eCTD Module 1

eCTD Module 1

Module 1
Administrative Information and Prescribing Information

The name of the folder for module 1 should be m1.

This module contains administrative information that is unique for each region. Regional guidance will provide the specific instructions on how to provide the administrative forms and detailed prescribing information.

Country (national or EU / USA / Japan)
  • Application number centralised application Number or MRP procedure number
  • Calibri;”>Agency-name picklist value in the most recent EU m1 eCTD specification
  • Submission type picklist value in the most recent EU m1 eCTD specification
  • Procedure type picklist value in the most recent EU m1 eCTD specification
  • Invented-name trade name
  • INN The International non-Proprietary name for the drug substance
  • Sequence The sequence number here must match the sequence number in the folder structure
  • Related-sequence
  • Submission-description This element is used to describe this particular eCTD sequence

Country In the centralised procedure, there should only be one envelope with the entry ‘emea’. For MRP/DCP, each country in the procedure needs to have a separate envelope entry. Common must not be used as a country identifier in the envelope.
Application number The application number should be the centralised procedure/application number (EMEA/H/C/…), MRP/DCP procedure number (e.g. SE/H/1234…) or other national application or licence number as required by NCAs. Multiple entries are possible. The full application number including the regulatory activity identifier should be used if known.

Applicant Entries for ‘applicant’ should be consistent for all eCTDs from any single applicant (legal entity), as they define where eCTDs are stored in internal systems. Consistency of spelling is also relevant over time to allocate the eCTD correctly.
Agency-name Self explanatory, from picklist in the most recent EU m1 eCTD specification. Assure that Country and Agency name will be consistent.
ATC If unknown at the time of submission, the entry can say ‘to be confirmed’.
Submission type From picklist, see m1 specification for further details.
Procedure type From picklist, see m1 specification for further details.
Invented-name The trade name/invented name for the medicinal product covered by the application. If the eCTD covers multiple strengths or dosage forms, this entry does not need to describe the complete name, a simple entry, for example, ‘Wonderdrug’ will suffice.
INN The International non-Proprietary name for the drug substance.
Sequence The sequence number here must match the sequence number in the folder structure.
Related-sequence For a description and example of how to use the ‘related sequence’ entry
12. April 2012Permalink