data of the expert report which is drawn up by authorized body of the reference state, and also the conclusion about possibility of recognition (non-recognition) of the expert report which is drawn up by authorized body of the state of recognition
P.MM.01.BEN.004	or put data of the registration file	the data and documents containing in the registration file and registration case

VI. Responsibility of participants of general process

37. 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

38. The list of reference books and qualifiers of general process is provided in table 10.

Table 10

List of reference books and qualifiers of general process

Specification symbol	Name	Type	Description
P.CLS.001	qualifier of the countries of the world	classifier	contains list of names of the countries and codes corresponding to them (No. 378), qualifier code in the EU NSI "2021" is applied according to the Decision of the Commission of the Customs union of September 20, 2010
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), reference book code in the EU NSI "1041" is applied according to the Decision of Board of the Commission of December 6, 2022
P.CLS.024	qualifier of languages	classifier	contains list of names of languages and their codes according to ISO 639-1 (No. 152), qualifier code in the EU NSI "2055" is applied according to the Decision of Board of the Commission of September 10, 2019
P.CLS.038	reference book of international non-proprietary names of medicines	reference book	contains list of codes and international non-proprietary names of medicines (No. 71), reference book code in the EU NSI "1016" is applied according to the Decision of Board of the Commission of May 10, 2018
P.CLS.039	the qualifier of units of measure of dosage and concentration of active ingredients as a part of medicines	classifier	contains list of codes and names of the units of measure used in pharmacology for quantitative expression of dosage and concentration of active ingredients (No. 150), qualifier code in the EU NSI "2044" is applied according to the Decision of Board of the Commission of September 7, 2018
P.CLS.041	nomenclature of dosage forms	classifier	contains list of codes and names of dosage forms (No. 158), qualifier code in the EU NSI "2057" is applied according to the Decision of Board of the Commission of September 17, 2019
P.CLS.044	the qualifier of the completing means of packaging of medicines	classifier	contains list of codes and names of the completing means containing in secondary (consumer) package of medicine (No. 171), qualifier code in the EU NSI "2059" is applied according to the Decision of Board of the Commission of October 8, 2019
P.CLS.046	qualifier of medicinal vegetable raw materials	classifier	contains list of codes and names of medicinal vegetable raw materials (No. 59), qualifier code in the EU NSI "2047" is applied according to the Decision of Board of the Commission of April 16, 2019
P.CLS.048	reference book of types of addresses	reference book	contains list of codes and names of types of addresses
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	qualifier of forms of business	classifier	contains list of codes and names of forms of business (No. 54), qualifier code in the EU NSI "2049" is applied according to the Decision of Board of the Commission of April 2, 2019
P.CLS.055	reference book of formats of data	reference book	contains list of codes and names of formats of the data appropriated by Administration of address space the Internet
P.CLS.068	the reference book of methods of identification of business entities in case of their state registration in state members of the Eurasian Economic Union	reference book	contains list of codes and names of methods of identification of business entities in case of their state registration in state members (No. 34), reference book code in the EU NSI "1033" is applied according to the Decision of Board of the Commission of March 10, 2020
P.CLS.069	qualifier of types of primary packages of medicines	classifier	contains list of codes and names of types of primary packages of medicines (No. 5), qualifier code in the EU NSI "2045" is applied according to the Decision of Board of the Commission of January 15, 2019
P.CLS.099	qualifier of units of measure and account of the Eurasian Economic Union	classifier	contains list of codes, including according to the international and regional standards, names, symbols of units of measure and the account (No. 145), qualifier code in the EU NSI "2064" is applied according to the Decision of Board of the Commission of October 27, 2020
P.CLS.109	reference book of the grouping, commonly accepted and chemical names of medicines	reference book	contains list of codes of the grouping, commonly accepted and chemical names of medicines (No. 13) is applied according to Recommendations of Board of the Commission of April 23, 2019
P.CLS.110	the reference book of the excipients used in case of production of medicines	reference book	contains list of codes and names of the excipients used in case of production of medicines (No. 95), reference book code in the EU NSI "1019" is applied according to the Decision of Board of the Commission of June 11, 2019
P.CLS.111	the reference book of functional purposes of the excipients used in case of production of medicines	reference book	contains list of codes and names of functional purposes of the excipients which are part of medicines (No. 103), reference book code in the EU NSI "1020" is applied according to the Decision of Board of the Commission of June 18, 2019
P.CLS.112	reference book of names of homeopathic material	reference book	contains list of codes and names of homeopathic material
P.CLS.113	qualifier of types of secondary (consumer) packages of medicines	classifier	contains list of codes and names of types of secondary (consumer) packages of medicines (No. 6), qualifier code in the EU NSI "2046" is applied according to the Decision of Board of the Commission of January 15, 2019
