Decision of Board of the Eurasian economic commission "About modification of the Decision of Board of the Eurasian economic commission of October 25, 2016 No. 122"

DECISION OF BOARD OF THE EURASIAN ECONOMIC COMMISSION

of June 29, 2026 No. 77

About modification of the Decision of Board of the Eurasian economic commission of October 25, 2016 No. 122

According to Item 30 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) the Board of the Eurasian economic commission SOLVED:

1. Bring in the 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" of change according to appendix.

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

Chairman of Board of the Eurasian economic commission

B. Sagintayev

Appendix

to the Decision of Board of the Eurasian economic commission of June 29, 2026 No. 77

The changes made to the Decision of Board of the Eurasian economic commission of October 25, 2016 No. 122

1. In 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" approved by the specified Decision:

a) in table 11:

to exclude line items of P.MM.01.CLS.009 and P.MM.01.CLS.010;

add with line items of the following content:

"	P.MM.01.CLS.028	reference book of the reasons of suspension of action of the registration certificate	reference book	contains list of codes and names of the reasons of suspension of action of the registration certificate
	P.MM.01.CLS.029	reference book of conditions of cancellation of the registration certificate	reference book	contains list of codes and names of conditions of cancellation of the registration certificate	";

b) in punta 201, shall be replaced with words 202 words "about the new statement on holding procedures of registration of medicine for forming of the single database" "in the single database";

c) in table 100:

in the name of the word "about the new statement on holding procedures of registration of medicine for forming of the single database" shall be replaced with words "in the single database";

in P.MM.01.OPR.073 line item in the column second "received" to exclude the word;

d) in table 103 in the name and the column of the third line item "received" to exclude the 2nd word;

e) in the table 108 to replace specification symbol of "P.MM.01.OPR.088" with specification symbol of "P.MM.01.OPR.078";

e) in table 110 in the name and the column of the third line item shall be replaced with words 2 words "processing of data" "processing of data for exception".

2. In the 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" approved by the specified Decision:

a) in table 26:

in line item the second to state the 2nd column in the following edition: "value of the detail "Trade Name of Medicine" (hcsdo:DrugTradeName) as a part of the detail "Data on Registration of Medicine in State Member" (hccdo:DrugCountryRegistrationDetails) shall match with value of the detail "Trade Name of Medicine" (hcsdo:DrugTradeName) as a part of the detail "Data on Registration" (hccdo:CountryDrugRegistrationDetails), "Data on the consideration of the application" transferred in the message of general process (P.MM.01.MSG.033) in response to which the message of general process "Data on number of the statement is received (P.MM.01.MSG. 013), the containing value of the detail "Number of the Statement for Medicine Registration" (hcsdo:ApplicationId) matching with value of the detail "Number of the Statement for Medicine Registration" (hcsdo:ApplicationId), "Data on the sequence number of the registration certificate" received in the message of general process (P.MM.01.MSG.015) which contains the value of the detail "Sequence Number of the Registration Certificate of Medicine" (hcsdo:RegistrationNumberId) matching with value of the detail "Sequence Number of the Registration Certificate of Medicine" (hcsdo:RegistrationNumberId) in the data transferred to the Unified register";

add with line item of the following content:

if at least 2 copies of the detail "Medicine Expiration Date" (hcsdo:ShelfLifeDurationDetails) are filled, then the detail "Name of Dosage Form" (hcsdo:DosageFormName) as a part of the detail "Medicine Expiration Date" (hcsdo:ShelfLifeDurationDetails) shall be filled

b) in table 27 in line item "3-82":

in the column of the first figure "3-82" to replace with figures "3-87";

in the column of the second figure "3-85" to replace with figures "3-87", shall be replaced with words words of "table 20" "table 26";

c) add table 35 with line item of the following content:

to the value containing in the detail "Number of the Statement for Medicine Registration" (hcsdo:ApplicationId) there shall correspond only 1 unique value of the detail "Sequence Number of the Registration Certificate of Medicine" (hcsdo:RegistrationNumberId)

d) state table 46 in the following edition:

"Table 46 of the Requirement to filling of details of electronic documents (data) "Of data on consideration of the application and (or) the registration file" (R.HC.MM.01.006), transferred in the message "Data on Consideration of the Application" (P.MM.01.MSG.033)

