Amendments to the Food and Drug Regulations regarding the use of antimicrobial drugs in animals will come into force beginning on November 13, 2017.1 Nearly 80% of the antimicrobial drugs sold in Canada are for use with animals. The amendments aim to mitigate health risks associated with antimicrobial resistance by increasing the regulatory oversight of antimicrobials for veterinary use while introducing an alternative, less burdensome pathway for low-risk veterinary health products (VHPs). This bulletin provides an overview of the amendments.
What You Need To Know
- Increased quality standards: veterinary active pharmaceutical ingredients (APIs) imported or sold in Canada must be manufactured in accordance with good manufacturing practices (GMPs); a drug establishment licence (DEL) will be required for persons who import, fabricate, package, label or test veterinary APIs.
- "Own use importation" of unauthorized veterinary drugs for food-producing animals will be restricted to List B Drugs.
- Sales volume information: manufacturers, importers and compounders of veterinary antimicrobials will be required to report annual sales of medically important antimicrobial drugs to Health Canada by the intended animal species.
- A notification program for veterinary health products (VHPs) will be implemented for low-risk veterinary health products described on List C used in maintaining or promoting the health and welfare of companion and food-producing animals.2 Companies will be required to:
- notify Health Canada 30 days before selling a VHP or making a change to a marketed VHP;
- have a label on the VHP that reads "Veterinary Health Product";
- report to Health Canada any serious adverse drug reactions; and
- meet the GMPs in the Natural Health Products Regulations (NHPR).
- Significance of the amendments include:
- increased compliance cost associated with new GMP and DEL for persons who import, fabricate, package, label or test veterinary APIs;
- increased costs associated with sales volume reporting;
- restricted access to unauthorized veterinary drugs through own use importation; and
- facilitated access and reduced compliance cost for manufacturers and importers to legally market VHPs as a result of the new notification program.
Antimicrobial resistance due to the use of antimicrobial drugs is a growing global health concern. Nearly 80% of the antimicrobial drugs sold in Canada are for use with animals. The new amendments to the FDR are intended to mitigate antimicrobial resistance problems.
Increase Quality Standards
The current law excludes veterinary APIs from both GMP requirements and the need for a DEL. The amendments require persons who fabricate, package, label, import or test a veterinary API to do so in accordance with a DEL. This requirement also applies to any person who imports, for the purpose of compounding, an antimicrobial for veterinary use set out on List A.3
These new rules for veterinary APIs take effect on May 17, 2018. There is an additional 14-month transition period ending July 17, 2019 to submit a DEL application. Veterinary APIs that fall under the definition of natural health product (NHP) will be regulated under that regime and exempt from the above requirements.
Restriction on Own Use Importation
Currently, veterinary APIs unauthorized for sale in Canada may be imported into Canada for personal use in food-producing animals under "own use importation." Effective November 13, 2017 the amendments prohibit the importation of a drug for the purpose of administering it to a food-producing animal or animal intended for consumption if its sale would contravene the Food and Drug Act (FDA) or regulations. The exceptions are the drugs on List B, which contains veterinary drugs that may be imported but not sold in Canada despite not being authorized for sale by Health Canada. Food animal producers will no longer be able to import unauthorized drugs for their own use except for List B drugs. Drugs may be added to this list by Health Canada.
Sales Volume Reporting
The amendments introduce a new reporting requirement for manufacturers and importers who sell veterinary drugs in dosage form that contains List A ingredients and for persons who compound such a drug. Starting with sales from the year 2018, an annual report must be provided to the Minister of Health identifying the total quantity sold or compounded and an estimate of the quantity sold or compounded for each intended animal species. The deadline for the sales volume report is March 31 of the following year.
Notification Program for VHPs
VHPs could be used as additional tools for managing the health of animals and potentially reduce the need to use antimicrobials. The new notification program formalizes the voluntary Interim Notification Pilot Program (INPP), which was aimed at providing oversight and facilitating the sale of VHPs. The objective of the program is to create a flexible and risk appropriate mechanism for manufacturers and importers to access low risk products for use in companion and food-producing animals.
A VHP is a drug described on List C in dosage form. The list contains active, homeopathic and traditional medicines or substances permitted in VHPs. Health Canada will amend this list from time to time. A VHP cannot be manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of the disease, disorder or abnormal physical state, or its symptoms. This means products making general health claims will be considered to be VHPs, whereas prescription drugs and drugs containing List A ingredients will not be.
Manufacturers and importers of VHPs will not be required to obtain Drug Identification Numbers (DINs) or hold DELs. However, GMP requirements of the NHPR apply to these products, and a label stating "Veterinary Health Product"; is required. In addition, manufacturers and importers will be required to notify Health Canada at least 30 days before commencing the sale of a VHP or making a change to a marketed VHP. Although not required by regulation, Health Canada intends to verify each VHP to ensure it has been correctly notified.
The amendments require manufacturers or importers to report any VHP serious adverse drug reactions to Health Canada. Furthermore, the Minister can require the manufacturer or importer to provide information if there are reasonable grounds to believe the VHP is no longer safe. The Minister will be able to stop the sale if no or insufficient information is provided, or if the sale represents a contravention of the FDA or FDR. The Minister will be able lift a direction to stop sale if the situation giving rise to the stop sale did not exist or has been corrected.
To discuss these issues, please contact the author(s).
This publication is a general discussion of certain legal and related developments and should not be relied upon as legal advice. If you require legal advice, we would be pleased to discuss the issues in this publication with you, in the context of your particular circumstances.
For permission to republish this or any other publication, contact Janelle Weed.
© 2019 by Torys LLP.
All rights reserved.