Dossier ID request form for Master Files dossiers

Form

Dossier Information

Master File Type (required) Footnote 2
Format of the regulatory dossier (required)

*If this is a conversion, as per section 2.1.4.1 of the Guidance Document: Master Files (MFs) - Procedures and Administrative Requirements, as a baseline requirement when converting MFs from the non-eCTD format to the eCTD format, the MF Holder or authorized MF Agent must include a copy of the entire MF in their first eCTD transaction

Does your company have experience sending eCTD sequences to Health Canada? (required)

Primary Contact Information (required) Footnote 5

Language of Correspondence (required)

Alternate Contact Information (optional) Footnote 6

Language of Correspondence

Clicking ‘Submit’ will send the completed form to Health Canada and a copy to the email address listed in the ‘Primary Contact Information’ section.

Help Text

Footnote 1

As per the acknowledgement letter issued by the Master File Unit.

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Footnote 2

Refer to section 1.3 Scope and Application; Table 1 of the Guidance Document: Master Files (MFs) - Procedures and Administrative Requirements.

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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.

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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.

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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.

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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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