The Regulations Amending the Food and Drug Regulations (Veterinary Drugs — Antimicrobial Resistance) were published in the Canada Gazette, Part II and have come into force as of May 17, 2018.
These Regulations amended the Food and Drug Regulations, and included changes that impact pharmacists who fabricate, package/label, test, or import active pharmaceutical ingredients (API) for veterinary use. Specifically, new drug establishment licence (DEL) requirements have been introduced, alongside the associated good manufacturing practice (GMP) requirements.
These changes were previously communicated by Health Canada. Regulations include a transition period for DEL requirements, and this bulletin serves as a reminder that the application deadline for the DEL transition is July 17, 2019.
The DEL transition period allows those who were conducting an activity (fabricate, package/label, test, or import) with respect to veterinary API on or before May 17, 2018, to continue to do so without a DEL under the condition that a DEL application for the activity is submitted before July 17, 2019. Those who choose not to submit an application before July 17, 2019, will not be permitted to conduct licensable activities without a DEL.
If an application is submitted before July 17, 2019, pharmacists for whom the transition applies can continue to conduct licensable activities without a DEL until Health Canada renders a decision on their application. After a decision has been made on the application, a DEL may be issued, and the applicant will have to comply with the DEL including any terms and conditions. If Health Canada does not issue a DEL, the applicant will have to cease unlicensed activities.
It is important to note that pharmacists, health care practitioners, and veterinarians require a DEL to import antimicrobials API for veterinary use that are on List A: List of Certain Antimicrobial Active Pharmaceutical Ingredients. Pharmacists, health care practitioners and veterinarians are subject to the transition period above and are expected to submit a DEL application by July 17, 2019, or cease importation on July 17, 2019.
To ensure the application is identified as subject to the transition period, and to avoid shipments being delayed at the border, please include the following:
- a cover letter which clearly indicates that the application is submitted under the transitional provisions outlined above, with a statement indicating whether or not licensable activities related to active ingredients for veterinary use were being conducted on or before May 17, 2018;
- A FRM-0033 that clearly indicates that the application is an API application for API for veterinary use (Table 2 and section 3.1, for importers); and
- for importers, a completed copy of the most recent version of Table A, which can be requested at hc.del.questions-leppp.sc@canada.ca.
If and application has already been submitted and the information mentioned above was not provided, please send an email to hc.el.applications-le.sc@canada.ca indicating the associated application number and any missing information.
For more information about the requirements, you can consult the following resources:
- DEL Q&As – Anti‐Microbial Resistance Regulatory Amendment
This document provides an overview of the regulatory changes in a Q&A format. - Health Product Inspections and Licensing Blog (GC Collab)
The blog contains all the DEL bulletins issued by Health Canada. If you are not registered to the blog and need help to register, please contact hc.del.questions-leppp.sc@canada.ca. - The following DEL bulletins include information about API for veterinary use:
- DEL bulletin #24 includes 2 recorded webinars. One is an introduction to the new requirements under the Food and Drug Regulations affecting industry and healthcare practitioners who compound veterinary drugs. The other is about how to submit an application or an amendment to a drug establishment licence for veterinary API.
- DEL bulletin #25 includes information about DEL and GMP requirements for API for veterinary use.
- Atypical API lists—the list of atypical APIs for human use IS applicable to veterinary drugs:
