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Canada - Proposing amendments to the Food and Drug Regulations to improve the regulatory oversight of antimicrobials for veterinary use

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Canada - Proposing amendments to the Food and Drug Regulations to improve the regulatory oversight of antimicrobials for veterinary use

Department of Healthhas issued notification regarding regulatory proposal to make amendments to the Food and Drug Regulations to improve the regulatory oversight of antimicrobials for veterinary use. The proposed regulations would require veterinary active pharmaceutical ingredients imported or sold in Canada to be manufactured in accordance with good manufacturing practices, require persons that import, fabricate, package, label or test veterinary APIs to do so in accordance with an Establishment Licence, restrict the own use importation of unauthorized veterinary drugs, require manufacturers, importers and compounders of veterinary antimicrobials to provide sales volume information by species, and would introduce an alternative, less burdensome pathway for manufacturers to legally import and sell certain low risk veterinary drugs, known as veterinary health products, that could reduce the need for antimicrobials.

Proposed date of adoption: Normally approximately 12 months following publication in the Canada Gazette, Part I

Proposed date of entry into force: These Regulations would come into force six months after the day on which they are published in the Canada Gazette, