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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

(as amended of the Decision of Board of the Eurasian economic commission of 19.04.2022 No. 67)

According to Item 11 of the Protocol on information and communication technologies and information exchange within the Eurasian Economic Union (appendix No. 3 to the Agreement on the Eurasian Economic Union of May 29, 2014) and the Rules of registration and examination of medicines for medical application approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 78 (further – Rules of registration), the Board of the Eurasian economic commission solved:

1. Approve the enclosed Requirements to electronic type of statements and the documents of the registration file submitted when implementing registration and examination of medicines for medical application (further – Requirements).

2. Determine that development of technical schemes of structures of the documents in electronic form provided by Requirements and ensuring their placement in the register of structures of electronic documents and data published on the official site of the Eurasian Economic Union (further – the Union), 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 Union.

3. Determine that in case of realization in state members of the Union of electronic form of interaction in case of performing procedures according to Rules of registration the documents in electronic form provided by Requirements according to the technical schemes of structures of such documents containing in the register of structures of electronic documents and data are applied.

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

Chairman of Board of the Eurasian economic commission
T. Sargsyan

 

Approved by the Decision of Board of the Euroasian economic commission of June 30, 2017 No. 79

Requirements to electronic type of statements and the documents of the registration file submitted when implementing registration and examination of medicines for medical application

I. General provisions

1. These Requirements are developed for the purpose of creation of equal conditions for business entities of state members of the Eurasian Economic Union (further respectively - state members, the Union) on submission of data to authorized bodies of state members (the expert organizations) in the field of drug circulation when implementing registration and examination of medicines for medical application.

2. The concepts used in these Requirements are applied in the values determined by the Protocol on information and communication technologies and information exchange within the Eurasian Economic Union (appendix No. 3 to the Agreement on the Eurasian Economic Union of May 29, 2014), the Rules of registration and examination of medicines for medical application approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 78 (further - Rules of registration), and the technological documents regulating information exchange in case of realization by means of the integrated information system of foreign and mutual trade of general process "Forming, maintaining and use of the unified register of the registered medicines of the Eurasian Economic Union", approved by the Decision of Board of the Eurasian economic commission of October 25, 2016 No. 122.

3. These Requirements determine structure and rules of filling of the documents in electronic form submitted by the applicant to authorized bodies of the state members in case of performing procedures provided by Rules of registration.

4. Structure of the document in electronic form "Data on the statement for medicine registration" (R. 017) it is intended for electronic submission of the following types of statements:

a) the statement for medicine registration (reduction of the registration file of medicine in compliance with requirements of the Union) represented according to the Section I of appendix No. 2 to Rules of registration (further - the statement for registration);

b) the application for medicine re-registration submitted according to the Section II of appendix No. 2 to Rules of registration (further - the statement for registration confirmation);

c) the application for modification of the registration file of medicine submitted according to the Section III of appendix No. 2 to Rules of registration (further - the statement for modification).

5. Structure of the document in electronic form "Data of registration case or registration file of medicine" (R. 022) it is intended for electronic submission of documents of registration case or the registration file of medicine according to appendices No. 4 and 5 to Rules of registration.

6. The list of the documents submitted by the applicant in electronic form is determined by Rules of registration.

7. Specified in items 4 and 5 these Requirements documents in electronic form are created in XML format according to the Extensible Markup Language (XML) 1.0 (Fifth Edition) standard (it is published on the Internet to the address: http://www.w3.org/TR/REC-xml).

8. The coding (the standard of coding of symbols) shall be surely specified in preamble (prolog) of the XML document, any codings provided by the W3C standard are admissible.

9. Specified in items 4 and 5 these Requirements of structure of documents in electronic form represent set of the details located in hierarchical type.

10. The description of structures of documents in electronic form and the rule of their filling is provided in tabular form with indication of complete rekvizitny structure taking into account hierarchy levels up to simple (atomic) details (table 1 - 16 and 19).

11. For specifying of obligation of filling of details the following designations in the column "Plurality" ("Mn".) in tables 1 are used - 16 and 19:

0 - the detail is not filled;

1 - the detail is obligatory;

0. 1 - props are optional, repeatings are not allowed;

0.* - the props are optional, can repeat without restrictions;

1.* - the detail is obligatory, can repeat without restrictions.

12. In the column "Name of Detail" are specified the name of detail, and also in brackets the name of the element of data corresponding to it in the technical scheme of structure of the document in electronic form with indication of namespace prefix.

13. Technical schemes of structures of documents in electronic form "Data of registration case or registration file of medicine" (R. 022) and "Data on the statement for medicine registration" (R. 017) are conducted by the Eurasian economic commission (further - the Commission) in electronic form and take place in the register of structures of electronic documents and data published on the official site of the Union.

II. Requirements to structure of the document in electronic form "Data on the statement for medicine registration" (R. 017)

14. Structure of details of structure of the document in electronic form of "Data on statement for medicine registration" (R. 017) and general rules of their filling are provided in table 1.

15. Requirements to forming of XML documents according to structure of the document in electronic form "Data on the statement for medicine registration" (R. 017) are given in table 1.

Table 1

Structure of details of structure of the document in electronic form of "Data on statement for medicine registration" (R. 017)

Name of detail

Rule of filling of detail

Mn.

