Notice - Post-Notice of Compliance (NOC) Changes: Notices of Change (Level III) Form

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Contact: eReview

Notice

March 21, 2012

Our file number: 12-103796-184

Release of Health Canada's updated Post-Notice of Compliance (NOC) Changes: Level III Form

Health Canada is pleased to announce the release of the revised Post-Notice of Compliance (NOC) Changes: Level III form in fillable, Portable Document Format (PDF).

This revision is to support the new Post-Notice of Compliance (NOC) Changes - Quality Guidance Appendix 1 for Human Pharmaceuticals that became effective October 17, 2011.

The revised form includes a new free text field found in section B, which can be used to enter additional details for a specific change, however; this free text field is only available for the following changes:

• When the selection in Section A, "5. Type of Drug", is either "Biologics" or "Radiopharmaceuticals"; or
• When all of the following criteria are met:
  • the selection in Section A, "5. Type of Drug", is either "Pharmaceutical", or "Veterinary";
  • the selection in Section B, "6. Type of Change", is "Level III (Safety and Efficacy)";
  • the selection in Section B, "7. Category of Change", is "Other Changes"; and
  • the selection in Section B, "8. Change", is "Other".

Effective immediately, sponsors should use the revised PDF form available on the Health Canada website.

The PDF SmartForm can be completed electronically with Adobe Reader or Adobe Acrobat version 8.2 or higher. Once successfully completed, printed and signed forms for:

• Human drugs should be scanned and sent to Health Canada in electronic format only.
• Veterinary drugs should be sent to Health Canada in paper format.

As per section "3.3 Supporting Data - Level III Changes" in the Guidance Document: Post-Notice of Compliance (NOC) Changes: Quality Document, supporting data should not be submitted with the Level III changes.

The scanned electronic copy of the signed Level III changes form for human drug products should be sent to the Submission Information and Policy Division (SIPD) along with the Annual Drug Notification, as per C.01.014.5 of the Food and Drug Regulations. Alternatively, Health Canada strongly recommends that the Level III changes form be submitted at the same time the changes are implemented.

The media formats acceptable when submitting electronic data to Health Canada are:

• Compact Disc-Recordable (CD-R) conforming to the Joliet specification;
• Digital Versatile Disc-Random Access Memory (DVD-RAM) Universal Disc Format (UDF) standard;
• Digital Versatile Disc-Recordable (DVD+R/-R) recorded in the Universal Disc Format (UDF) standard;

Contact SIPD for other formats that may be acceptable at the time of submission. Media should not be password protected.

The completed paper forms for veterinary drug products should be sent to the Veterinary Drugs Directorate (VDD ) on an annual basis as per C.01.014.5 of the Food and Drug Regulations. Alternatively, Health Canada strongly recommends that the Level III changes form be submitted at the same time the changes are implemented.

The requirements for media labelling are as follows:

• Sponsor name and brand name;
• eCTD Identifier and sequence number, if applicable;
• "Protected B";
• Virus-free certification, the software used for the virus check, and the date of the virus definition file or files; and
• Month and year of the form.

Electronic Common Technical Document (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. As shown in figure 1, the Level III Change form should be filed as a leaf element under the m-1-2-8-other-application-information subheading. Please refer to the Guidance for Industry: Preparation of Drug Submissions in the Electronic Common Technical Document (eCTD) Format for more information on the eCTD folder structure. 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 Change forms.

Figure 1: eCTD Folder Structure

Non-eCTD requirements (applies to human drugs only)

For the Level III Change forms not submitted in eCTD format, sponsors are to submit in electronic format as a pdf file. As per figure 2, the form should be filed in the subfolder "1.2.8 Other Application Information" using the structure template recommended in the Notice to section "1.6 Electronic Review Documents" of the Draft Guidance for Industry: Preparation of New Drug Submission in the CTD Format. The naming convention used to name the PDF file is up to the sponsor's discretion; however meaningful names should be applied.

Figure 2: Folder Structure for non-eCTD formats

Should you have any questions regarding the content of this notice, please contact:

Submission and Information Policy Division (SIPD)
Therapeutic Products Directorate
Health Canada
Finance Building 2
101 Tunney's Pasture Driveway
Tunney's Pasture, Address Locator 0201A1
Ottawa, Ontario
K1A 0K9
Email: ereview@hc-sc.gc.ca

Veterinary Drugs Directorate (VDD)
Holland Cross Complex
Tower A, Ground Floor, Suite 1411
11 Holland Avenue, Address Locator 3000A
Ottawa, Ontario
K1A 0K9