P.CLS.138	list of types of units of expression of composition of medicines	reference book	contains list of codes and names of types of units of expression of composition of medicines
P.CLS.139	list of types of size of dosage (concentration) of medicines	reference book	contains list of codes and names of types of size of dosage (concentration) of medicines
P.MM.01.CLS.001	anatomo-therapeutic-chemical qualifier of medicines	classifier	contains list of codes and names of the active ingredients which are part of the medicines approved by the World Health Organization (No. 50), qualifier code in the EU NSI "2039" is applied according to the Decision of Board of the Commission of April 10, 2018
P.MM.01.CLS.002	qualifier of document types of the registration file of medicine	classifier	contains list of codes and names of document types of the registration file on medicine (No. 159), qualifier code in the EU NSI "2058" is applied according to the Decision of Board of the Commission of September 17, 2019
P.MM.01.CLS.003	qualifier of document types of registration case of medicine	classifier	contains list of codes and names of document types of registration case of medicine (No. 64), qualifier code in the EU NSI "2040" is applied according to the Decision of Board of the Commission of April 24, 2018
P.MM.01.CLS.004	list of stages (stages) of production of medicines	reference book	contains list of codes and names of types of production phases of medicines (No. 149), reference book code in the EU NSI "1018" is applied according to the Decision of Board of the Commission of September 7, 2018
P.MM.01.CLS.005	reference book of structural elements of the registration file of medicine	reference book	contains list of codes and names of structural elements of the registration file of medicine (No. 159), reference book code in the EU NSI "1030" is applied according to the Decision of Board of the Commission of September 17, 2019
P.MM.01.CLS.007	qualifier of types of changes of the registration file of medicine	classifier	contains list of codes and names of types of changes of the registration file of medicine (No. 65), qualifier code in the EU NSI "2041" is applied according to the Decision of Board of the Commission of April 24, 2018
P.MM.01.CLS.008	the reference book of stages of consideration of the application on medicine registration	reference book	contains list of codes and names of stages of consideration of the application on medicine registration
P.MM.01.CLS.009	the reference book of types of special procedure of registration of medicine (with establishment of post-registration measures)	reference book	contains list of codes and names of types of special procedure of registration of medicine (with establishment of post-registration measures)
P.MM.01.CLS.010	the list of special conditions and post-registration measures as registration condition	reference book	contains list of codes and names of special conditions and post-registration measures as registration condition
P.MM.01.CLS.011	reference book of the statuses of the registration certificate	reference book	contains list of codes and names of the statuses of the registration certificate
P.MM.01.CLS.012	reference book of types of special conditions of registration of medicine	reference book	contains list of codes and names of types of special conditions of registration of medicine
P.MM.01.CLS.013	the reference book of types of attributes of the transaction which is carried out over the document of the registration file	reference book	contains list of codes and names of types of attributes of the transaction which is carried out over the document of the registration file
P.MM.01.CLS.014	the reference book of roles of state member in case of medicine registration	reference book	contains list of codes and names of roles of state member in case of medicine registration
P.MM.01.CLS.015	reference book of types of prototypes of packaging of medicine	reference book	contains list of codes and names of types of prototypes of packaging of medicine
P.MM.01.CLS.016	reference book of types of procedures of registration	reference book	contains list of codes and names of types of procedures of registration
P.MM.01.CLS.017	reference book of degrees of izmelchennost of raw part of vegetable ingredient of medicine	reference book	contains list of codes and names of degrees of izmelchennost of raw part of vegetable ingredient of medicine
P.MM.01.CLS.019	the reference book of functions of ingredients as a part of medicine	reference book	contains list of codes and names of functions of ingredients as a part of medicine
P.MM.01.CLS.021	reference book of additional signs of medicine	reference book	contains list of codes and names of additional signs of medicine
P.MM.01.CLS.022	the reference book of types of the registered medicine	reference book	contains list of codes and names of types of the registered medicine
P.MM.01.CLS.023	reference book of the statuses of orphan medicine	reference book	contains list of codes and names of the statuses of orphan medicine
P.MM.01.CLS.024	reference book of types of elements of documents of registration case or registration file on medicine	reference book	contains list of codes and names of types of elements of documents of registration case or the registration file on medicine
P.MM.01.CLS.025	the list of the reasons of impossibility of consideration of the applications on holding the procedures connected with registration and examination of medicine	reference book	contains list of codes and names of the reasons of impossibility of consideration of the applications on holding the procedures connected with registration and examination of medicine
P.MM.01.CLS.026	the reference book of types of the statements on performing procedures connected with medicine registration	reference book	contains list of codes and names of types of the statements on performing procedures connected with medicine registration

