CA: Health Canada publishes information about filing of Post-Notice of Compliance changes in eCTD format

Health Canada announced the launch of the Notices of Change (Level III) Form in fillable PDF format to support the new guidance on Post-Notice of Compliance (NOC) Changes. The PDF SmartForm can be found on the Health Canada website and can be completed electronically with Adobe Reader or Adobe Acrobat version 8.2 or higher.

Once successfully completed, printed and signed, the forms for:

• human drugs should be scanned and sent to Health Canada in electronic format only to the Submission Information and Policy Division (SIPD) on CD/DVD, along with the Annual Drug Notification
• veterinary drugs should be sent to Health Canada in paper format to the Veterinary Drugs Directorate (VDD) on an annual basis.

Supporting data should not be submitted together with the level III changes. One form should be completed to include all level III changes per drug product for that year. Health Canada advises sponsors to include the maximum number of completed forms/drug products that will fit per CD/DVD as possible in order to  minimize the number of CDs/DVDs. CDs/DVDs for human drugs should be submitted in individual slim jewel cases and only the discs should be labelled.

The requirements for the CD/DVD labelling are as follows:

• Sponsors name
• "Protected B"
• Virus free certification, the software used for the virus check and the date of the virus definition file or files
• Month and year of the submission
• Disc number and total number of discs (for example, Disc 1 of 3).

eCTD Requirements (applies to human drugs only):
Health Canada requests that all level III change forms be submitted in eCTD format, if they are related to a previously filed submission for a drug product in eCTD format. The level III form should be filed as a leaf element under the "m-1-2-8-other-application-information" subheading.  The naming convention used for the leaf is up to the sponsor's discretion, however meaningful names should be applied. Furthermore, "ADMIN" should be used as the submission type for the level III forms.

[Source: Health Canada website]

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