Ennov InSight RIM Publisher 7.1

eCTD Attributes South Africa

You can use the following attributes to describe eCTD submissions for South Africa.

South Africa-v1.0


Attribute	Description
Applicant	The name of the applicant/HCR (Holder of Certificate of Registration) submitting the eCTD.
Application Number	The number issued for the product by the MCC (Medicines Control Council). The Application Number remains from the first data submission for the full lifecycle of the product. Multiple comma-separated values can be provided.
Dosage Form	The dosage form of the medicinal product. Multiple comma-separated values can be provided.
Duplicated Applications (Proprietary Names/Dates of Application)	The name of the multiple/duplicate applications of the medicinal product (include, even if the name is not yet approved) plus the application date of the duplicate applications. Multiple paired values can be provided.
eCTD Sequence	The sequence number of the data submission. The default is from the Sequence Code, but can be overridden.
INN	The recognised International Non-proprietary Name should be given for the active ingredients and pharmaceutical drug if available. It should be written in all lower-case letters and provided exactly as officially listed in international lists and without abbreviations (for example, WHO INN, British Approved Names (BAN), United States Pharmacopoeia (USP)).
Proof of Efficacy	The data type submitted as proof of efficacy, and a description of the data type if "other" is selected as data type. Multiple paired values can be provided.
Proprietary Name	The name of the medicinal product. Include even if not yet approved. Multiple comma-separated values can be provided.
Related Sequence	The sequence number of a previous submission to which the submission relates. Multiple comma-separated values can be provided.
Submission Type	The type of regulatory submission to which the data submission relates.

South Africa-v2.1


Attribute	Description
Applicant	The name of the applicant/HCR (Holder of Certificate of Registration) submitting the eCTD.
Application Number	The number issued for the product by the MCC (Medicines Control Council). The Application Number remains from the first data submission for the full lifecycle of the product. Multiple comma-separated values can be provided.
Dosage Form	The dosage form of the medicinal product. Multiple comma-separated values can be provided.
Duplicated Applications (Proprietary Names/Application Numbers)	The name of the multiple/duplicate applications of the medicinal product (include, even if the name is not yet approved) plus the application number(s) of the duplicate applications. Multiple paired values can be provided.
eCTD Sequence	The sequence number of the data submission. The default is from the Sequence Code, but can be overridden.
INN	The INN of the API(s) accompanied by its salt or hydrate form (if relevant) or chemical description of the API(s). Multiple comma-separated values can be provided.
Proprietary Name	The name of the medicinal product. Include even if not yet approved. Multiple comma-separated values can be provided.
Related Sequence	The sequence number of a previous submission to which the submission relates. Multiple comma-separated values can be provided.
Submission Type / Proof of Efficacy	The type of regulatory submission to which the data submission relates followed. The type of regulatory submission is followed by data type submitted as proof of efficacy, and a description of the data type if "other" is selected as data type. Multiple paired values can be provided for the Proof of Efficacy, each bound to the specific submission type.

