New master file request form: Notice

2023-05-01 13:40:00

The 1st of 2023
Our file number: 23-102532-292

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Context

Health Canada is revising the Master File Application Form and merging it with the Drug Master File Fee Form. This update is intended to simplify the application process and reduce the administrative burden for Master File (MF) holders.

This new single FM request web form generates an XML file. This format facilitates the uploading of data into Health Canada’s internal systems, which increases the accuracy, consistency and reliability of the data captured. The form features drop-down lists, predictive text entry, and help text to make data entry quick and easy.

This new MF request web form in XML format will be required for human drug MF transaction requests from June 26, 2023 (excluding transactions relating to FMs of veterinary medicinal products).

Important Information

The new FM application form will come into effect on June 26, 2023. From this date, transactions received that are not submitted using the new application form will be rejected.

The new web form will replace the current PDF versions of the Drug Master File Application Form and the Drug Master File Fee Form.

This XML form will be displayed on:

The form will include detailed instructions on how to complete the form and generate the FM XML file.

You will need to provide this form for each transaction submitted in eCTD or non-eCTD format through the Common Electronic Application Portal.

The form can be found in section 1.2.1 Application forms. YOU it is must not include a separate fee form in Section 1.2.2 Fee Forms.

The fields of the FM application form are interdependent, which means that certain selection lists will adapt according to the options you have already chosen. Make sure you choose the right items from the picklists.

Nsend not fee payment with your FM transaction. Health Canada:

1. will check the type of transaction
2. will charge the corresponding fees
3. send an invoice once the transaction is considered administratively complete

Funding and Fees

Before completing the new form

1. Decide whether you send the FM.xml file in Electronic Common Technical Document (eCTD) or non-eCTD format.
   • All FM news requests must be submitted in eCTD format.
   • If an MF is currently in non-eCTD format, we will still accept transactions, such as updates or letters of access, in non-eCTD format.
2. Read relevant guidance documents and supporting documents.
3. Get Common e-Application Portal accounts.
   • If you don’t have an account, see either of the following:
4. Obtain a case identification number (if needed):
   • FM dossier identification (ID) number in eCTD format: lowercase letter “e” followed by 6 digits
   • FM dossier identification (ID) number in non-eCTD format: lowercase letter “f” followed by 7 digits
     • If you do not know your FM number, please contact the FM Administration Unit.

Contact U.S

If you have any questions regarding the MF filing process, contact the MF Administration Unit.
E-mail : [email protected]

If you have any questions regarding fees or invoices, contact the Cost Recovery team.
E-mail : [email protected]

If you have any questions regarding the new form and submitting applications through the e-portal, contact the Electronic Application Review (eReview) team.
E-mail : [email protected]

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