Dossier ID request form for Master Files dossiers
Clicking ‘Submit’ will send the completed form to Health Canada and a copy to the email address listed in the ‘Primary Contact Information’ section.
- Footnote 1
As per the acknowledgement letter issued by the Master File Unit.
- Footnote 2
Refer to section 1.3 Scope and Application; Table 1 of the Guidance Document: Master Files (MFs) - Procedures and Administrative Requirements.
- Footnote 3
Refer to Appendix E of the Guidance Document - Preparation of Regulatory Activities in eCTD Format; Figures E-2 to E-15 for Master Files Types II and Figures E-16 to E-19 for Master Files Type III.
In addition, please also indicate Module 3 attributes for the selected structure.
- Footnote 4
Indicate if this is a change in the ownership of the Master File or a Master File Holder Company Name Change.
Note: transfer of ownership – If the Master File is already in eCTD format, i.e. the complete Master File is transferred, the new owner will continue under the same dossier identifier as the one issued to the previous owner. Please contact the previous owner for the dossier identifier.
- Footnote 5
The Primary contact is the person to be contacted by Health Canada if there are any issues or clarifications required when enrolling a dossier.
- Footnote 6
The Alternate contact is the person to be contacted by Health Canada if there are any issues or clarifications required when enrolling a dossier, in addition to the Primary contact.
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