Antimicrobial Products for Veterinary Use
By: Joe McCarthy, Senior Regulatory Affairs Specialist, email
Veterinary Drugs Proposed Changes to Food & Drug Regulations and Establishment Licensing Fees:
Active Pharmaceutical Ingredients, Antimicrobial Resistance
On July 2nd Health Canada published proposed changes to the Food and Drug Regulations and Establishment Licensing Fees (Veterinary Drugs) regulations.
The primary intent of the proposed changes is to implement more regulatory oversight of antimicrobials for veterinary use. The proposed changes will restrict own use importation of unlicensed veterinary drugs, sales reporting by species antimicrobials, such as antivirals, antibiotics, antifungals, and antiparasitics.
The proposed regulations also include a new requirement for Veterinary Active Pharmaceutical Ingredients (API) to be manufactured and imported in accordance with Good Manufacturing (GMP) and require persons who import, fabricate, package, label or test veterinary APIs to hold an Establishment Licence (EL).
Veterinary Active Pharmaceutical Ingredients are currently exempt from GMP and Establishment Licence requirements.
The proposed changes are open for comment by interested parties until September 15th, 2016.
Contact:
Dell Tech
Joe McCarthy, Senior Regulatory Affairs Specialist
jmccarthy@delltech.com
519-858-5024
Dell Tech has provided professional, confidential consulting services to the chemical specialty
industry in Canada, the USA, Europe, and Asia for the last 40 years.
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