Name of detail

Rule of filling of detail

Мн.

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) according to series of the ISO standards 8601 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 – 5.8

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 series of the ISO standards 8601 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.

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)

0. 1

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 restrictions of use of medicine 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 is submitted,
and also for each state member in which medicine is already registered. The detail consists of values of the enclosed details 6.1 – 6.9

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 according to the qualifier of the countries of the world without symbols of gap of line, carriage return and tabulation is specified

0. 1

a) identifier of the reference book (qualifier)
(codeListId attribute)

2021 value is specified

1

6.3. Code of the state of recognition
(hcsdo:RecognitionUnifiedCountryCode)

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

0. 1

a) identifier of the reference book (qualifier)
(codeListId attribute)

2021 value is specified

1

6.4. Country code
(csdo:UnifiedCountryCode)

the two-letter code of state member of the Eurasian Economic Union in which medicine, according to the qualifier of the countries of the world without symbols of gap of line, carriage return and tabulation is registered is specified

0. 1

a) identifier of the reference book (qualifier)
(codeListId attribute)

2021 value is specified

1

6.5. Code of other state
(hcsdo: OtherUnifiedCountryCode)

the two-letter code of other state member of the Eurasian Economic Union for filing of application according to the qualifier of the countries of the world without symbols of gap of line, carriage return and tabulation is specified

0.*

a) identifier of the reference book (qualifier)
(codeListId attribute)

2021 value is specified

1

6.6. Trade name of medicine
(hcsdo:DrugTradeName)

the trade name of medicine in state member in the form of line no more than 300 symbols long without symbols of gap of line, carriage return and tabulation is specified

1

6.7. Number of the regulating document on quality
(hcsdo:RegulatoryQualityDocId)

if medicine is already registered, number of the regulating document on quality of medicine in state member 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

6.8. Data on the issued registration certificate on medicine
(hccdo:IssuedRegistrationCertificateDetails)

data on the issued registration certificate are specified medicine. The detail consists of values of the enclosed details 6.8.1 – 6.8.4

0.*

6.8.1. Registration date of medicine
(hcsdo:DrugRegistrationDate)

registration date of medicine in state member (if medicine is already registered) according to series of the ISO standards 8601 is specified

0. 1

6.8.2. Sequence number of the registration certificate of medicine
(hcsdo:RegistrationNumberId)

if medicine is registered in the Union, the digital sequence number of the registration certificate of medicine in state member in the form of line 6 Arab figures long is specified

0. 1

6.8.3. Number of the national registration certificate
(hcsdo:NationalRegistrationCertificateId)

in case of filling of the statement for reduction of the registration file of medicine in compliance with requirements of the Union, number of the registration certificate of medicine from the national register of state member 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

6.8.4. Data on the copy of the registration certificate of medicine
(hccdo:DrugRegistrationCertificateCopyDetails)

data on the copy of the registration certificate are specified medicine. The structure of details and the rule of filling are brought in table 2

0. 1

6.9. Data on restriction of action of the registration certificate
(hccdo:RestrictionDetails)

data on refusals, responses and suspension of action of the registration certificate of medicine are specified. The detail consists of values of the enclosed details 6.9.1 – 6.9.5

0.*

6.9.1. Country code
(csdo:UnifiedCountryCode)

the two-letter country code according to the qualifier of the countries of the world without symbols of gap of line, carriage return and tabulation is specified

1