South Africa-v3.1


Attribute	Description
Application ID	A unique 14-character identifier number automatically issued by SAHRA for an application once it is created on SAHPRA Application Portal. Application ID is used for all sequences of an eCTD application and cannot be changed.
Application Number	A unique number automatically issued by SAHPRA for each product, strength, replica/clone/duplicate once an application is created or a new replica/clone is added to the existing application on SAHPRA Application Portal. Multiple comma-separated values can be provided.
Application Type	The type value for the Application.
APIMF Number	A unique identifier number of certified Active Pharmaceutical Ingredient Master File (APIMF). Populated, if APIMF is referenced in the eCTD application. Multiple comma-separated values can be provided.
Contact	Applicant contact data. Multiple contacts can be provided in the envelope if needed, but adding at least one local applicant contact is required. The following values must be provided for each contact: Contact Name, Contact Email, Contact Type.
Dosage Form	The dosage form of the medicinal product.
INN	The recognised International Non-proprietary Name should be given for the active ingredients and pharmaceutical drug if available. It should be written in all lower-case letters and provided exactly as officially listed in international lists like WHO INN, British Approved Names (BAN), United States Pharmacopoeia (USP) and so on without abbreviations. Multiple comma-separated values can be provided.
Multiple Applications (Application Number/Proprietary Name)	Multiple Application Indicator of any replicas/clones/duplicates with proprietary name and application number for each additional application. Multiple paired values can be provided (both Application Number and Proprietary Name must be either populated or empty).
PMF Number	A unique identifier number of certified Plasma Master File (PMF). Populated, if PMF is referenced in the eCTD application. Multiple comma-separated values can be provided.
Proprietary Name	The name as proposed or registered. For API Master Files, insert drug substance name and APIMF holder name. Multiple comma-separated values can be provided.
Related Sequence	The attribute is used to group sequences associated with the same submission. This helps the agency qucklier evaluate sequences associated with a particular submission. Multiple comma-separated values can be provided. If the submission type does not set to Response to a pre-registration recommendation or post-registration, then the Related Sequence attribute must set to NONE.
Sequence Date	Indicating the date of a sequence was being submitted. The date should correlate but should not necessarily be identical to the date shown in the Letter of Application and the Application Form. The Sequence Date is mainly used to ensure the validity of the codes taken from the Defined Lists.
Sequence Number	Four-digit sequence number matching the sequence folder being submitted.
Sequence Description	The Sequence Description attribute gives the Applicant the opportunity to better describe what is being done in the Sequence.
Sequence Type	Contains all the Sequence-related information. It identifies what is happening to the Submission with the Sequence being submitted. Only one Sequence attribute can be specified per Sequence, however, multiple types of Responses can be specified as types. Responses can only be combined with other responses. Multiple values can be provided Values for Sequence Type are taken from Sequence Maintenance > Sub Filling Type Values Data Administration List.
Submission (Submission Type/Evaluation Pathway/Submission Lead/Submission Number)	Contains all the submission-related information for the regulatory activity that is not related to a specific sequence. Multiple Submission sets can be provided if the combination is allowed in the Submission Type Matrix. For Submission Type, values are taken from Display Name attribute in the Sequence Maintenance > Filling Type Values Data Administration List. For Evaluation Pathway, values are taken from Display Name attribute in the Submission Maintenance > Evaluation Pathway Values Data Administration List. For Submission Lead, values are taken from Display Name attribute in the Submission Maintenance > Regulatory Activity Lead Values Data Administration List.
SMF Number	The Site Master File (SMF) Number for all manufacturers referenced in the eCTD application. Multiple comma-separated values can be provided.
VAMF Number	A unique identifier number of certified Vaccine Master File (VAMF). Populated, if VAMF is referenced in the eCTD application. Multiple comma-separated values can be provided.

JavaScript must be enabled in order to use this site.Please enable JavaScript in your browser and refresh the page.

eCTD Attributes South Africa

You can use the following attributes to describe eCTD submissions for South Africa.

South Africa-v1.0


Attribute	Description
Applicant	The name of the applicant/HCR (Holder of Certificate of Registration) submitting the eCTD.
Application Number	The number issued for the product by the MCC (Medicines Control Council). The Application Number remains from the first data submission for the full lifecycle of the product. Multiple comma-separated values can be provided.
Dosage Form	The dosage form of the medicinal product. Multiple comma-separated values can be provided.
Duplicated Applications (Proprietary Names/Dates of Application)	The name of the multiple/duplicate applications of the medicinal product (include, even if the name is not yet approved) plus the application date of the duplicate applications. Multiple paired values can be provided.
eCTD Sequence	The sequence number of the data submission. The default is from the Sequence Code, but can be overridden.
INN	The recognised International Non-proprietary Name should be given for the active ingredients and pharmaceutical drug if available. It should be written in all lower-case letters and provided exactly as officially listed in international lists and without abbreviations (for example, WHO INN, British Approved Names (BAN), United States Pharmacopoeia (USP)).
Proof of Efficacy	The data type submitted as proof of efficacy, and a description of the data type if "other" is selected as data type. Multiple paired values can be provided.
Proprietary Name	The name of the medicinal product. Include even if not yet approved. Multiple comma-separated values can be provided.
Related Sequence	The sequence number of a previous submission to which the submission relates. Multiple comma-separated values can be provided.
Submission Type	The type of regulatory submission to which the data submission relates.

