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Antimicrobial Products for Veterinary Use

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Veterinary Drugs Proposed Changes to Food & Drug Regulations and Establishment Licensing Fees: Active Pharmaceutical Ingredients, Antimicrobial Resistance

By: Joe McCarthy, Senior Regulatory Affairs Specialist, email

On July 2nd Health Canada published proposed changes 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 15st, 2016

http://www.gazette.gc.ca/rp-pr/p1/2016/2016-07-02/html/reg2-eng.php

http://www.gazette.gc.ca/rp-pr/p1/2016/2016-07-02/html/reg3-eng.php

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