Requirement code	Formulation of the requirement
1	the detail "Number of the Statement for Medicine Registration" (hcsdo:ApplicationId) shall be filled if the detail "Code of Stage of Consideration of the Application on Medicine Registration" (hcsdo:ApplicationStatusCode) does not contain 01-reception of an application value and country code of the authorized body which directed the message does not correspond to value of the detail "Country code" (csdo:UnifiedCountryCode) as a part of the same copy of the detail "Data on Registration" (hccdo:CountryDrugRegistrationDetails) in which value of the detail "State Member Role Code" (hcsdo:CountryKindCode), corresponds to 01-the reference state value
2	the detail "Number of the Statement for Medicine Registration" (hcsdo:ApplicationId) shall be filled if the detail "Code of Stage of Consideration of the Application on Medicine Registration" (hcsdo:ApplicationStatusCode) does not contain 01-reception of an application value, country code of the authorized body which directed the message does not correspond to value of the detail "Country code" (csdo:UnifiedCountryCode) as a part of the same copy of the detail "Data on Registration" (hccdo:CountryDrugRegistrationDetails) in which the detail "State Member Role Code" (hcsdo:CountryKindCode), corresponds to 02-the state of recognition value and value of the detail "Code of Document Type of the Registration File on Medicine" (hcsdo:DrugRegistrationDocCode) as a part of the difficult detail "Data on the Document of the Registration File (Case)" (hccdo:RegistrationDossierDocDetails) does not correspond to "01003-the statement for modification of the registration file of medicine" value
3	the detail "Number of the Statement for Medicine Registration" (hcsdo:ApplicationId) shall not be filled if the following condition is satisfied: The direction from authorized body of the reference state in the Commission of the first message on receipt of the new statement. The message goes for the purpose of receipt of number of the statement by authorized body of the reference state. In such situation the detail "Number of the Statement for Medicine Registration" (hcsdo:ApplicationId) is not filled, at the same time: a) the detail "Code of Stage of Consideration of the Application on Medicine Registration" (hcsdo:ApplicationStatusCode) shall correspond to 01-reception of an application value; b) the country code of the authorized body which directed the message shall correspond to the detail "Country code" (csdo:UnifiedCountryCode) as a part of the same copy of the detail "Data on Registration" (hccdo:CountryDrugRegistrationDetails) in which the detail "State Member Role Code" (hcsdo:CountryKindCode), corresponds to 01-the reference state value.
4	the detail "Number of the Statement for Medicine Registration" (hcsdo:ApplicationId) shall not be filled if the following condition is satisfied: The direction from authorized body of the state of recognition in the Commission of the first message on receipt of the new statement for modification of the registration file of the registered medicine by authorized body of the state of recognition 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 N 43). The message goes for the purpose of receipt of number of the statement by authorized body of the state of recognition. In such situation the detail "Number of the Statement for Medicine Registration" (hcsdo:ApplicationId) is not filled, at the same time: a) the detail "Code of Stage of Consideration of the Application on Medicine Registration" (hcsdo:ApplicationStatusCode) shall correspond to 01-reception of an application value; b) the country code of the authorized body which directed the message shall correspond to the detail "Country code" (csdo:UnifiedCountryCode) as a part of the same copy of the detail "Data on Registration" (hccdo:CountryDrugRegistrationDetails) in which the detail "State Member Role Code" (hcsdo:CountryKindCode), corresponds to 02-the state of recognition value; c) the detail "Code of Document Type of the Registration File on Medicine" (hcsdo:DrugRegistrationDocCode) as a part of the difficult detail "Data on the Document of the Registration File (Case)" (hccdo:RegistrationDossierDocDetails) shall correspond to "01003-the statement for modification of the registration file of medicine" value
