Health Canada requirement for pharmacy veterinary compounding (Session 2)

February 15, 2018 10:30 am – 12:00 pm
Digital Distribution – Government of Canada, Ottawa ON

How to submit an application or an amendment to a Drug Establishment Licence veterinary active pharmaceutical ingredients. This is a session for those who are applying for a DEL for the first time or who are amending their current DEL to be in compliance with new rules, as well as to receive information on the sales reporting rules.

Do you import Active Pharmaceutical Ingredients that may be used in veterinary drugs? Are you a pharmacist or veterinarian who compounds antimicrobial drugs on List A for animals? If so, regulatory changes to the Food and Drug Regulations coming into force may affect you.

Starting May 17, 2018, health care professionals and importers may need to be inspected by Health Canada, need to comply with Good Manufacturing Practices (GMP), and need a Drug Establishment Licence (DEL).

Starting March 31, 2019, manufacturers, importers or compounders of antimicrobial drugs for veterinary use that contain an active pharmaceutical ingredient on List A will need to report annual sales data to Health Canada. This means data will need to be collected throughout 2018 for reporting by March 31, 2019.

Contact Health Canada today and stay informed!

Additional Information

You will find additional information on these new rules on the page. GMP and DEL guidance documents for human active pharmaceutical ingredients (APIs) can be applied to veterinary APIs and are being updated as needed.

Registration Information

Health Canada will be offering webinars in French and English in February 2018. To receive important updates by email, including invitations to the upcoming webinars, send an email to DEL_Questions_LEPPP@HC-SC.GC.CA using the subject line “AMR Info Request”.