1. Code of the electronic document (data)

(csdo:EDocCode)

the specification symbol of the electronic document (data) according to the register of structures of electronic documents and data is specified

1

2. Identifier of the electronic document (data)

(csdo:EDocId)

the line of symbols which is unambiguously identifying the electronic document (data) is specified

1

3. Identifier of the initial electronic document (data)

(csdo:EDocRefId)

the identifier of the electronic document (data) in response to which this electronic document (data) was created is specified

0. 1

4. Date and time of the electronic document (data)

(csdo:EDocDateTime)

date and time of creation of the electronic document (data) are specified

1

5. Data on the statement for medicine registration

(hccdo:RegisteredDrugApplicationDetails)

general information about the statement for registration of medicine or other procedures connected with medicine registration is specified. The detail consists of values of the enclosed details 5.1 - 5.4

1

5.1. Number of the statement for medicine registration

(hcsdo:ApplicationId)

for the applications submitted to the states of recognition number of the statement assigned by authorized body of the reference state in the form of line no more than 50 symbols long without symbols of gap of line, carriage return and tabulation is specified

0. 1

5.2. Date of filing of application about medicine registration

(hcsdo:ApplicationReceiptDate)

date of filing of application about the registration of medicine or other procedures connected with medicine registration according to GOST ISO 8601-2001 is specified

1

5.3. Statement type code

(hcsdo:DrugApplicationKindV2Code)

the digital specification symbol of type of the submitted application according to the qualifier of document types of the registration file on medicine in the form of line 5 symbols long without symbols of gap of line, carriage return and tabulation is specified

1

a) identifier of the reference book (qualifier)

(codeListId attribute)

2058 value is specified

1

5.4. Code of type of the procedure of registration

(hcsdo:RegistrationKindCode)

the digital specification symbol of type of the procedure of registration according to the list of possible values is specified:

01 - procedure of mutual recognition;

02 - the decentralized procedure

1

5.5. Sign of registration of medicine on special procedure (with establishment of post-registration measures)

(hcsdo:DrugRegistrationSpecialProcedureIndicator)

the sign of registration of medicine on special procedure is specified (with establishment of post-registration measures):

1 - medicine is registered (is registered) on special procedure (with establishment of post-registration measures);

0 - medicine is registered (is registered) not on special procedure (with establishment of post-registration measures)

1

5.6. Code like special procedure of registration of medicine (with establishment of post-registration measures)

(hcsdo:DrugRegistrationSpecialProcedureCode)

the specification symbol like special procedure of registration of medicine (with establishment of post-registration measures) according to the list of possible values is specified:

1 - medicine registration in exceptional cases;

2 - conditional registration of medicine;

3 - the accelerated medicine examination;

4 - registration of medicine with establishment of additional requirements.

0. 1

The detail is filled if value of the detail "Sign of Registration of Medicine on Special Procedure (with Establishment of Post-registration Measures)" corresponds to value "1" - medicine is registered (is registered) on special procedure (with establishment of post-registration measures)

5.7. Sign of availability of special condition or post-registration measure as registration condition

(hcsdo:DrugRegistrationConditionIndicator)

the sign determining availability of special condition or post-registration measure as registration condition:

1 - the special condition or post-registration measure as condition of registration is present;

0 - the special condition or post-registration measure as condition of registration is absent

0. 1

5.8. Code of special condition or post-registration measure as registration condition

(hcsdo:DrugRegistrationConditionCode)

the specification symbol of special condition or post-registration measure as registration condition according to the list of possible values is specified:

1 - the medicine use restrictions set during medicine registration;

2 - the obligations of the holder of the registration certificate which are subject to accomplishment within registration;

3 - the terms of accomplishment of obligations and the imposed restrictions for the holder of the registration certificate established in case of medicine registration;

4 - status of accomplishment of obligations by the holder of the registration certificate. The detail is filled if value of the detail "Sign of Availability of Special Condition or Post-registration Measure as Registration Condition" corresponds to value "1" - the special condition or post-registration measure as condition of registration is present

0.*

6. Data on registration of medicine in state member of the Eurasian Economic Union

(hccdo:RegistrationCountryDetails)

data are specified for each state member to which the application, and also for each state member in which medicine is already registered is submitted. The detail consists of values of the enclosed details 6.1 - 6.7

0.*

6.1. Sign of registration of medicine in state member of the Eurasian Economic Union

(hcsdo:RegistrationCountryIndicator)

the sign is specified whether determining medicine in state member is registered:

1 - medicine is already registered in state member, the application is not submitted for its registration;

0 - medicine is not registered in state member, the application is submitted for its registration

1

6.2. Code of the reference state

(hcsdo:ReferenceUnifiedCountryCode)

the two-letter code of the reference state from the qualifier of the countries of the world according to ISO 3166-1 without symbols of gap of line, carriage return and tabulation is specified

0. 1

a) identifier of the reference book (qualifier)

(codeListId attribute)

P.CLS.019 value is specified

1

6.3. Code of the state of recognition

(hcsdo:RecognitionUnifiedCountryCode)

the two-letter code of the state of recognition from the qualifier of the countries of the world according to ISO 3166-1 without symbols of gap of line, carriage return and tabulation is specified

0. 1

a) identifier of the reference book (qualifier)

(codeListId attribute)

P.CLS.019 value is specified

1

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