5	1 copy of the detail "Data on Consideration of the Application and (or) Registration File" (hccdo:DrugApprovalApplicationDetails) shall be filled
6	value the detail "Country code" (csdo:UnifiedCountryCode) as a part of the difficult detail "Data on Consideration of the Application and (or) Registration File" (hccdo:DrugApprovalApplicationDetails) shall correspond to the value specified in the message heading wsa:ReplyTo
7	if the detail "Code of Document Type of the Registration File on Medicine" (hcsdo:DrugRegistrationDocCode) as a part of the difficult detail "Data on the Document of the Registration File (Case)" (hccdo:RegistrationDossierDocDetails) corresponds to "01002-the statement for registration of medicine for medical application (reduction of the registration file of medicine in compliance with requirements of the Eurasian Economic Union)" value, then the detail "Sequence Number of the Registration Certificate of Medicine" (hcsdo:RegistrationNumberId) is not filled
8	if the detail "Code of Document Type of the Registration File on Medicine" (hcsdo:DrugRegistrationDocCode) as a part of the difficult detail "Data on the Document of the Registration File (Case)" (hccdo:RegistrationDossierDocDetails) corresponds to "01003-the statement for modification of the registration file of medicine" value or "01004-the statement for medicine re-registration" value, then the detail "Sequence Number of the Registration Certificate of Medicine" (hcsdo:RegistrationNumberId) shall be filled and shall contain in urgent record of the unified register, at the same time the country code of the authorized body which directed the message shall correspond to code of state member of the authorized body which provided urgent record to the unified register
9	there shall be one or several copies of the detail "Data on Registration" (hccdo:CountryDrugRegistrationDetails) from which the first copy shall contain the detail "State Member Role Code" (hcsdo:CountryKindCode) corresponding to 01-the reference state value, and in other copies this detail shall correspond to 02-the state of recognition value
10	values of the details "Country code" (csdo:UnifiedCountryCode) cannot repeat among copies of the detail "Data on Registration" (hccdo:CountryDrugRegistrationDetails)
11	the detail "Country code" (csdo:UnifiedCountryCode) shall contain specification symbol of state member from the qualifier of the countries of the world specified in the Section VII of Rules of information exchange in each copy of the detail "Data on Registration" (hccdo:CountryDrugRegistrationDetails), and the "identifier of the reference book (qualifier)" attribute (codeListId attribute) shall contain 2021 value in its structure
12	in each copy of the detail "Data on Registration" (hccdo:CountryDrugRegistrationDetails) the detail "Trade Name of Medicine" (hcsdo:DrugTradeName) shall be filled
13	if the detail "Code of Type of the Procedure of Registration" (hcsdo:RegistrationKindCode) is filled, then it shall correspond to one of values: 01 – procedure of mutual recognition; 02 – the decentralized procedure; 03 – registration at the initiative of authorized body of state member
14	the detail "Data on Stage of Consideration of the Application on Medicine Registration" (hccdo:ApplicationStatusDetails) shall be filled and shall contain information on the current stage
15	the detail "Code of Stage of Consideration of the Application on Medicine Registration" (hcsdo:ApplicationStatusCode) shall correspond to one of the following values: 01 – reception of an application; 02 – examination of the file; 03 – approbation of methods of quality control; 04 – inspection of production; 05 – preparation of the expert report; 06 – approval of the expert report; 07 – refusal; 08 – response according to the address of the applicant; 99 – another
16	if the detail "Code of Stage of Consideration of the Application on Medicine Registration" (hcsdo:ApplicationStatusCode) corresponds to 99-another value, then the detail "The Name of Stage of Consideration of the Application on Medicine Registration" (hcsdo:ApplicationStatusName) is filled surely
