Notice: Guidance Document: Post-Drug Identification Number (DIN) Changes

March 17, 2017
Our file number: 17-103112-367

After gaining authorization to market a drug through provision of information under Part C, Section C.01.014.1 of the Food and Drug Regulations (henceforth Regulations) to obtain a DIN, a sponsor may for various reasons wish to make changes to the drug or the information associated with the drug. For those drugs regulated under Part C, Division 1 of the Regulations (for example, drugs that do not fall under the definition of New Drug in Section C.08.001) and which are not eligible to receive a Notice of Compliance (NOC), the sponsor must comply with Section C.01.014.4 when undertaking any changes. This guidance document provides an updated interpretation of Section C.01.014.4 of the Regulations with recommendations on the process for filing changes and the data considered necessary to support those changes.

This guidance document applies to drugs regulated under Part C, Division 1 of the Regulations that have received a DIN pursuant to Section C.01.014.2. This includes pharmaceuticals for human and veterinary use, as well as disinfectant drugs, but excludes biologics and radiopharmaceuticals and any drug that has received an NOC. Please note, the process recommendations for filing changes for veterinary drug products will come into effect once the Veterinary Drugs Directorate has officially published a guidance document on the preparation of veterinary DIN (Division 1 drugs) submissions.

Under the continuous efforts of the Health Products and Food Branch plan to streamline their processes, the following administrative changes have been made to this guidance document.

1. The footnote associated to the requirement to include a "Drug Submission Fee Application Form" with all Notifications and DIN Applications under Section 4.1 "Common Information for Notifications and DIN Applications" was updated. The requirement to provide a Fee Form for applications that do not require fees has been removed. A clarification was added to the footnote to specify that a "Drug Submission Fee Application Form" is only required when there is a fee associated to the application. Therefore, sponsors are no longer required to submit a Fee Form with their Post-authorization Division 1 Change Application (PDC) or Veterinary Post-authorization Division 1 Change Application (PDC).
2. A generic email address was added as a contact for sponsors who wish to receive a blank copy of the Drug Product Information Form to report the addition, revision, or removal of a non-medicinal ingredient under certain conditions in section 4.2.2.1. "Change to the formulation" of the guidance document.

All revisions to this guidance document are effective immediately.

Any questions should be directed to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
1600 Scott Street
Holland Cross, Tower B
2^nd Floor, Address Locator 3102C1
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-4623
Fax: 613-941-1812
E-mail: Policy_Bureau_Enquiries@hc-sc.gc.ca