VIII. Procedures of general process

1. Procedures of forming and maintaining the general register

"Inclusion of Data in the General Register" procedure (P.MM.01.PRC.001)

39. The scheme of accomplishment of the "Inclusion of Data in the General Register" procedure (P.MM.01.PRC.001) is provided in the figure 9.

 

Fig. 9. Scheme of accomplishment of the "Inclusion of Data in the General Register" procedure (P.MM.01.PRC.001)

40. The "Inclusion of Data in the General Register" procedure (P.MM.01.PRC.001) is carried out in case of representation by authorized body of state member of data on the new statement for forming of the general register.

41. The first carries out transaction "Submission of data for inclusion in the general register" (P.MM.01.OPR.001) by results of which accomplishment of state member by authorized body are created and represented to the Commission of the data on the new statement included in the general register with indication of type of the statement, date of filing of application, the state of filing of application. In case of submission of data on the new statement the authorized body of the reference state does not specify registration number of the statement. In case of submission of data on the new statement the authorized body of the state of recognition does not specify number of the statement only in case of modification of the registration file of the registered medicine without involvement of authorized body of the reference state in the cases provided by Rules of registration (Item 2.1.5 of Appendix No. 19 of Rules of registration in edition of the Decision of Council of the Commission of May 29, 2024 No. 43)

42. In case of receipt in the Commission of data on the statement included in the general register transaction "Acceptance and processing of data on the statement included in the general register" is carried out (P.MM.01.OPR.002) by results of which accomplishment data on the statement join in the general register.

In case of receipt by the Commission of data on the new statement from authorized body of the reference state unique registration number of the statement which the Commission adds to data on the statement and keeps in the general register is created. The message containing data on the unique registration number assigned to the statement is transferred to authorized body of the reference state.

In case of receipt by the Commission of data on the new statement from authorized body of the state of recognition unique registration number of the statement is created and transferred to authorized body of the state of recognition only in case of modification of the registration file of the registered medicine without involvement of authorized body of the reference state in the cases provided by Rules of registration (Item 2.1.5 of Appendix No. 19 of Rules of registration in edition of the Decision of Council of the Commission of May 29, 2024 No. 43). In case of receipt by the Commission of data on the new statement from authorized body of the state of recognition in other cases to it the notification on results of processing of the received data goes.