17	as a part of the detail "Data on Stage of Consideration of the Application on Medicine Registration" (hccdo:ApplicationStatusDetails) the detail "Date" (csdo:EventDate) shall be filled
18	the detail "Reason Code of Impossibility of Consideration of the Application" (hcsdo:ApprovalImpossibilityReasonCode) is not filled in
19	there shall be exactly one copy of the detail "Data on the Document of the Registration File (Case)" (hccdo:RegistrationDossierDocDetails)
20	the detail "Document Belonging Sign to the Registration File" (hcsdo:RegistrationFileIndicator) shall be filled and shall correspond 1 of values: "0 – document of registration case"; "1 – document of the registration file"
21	if value of the detail "Document Belonging Sign to the Registration File" (hcsdo:RegistrationFileIndicator) corresponds to 1-the document of the registration file value, then the detail "Code of Document Type of the Registration File on Medicine" (hcsdo:DrugRegistrationDocCode) as a part of the difficult detail "Data on the Document of the Registration File (Case)" (hccdo:RegistrationDossierDocDetails) shall be filled and its value shall contain specification symbol of document type from the qualifier of document types of the registration file of the medicine specified in the Section VII of Rules of information exchange, and the "identifier of the reference book (qualifier)" attribute (codeListId attribute) as a part of this detail shall contain 2058 value.
22	one of copies of the detail "Data on the Document of the Registration File (Case)" (hccdo:RegistrationDossierDocDetails) shall contain the detail "Code of Document Type of the Registration File on Medicine" (hcsdo:DrugRegistrationDocCode) corresponding 1 of values: 01002 – the statement for registration of medicine for medical application (reduction of the registration file of medicine in compliance with requirements of the Eurasian Economic Union); 01003 – statement for modification of the registration file of medicine; 01004 – statement for medicine re-registration
23	if value of the detail "Code of Document Type of the Registration File on Medicine" (hcsdo:DrugRegistrationDocCode) corresponds to 99999-other document value, then the detail "Name of Document Type of the Registration File on Medicine" (hcsdo:DrugRegistrationDocName) is filled surely
24	if value of the detail "Document Belonging Sign to the Registration File" (hcsdo:RegistrationFileIndicator) corresponds to 0-the document of registration case value, then the detail "Code of Document Type of Registration Case on Medicine" (hcsdo:DrugRegistrationFileCode) shall be filled and its value shall contain specification symbol of document type from the qualifier of document types of registration case of the medicine specified in the Section VII of Rules of information exchange, and the "identifier of the reference book (qualifier)" attribute (codeListId attribute) as a part of this detail shall contain 2040 value
25	the detail "The Name of Document Type of Registration Case on Medicine" (hcsdo:DrugRegistrationFileName) is filled surely if value of the detail "Code of Document Type of Registration Case on Medicine" (hcsdo:DrugRegistrationFileCode) corresponds to one of the following values: 0199 – another; 0299 – another; 0399 – another; 0499 – another
26	the detail "The Document in Binary Format" (hcsdo:DocCopyBinaryText) is not filled
27	the detail "XML document" (ccdo:AnyDetails) is not filled
28	the detail "Date" (csdo:EventDate) is not filled
29	the detail "Data on the Name of Medicine (Means)" (hccdo:DrugNameDetails) is not filled
30	the detail "Data on Dosage Form" (hccdo:DosageFormDetails) is not filled
31	the detail "Information about the Producer" is not filled (hccdo:ManufacturingAuthorizationHolderDetails)
32	the detail "Information about the Holder (Applicant) of the Registration Certificate" is not filled (hccdo:RegistrationCertificateHolderDetails)
33	the detail "Technical Characteristics on Record of General Resource" (ccdo:ResourceItemStatusDetails) is not filled	";

