Publication of Regulations Amending the Fees in Respect of Drugs and Medical Devices Regulations

Notice to Stakeholders

Publication of Regulations Amending the Food and Drug Regulations (DIN Requirements for Drugs Listed in Schedule C to the Food and Drugs Act that are in Dosage Form) in Canada Gazette, Part II.

Publication of Regulations Amending the Fees in Respect of Drugs and Medical Devices Regulations
(DIN Requirements for Drugs Listed in Schedule C to the Food and Drugs Act that are in Dosage Form) in Canada Gazette, Part II.

December 13, 2017

Dear Stakeholders,

Health Canada announces the publication of Regulations Amending the Food and Drug Regulations (DIN Requirements for Drugs Listed in Schedule C to the Food and Drugs Act that are in Dosage Form) and Regulations Amending the Fees in Respect of Drugs and Medical Devices Regulations (DIN Requirements for Drugs Listed in Schedule C to the Food and Drugs Act that are in Dosage Form) in Canada Gazette, Part II, on December 13, 2017.

The objective of this regulatory amendment is to apply the requirement to have a Drug Identification Number (DIN) to Schedule C Drugs, in order for a drug to be sold in Canada. Along with the new requirement for all Schedule C drugs to have a DIN, the labelling requirements have also been updated to reflect the new requirement: instead of requiring the Establishment Licence number to be on the label, there will now be a requirement for the DIN to be on the label.

You can read the amendments in Canada Gazette, Part II: [LINK]

These amendments will come into force on June 13, 2018. Health Canada is requesting that all applications for a DIN be submitted by December 13, 2018.

In an effort to reduce the operational burden of these amended regulations, there will be a transition period to allow authorization holders time to submit applications for DINs and also to update the respective product labels. This transitional provision will only apply to market authorization holders of Schedule C Drugs which have already received a market authorization.

Information on new responsibilities and how market authorization holders of Schedule C Drugs can apply for DINs as well as information on the transition period can be found in the attached document.

Contact Information
Office of Policy and International Collaboration
Biologics and Genetic Therapies Directorate
Health Products and Food Branch
Health Canada
Building #6, 100 Eglantine Driveway
Tunney’s Pasture
Ottawa, ON K1A 0K9
Address Locator: 0601B
Fax number: (613) 952-5364
BGTD.OPIC@hc-sc.gc.ca