South Africa-v2.1


Attribute	Description
Applicant	The name of the applicant/HCR (Holder of Certificate of Registration) submitting the eCTD.
Application Number	The number issued for the product by the MCC (Medicines Control Council). The Application Number remains from the first data submission for the full lifecycle of the product. Multiple comma-separated values can be provided.
Dosage Form	The dosage form of the medicinal product. Multiple comma-separated values can be provided.
Duplicated Applications (Proprietary Names/Application Numbers)	The name of the multiple/duplicate applications of the medicinal product (include, even if the name is not yet approved) plus the application number(s) of the duplicate applications. Multiple paired values can be provided.
eCTD Sequence	The sequence number of the data submission. The default is from the Sequence Code, but can be overridden.
INN	The INN of the API(s) accompanied by its salt or hydrate form (if relevant) or chemical description of the API(s). Multiple comma-separated values can be provided.
Proprietary Name	The name of the medicinal product. Include even if not yet approved. Multiple comma-separated values can be provided.
Related Sequence	The sequence number of a previous submission to which the submission relates. Multiple comma-separated values can be provided.
Submission Type / Proof of Efficacy	The type of regulatory submission to which the data submission relates followed. The type of regulatory submission is followed by data type submitted as proof of efficacy, and a description of the data type if "other" is selected as data type. Multiple paired values can be provided for the Proof of Efficacy, each bound to the specific submission type.

South Africa-v3.1


Attribute	Description
Application ID	A unique 14-character identifier number automatically issued by SAHRA for an application once it is created on SAHPRA Application Portal. Application ID is used for all sequences of an eCTD application and cannot be changed.
Application Number	A unique number automatically issued by SAHPRA for each product, strength, replica/clone/duplicate once an application is created or a new replica/clone is added to the existing application on SAHPRA Application Portal. Multiple comma-separated values can be provided.
Application Type	The type value for the Application.
APIMF Number	A unique identifier number of certified Active Pharmaceutical Ingredient Master File (APIMF). Populated, if APIMF is referenced in the eCTD application. Multiple comma-separated values can be provided.
Contact	Applicant contact data. Multiple contacts can be provided in the envelope if needed, but adding at least one local applicant contact is required. The following values must be provided for each contact: Contact Name, Contact Email, Contact Type.
Dosage Form	The dosage form of the medicinal product.
INN	The recognised International Non-proprietary Name should be given for the active ingredients and pharmaceutical drug if available. It should be written in all lower-case letters and provided exactly as officially listed in international lists like WHO INN, British Approved Names (BAN), United States Pharmacopoeia (USP) and so on without abbreviations. Multiple comma-separated values can be provided.
Multiple Applications (Application Number/Proprietary Name)	Multiple Application Indicator of any replicas/clones/duplicates with proprietary name and application number for each additional application. Multiple paired values can be provided (both Application Number and Proprietary Name must be either populated or empty).
PMF Number	A unique identifier number of certified Plasma Master File (PMF). Populated, if PMF is referenced in the eCTD application. Multiple comma-separated values can be provided.
Proprietary Name	The name as proposed or registered. For API Master Files, insert drug substance name and APIMF holder name. Multiple comma-separated values can be provided.
Related Sequence	The attribute is used to group sequences associated with the same submission. This helps the agency qucklier evaluate sequences associated with a particular submission. Multiple comma-separated values can be provided. If the submission type does not set to Response to a pre-registration recommendation or post-registration, then the Related Sequence attribute must set to NONE.
Sequence Date	Indicating the date of a sequence was being submitted. The date should correlate but should not necessarily be identical to the date shown in the Letter of Application and the Application Form. The Sequence Date is mainly used to ensure the validity of the codes taken from the Defined Lists.
Sequence Number	Four-digit sequence number matching the sequence folder being submitted.
Sequence Description	The Sequence Description attribute gives the Applicant the opportunity to better describe what is being done in the Sequence.
Sequence Type	Contains all the Sequence-related information. It identifies what is happening to the Submission with the Sequence being submitted. Only one Sequence attribute can be specified per Sequence, however, multiple types of Responses can be specified as types. Responses can only be combined with other responses. Multiple values can be provided Values for Sequence Type are taken from Sequence Maintenance > Sub Filling Type Values Data Administration List.
Submission (Submission Type/Evaluation Pathway/Submission Lead/Submission Number)	Contains all the submission-related information for the regulatory activity that is not related to a specific sequence. Multiple Submission sets can be provided if the combination is allowed in the Submission Type Matrix. For Submission Type, values are taken from Display Name attribute in the Sequence Maintenance > Filling Type Values Data Administration List. For Evaluation Pathway, values are taken from Display Name attribute in the Submission Maintenance > Evaluation Pathway Values Data Administration List. For Submission Lead, values are taken from Display Name attribute in the Submission Maintenance > Regulatory Activity Lead Values Data Administration List.
SMF Number	The Site Master File (SMF) Number for all manufacturers referenced in the eCTD application. Multiple comma-separated values can be provided.
VAMF Number	A unique identifier number of certified Vaccine Master File (VAMF). Populated, if VAMF is referenced in the eCTD application. Multiple comma-separated values can be provided.