e) state table 47 in the following edition:

"Table 47 of the Requirement to filling of details of electronic documents (data) "Of data on consideration of the application and (or) the registration file" (R.HC.MM.01.006), transferred in the message "Data for Inclusion in the Single Database" (P.MM.01.MSG.034)

Requirement code	Formulation of the requirement
1	in single base there shall be no record in which value of the detail "Number of the Statement for Medicine Registration" (hcsdo:ApplicationId) matches with transferred in the message
2	the country code, representing data for inclusion in the single database, shall match with country code, the got corresponding number of the statement for registration of medicine in the detail "Number of the Statement for Medicine Registration" (hcsdo:ApplicationId) from the Commission in the message of general process of "Data on number of the statement" (P.MM.01.MSG.013), in case of accomplishment of the procedure of general process "The direction of data on consideration of the application" (P.MM.01.PRC.023)
3	value of the detail "Country code" (csdo:UnifiedCountryCode) as a part of the difficult detail "Data on Consideration of the Application and (or) Registration File" (hccdo:DrugApprovalApplicationDetails) shall correspond to the value of the detail "Country code" (csdo:UnifiedCountryCode) containing in structure of one of copies of the detail "Data on Registration" (hccdo:CountryDrugRegistrationDetails)
4	if the detail "Country code" (csdo:UnifiedCountryCode) as a part of any difficult details is filled, then its value shall correspond to country code from the qualifier of the countries of the world specified in the Section VII of Rules of information exchange and the "identifier of the reference book (qualifier)" attribute (codeListId attribute) shall contain 2021 value in its structure
5	only 1 copy of the detail "Data on Consideration of the Application and (or) Registration File" (hccdo:DrugApprovalApplicationDetails) shall be filled
6	the detail "Number of the Statement for Medicine Registration" (hcsdo:ApplicationId) shall be filled
7	if the detail "Code of Document Type of the Registration File on Medicine" (hcsdo:DrugRegistrationDocCode) contains 1 of values: 01003 – statement for modification of the registration file of medicine; 01004 – statement for medicine re-registration, that the detail "Sequence Number of the Registration Certificate of Medicine" (hcsdo:RegistrationNumberId) shall be filled
8	the detail "Date" (csdo:EventDate) shall be filled
9	the detail "Code of Document Type of the Registration File on Medicine" (hcsdo:DrugRegistrationDocCode) shall be filled
10	the detail "Code of Document Type of the Registration File on Medicine" (hcsdo:DrugRegistrationDocCode) shall contain specification symbol of document type from the qualifier of document types of the registration file of the medicine specified in the Section VII of Rules of information exchange, and the "identifier of the reference book (qualifier)" attribute (codeListId attribute) as a part of this detail shall contain 2058 value. The document type shall correspond to "the application for the procedure of registration issued according to the appendix N 2 to Rules of registration" value and can accept the following values: 01002 – the statement for registration of medicine for medical application (reduction of the registration file of medicine in compliance with requirements of the Eurasian Economic Union); 01003 – statement for modification of the registration file of medicine; 01004 – statement for medicine re-registration
11	one or several copies of the detail "Data on Registration" (hccdo:CountryDrugRegistrationDetails) from which the first copy shall contain the detail "State Member Role Code" (hcsdo:CountryKindCode) corresponding to 01-the reference state value shall be filled, and in other copies this detail shall correspond to 02-the state of recognition value
12	values of the details "Country code" (csdo:UnifiedCountryCode) cannot repeat among copies of the detail "Data on Registration" (hccdo:CountryDrugRegistrationDetails)
13	in each copy of the detail "Data on Registration" (hccdo:CountryDrugRegistrationDetails) the detail "Country code" (csdo:UnifiedCountryCode) shall be filled
14	if value of the detail "State Member Role Code" (hcsdo:CountryKindCode) corresponds to 02-the state of recognition value, then details shall not be filled: "Data on the name of medicine (means)" (hccdo:DrugNameDetails); "Data on dosage form" (hccdo:DosageFormDetails); "Data on medicine release form" (hccdo:PackageFormDetails); "Data on the producer" (hccdo:ManufacturingAuthorizationHolderDetails)
15	in each copy of the detail "Data on Registration" (hccdo:CountryDrugRegistrationDetails) the detail "Trade Name of Medicine" (hcsdo:DrugTradeName) shall be filled
16	if the detail "Data on the Name of Medicine (Means)" (hccdo:DrugNameDetails) is filled, then in its structure the detail "Code of the Name of Active Pharmaceutical Substance" (hcsdo:DrugCode) or the detail "Name of Active Pharmaceutical Substance" (hcsdo:DrugName) shall be filled