43. In case of receipt in authorized body of state member of the message containing data on the unique registration number assigned to the statement or notifications on results of processing of the received data transaction "Receipt of the message containing data on the unique registration number assigned to the statement or notifications on results of processing of the received data" is carried out (P.MM.01.OPR.003) by results of which accomplishment acceptance and processing of the message containing data on the unique registration number assigned to the statement or notifications on results of processing of the received data are performed.

44. Result of accomplishment of the "Inclusion of Data in the General Register" procedure (P.MM.01.PRC.001) is inclusion of data on the statement in the general register, obtaining by authorized body of the message containing the unique registration number assigned to the statement or obtaining by authorized body of the state of recognition of the notification on results of processing of the received data.

45. The list of the transactions of general process which are carried out within the "Inclusion of Data in the General Register" procedure (P.MM.01.PRC.001), is given in table 11.

Table 11

The list of the transactions of general process which are carried out within the "Inclusion of Data in the General Register" procedure (P.MM.01.PRC.001)

Specification symbol	Name	Description
P.MM.01.OPR.001	submission of data for inclusion in the general register	it is provided in table 12 of these rules
P.MM.01.OPR.002	acceptance and processing of data on the statement included in the general register	it is provided in table 13 of these rules
P.MM.01.OPR.003	receipt of the message containing data on the unique registration number assigned to the statement or notifications on results of processing of the received data	it is provided in table 14 of these rules

Table 12

Activity description "Submission of Data for Inclusion in the General Register" (P.MM.01.OPR.001)

№ of payment order	Designation of element	Description
1	Specification symbol	P.MM.01.OPR.001
2	Name of transaction	submission of data for inclusion in the general register
3	Contractor	authorized body of state member
4	Accomplishment conditions	it is carried out in case of representation by authorized body of state member of data on the statement for forming of the general register
5	Restrictions	the format and structure of the represented data shall match the Description of formats and structures of electronic documents and data
6	Activity description	the contractor creates the message containing the data on the statement included in the general register intended for transfer to the Commission according to Regulations of information exchange between authorized bodies of state members and the Commission
7	Results	data on the statement for inclusion in the general register are transferred to the Commission

Table 13

Activity description "Acceptance and Processing of Data on the Statement Included in the General Register" (P.MM.01.OPR.002)

№ of payment order	Designation of element	Description
1	Specification symbol	P.MM.01.OPR.002
2	Name of transaction	acceptance and processing of data on the statement included in the general register
3	Contractor	Commission
4	Accomplishment conditions	it is carried out in case of receipt by the Commission of data on the statement (transaction "Submission of data for inclusion in the general register" (P.MM.01.OPR.001))
5	Restrictions	the format and structure of the represented data shall match the Description of formats and structures of electronic documents and data. Authorization is required, data are represented only by authorized bodies of state members. Details of the electronic document (data) shall conform to the requirements provided by Regulations of information exchange between authorized bodies of state members and the Commission
6	Activity description	the contractor accepts data on the statement and checks them according to Regulations of information exchange between authorized bodies of state members and the Commission. In case of successful accomplishment of check the contractor performs inclusion of data on the statement in the general register, filling up date and time of their updating. In case of primary inclusion of the statement by authorized body of the reference state the contractor creates and sends according to Regulations of information exchange between authorized bodies of state members and the Commission to authorized body of the reference state the message containing data on the unique registration number assigned to the statement. In case of primary inclusion of the statement by authorized body of the state of recognition the contractor creates and sends according to Regulations of information exchange between authorized bodies of state members and the Commission to authorized body of the state of recognition the message containing data on the unique registration number assigned to the statement only in case of modification of the registration file of the registered medicine without involvement of authorized body of the reference state in the cases provided by Rules of registration. In other cases of inclusion of the statement by authorized body of the state of recognition the contractor creates and sends according to Regulations of information exchange between authorized bodies of state members and the Commission to authorized body of the state of recognition the notification on results of processing of the received data

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