Notice - Instructions for Submitting Drug Notification Forms (DNF) and Supporting Documents in Electronic Format

December 3, 2010

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Notice

Our file Number: 10-125670-432

Instructions for Submitting Drug Notification Forms (DNF) and Supporting Documents in Electronic Format

Health Canada is pleased to announce the acceptance of Drug Notification Forms (DNFs) and supporting documents in electronic format effective immediately. This Notice provides guidance to assist sponsors in submitting these documents electronically.

DNFs are issued by Health Canada in accordance with section C.01.014.2 of the Food and Drug Regulations (FDR). They contain the drug identification number (DIN) assigned for a drug as well as some of the information included in the drug submission. In accordance with section C.01.014.3 of the FDR, the sponsor must, within 30 days after commencing sale of a drug, date and sign the DNF and return it to Health Canada along with all final labelling materials. Labelling materials include, but are not limited to, marketed notified labels (that is [i.e.], inner and outer labels), package inserts and prescribing information.

Electronic documents will be uploaded onto Health Canada's viewing tool (docuBridge) where they will be immediately accessible to staff. Health Canada will continue to manage the DNF and supporting documents received as per the current process.

The implementation of this Notice is a work in progress. Future refinements may be necessary as a result of experience gained during implementation. Comments on this Notice will be accepted and incorporated as applicable.

1.0 General Requirements

Health Canada strongly encourages sponsors to submit their DNFs and accompanying supporting documents in electronic format as portable document format (PDF) attachments or a zipped Electronic Common Technical Document (eCTD) sequence (when applicable). The documents should be sent via email to the following central location: SIPD-DINREQUEST@hc-sc.gc.ca. Sponsors should verify that the scanned electronic documents are clearly legible.

In order to facilitate the processing of the DNFs and supporting documentation received by email, sponsors should ensure that the following rules and conditions are followed:

• All emails include the following statement in the subject line title: "Division 1 - DNF <Brand Name> or Division 8 - DNF <Brand Name>".
• The body of the email contains only the zipped sequence or PDF files as an attachment. No other documents or submission-related information should be included.
• Each submission includes at least the following three documents:
  1. Cover letter: this document should explain the intent of the package and should address any special requests. The date (mmm,dd,yyy) should be included in the PDF file name.
  2. DNF: the completed, printed, signed, scanned DNF in PDF format.
  3. Labelling material: submitting the final art-work is strongly recommended.
• Each document is saved as a separate PDF file.
• Files provided electronically are not password protected.
• A paper copy of a DNF and supporting data should not be submitted if these documents are submitted electronically.
• With the exception of the file extension, the file naming convention is left to the discretion of the sponsor; however, Health Canada suggests that the file names be kept as brief and meaningful as possible.

1.1 eCTD Requirements

DNFs and supporting documents should be filed in eCTD format only when the previously filed submission for the same drug product was in eCTD format. Sponsors should refer to the Guidance for Industry: Preparation of Drug Submissions in the Electronic Common Technical Document (eCTD) Format for information on preparing the DNF in eCTD format. The following criteria are specific to submissions in eCTD format:

• The DNF should be filed as a leaf element under the m1-2-8-other-application information subheading.
• The supporting documents should be filed as a leaf element under m1-3-2-Inner and Outer Labels subheading as outlined in the eCTD guidance document.
• The sequence containing all the PDF files should be zipped. The zipped file can be named (for example [e.g.], DNF-e123456-0025) and submitted via email.
• The sequence should also contain the Life Cycle Management (LCM) table in PDF format.

Figure 1: Filing structure for eCTD submissions

1.2 Non-eCTD Requirements

When the DNF and supporting documents are not submitted in eCTD format, they should be sent as PDF attachments. If sponsors choose to zip their PDF files, the following naming convention can be used for the zipped file. (e.g. 'DNF- <product name>', Figure 2 illustrates the filing structure that can be used by sponsors if desired.)

Figure 2: Folder structure for non-eCTD submission.

Any questions regarding the content of this Notice should be sent via email to the contact information listed below. In order for your correspondence to be routed appropriately, please indicate "Question: Electronic DNFs" in the subject line.

Health Canada
Health Products and Food Branch
Therapeutic Products Directorate
Submission and Information Policy Division
1st Floor, Finance Building
101 Tunney's Pasture Driveway
Address Locator 0201A1
Ottawa, Ontario
K1A 0K9
Email address: SIPD-DINREQUEST@hc-sc.gc.ca