17	if the detail "Code of the Name of Active Pharmaceutical Substance" (hcsdo:DrugCode) is filled, then its value shall correspond to code from the reference book of international non-proprietary names of medicines provided in the Section VII of Rules of information exchange and the "identifier of the reference book (qualifier)" attribute (codeListId attribute) shall contain 1016 value in its structure
18	if the detail "Data on Dosage Form" (hccdo:DosageFormDetails) is filled, then in its structure the detail "Code of Dosage Form" (hcsdo:DosageFormCode) or "The name of dosage form" (hcsdo:DosageFormName) shall be filled
19	if the detail "Data on Medicine Release Form" (hccdo:PackageFormDetails) is filled, then in its structure the detail "Code of Dosage Form" (hcsdo:DosageFormCode) or "The name of dosage form" (hcsdo:DosageFormName) shall be filled
20	if the detail "Code of Dosage Form" (hcsdo:DosageFormCode) is filled, then its value shall correspond to code from the nomenclature of dosage forms specified in the Section VII of Rules of information exchange, and the "identifier of the reference book (qualifier)" attribute (codeListId attribute) shall contain 2057 value in its structure
21	if the detail "Code of Degree of Izmelchennost of Raw Part of Vegetable Ingredient" (hcsdo:DegreeRefinementRawMaterialCode) is filled, then it shall correspond to one of values: 01 – integral; 02 – crushed; 03 – powder; 99 – another
22	if value of the detail "Code of Degree of Izmelchennost of Raw Part of Vegetable Ingredient" (hcsdo:DegreeRefinementRawMaterialCode) corresponds to 99-another value, then the detail "Name of Degree of Izmelchennost of Raw Part of Vegetable Ingredient of Medicine" (hcsdo:DegreeRefinementRawMaterialName) is filled surely
23	if the detail "Data on Medicine Dosing Unit" (hccdo:DrugDosageUnitDetails) is filled, then in its structure the detail "Code of Type of Unit of Expression of Composition of Medicine" (hcsdo:DrugDosageUnitKindCode) or the detail "Name of Type of Unit of Expression of Composition of Medicine" (hcsdo:DosageUnitKindName) shall be filled
24	if the detail "Code of Type of Unit of Expression of Composition of Medicine" (hcsdo:DrugDosageUnitKindCode) is filled, then its value shall correspond to one of the following values: 01 – the dosage is specified per unit of dosage form; 02 – the dosage is specified per unit of dosing; 03 – the dosage is specified per unit mass; 04 – the dosage is specified per unit of amount; 05 – the dosage is specified total quantity of medicine in primary package; 06 – the dosage is specified per unit of amount after dissolution; 07 – the dosage is specified per unit of amount before cultivation; 08 – the dosage is specified per unit of time; 09 – the dosage is specified per unit of dosage form, matching with dosing unit
25	if the "unit of measure code of dosage and concentration" attribute (SubstanceMeasureCode attribute) is not filled, then the "unit of measurement name of dosage and concentration" attribute (SubstanceMeasureName attribute) is filled surely
26	if the "unit of measure code of dosage and concentration" attribute (SubstanceMeasureCode attribute) is filled, then its value shall correspond to code from the qualifier of units of measure of dosage and concentration of active ingredients as a part of medicines specified in the Section VII of Rules of information exchange, and the "identifier of the reference book (qualifier)" attribute (codeListId attribute) shall contain 2044 value
27	if the detail "Code of Function of Ingredient as a part of Medicine" (hcsdo:DrugSubstanceRoleCode) is filled, then it shall correspond to one of values: 01 – active ingredient; 02 – excipient; 03 – reagent
28	if value of the detail "Code of Function of Ingredient as a part of Medicine" (hcsdo:DrugSubstanceRoleCode) or the detail "The Name of Function of Ingredient as a part of Medicine" (hcsdo:DrugSubstanceRoleName) corresponds to "active ingredient" value, then as a part of the difficult Detail "Data on the Ingredient Which Is Part of Medicine" (hccdo:DrugSubstanceDetails) the detail "Data on Active Pharmaceutical Substance as a part of Medicine" (hccdo:ActiveSubstanceDetails) shall be filled, and the details "Data on Excipient as a part of Medicine" (hccdo:AuxiliarySubstanceDetails) and "The name of reagent" are not filled (hcsdo:ReagentName)
29	if value of the detail "Code of Function of Ingredient as a part of Medicine" (hcsdo:DrugSubstanceRoleCode) or the detail "The Name of Function of Ingredient as a part of Medicine" (hcsdo:DrugSubstanceRoleName) corresponds to reagent value, then as a part of the difficult Detail "Data on the Ingredient Which Is Part of Medicine" (hccdo:DrugSubstanceDetails) the detail "Name of Reagent" (hcsdo:ReagentName) shall be filled, and the details "Data on Active Pharmaceutical Substance as a part of Medicine" (hccdo:ActiveSubstanceDetails) and "Data on excipient as a part of medicine" are not filled (hccdo:AuxiliarySubstanceDetails)

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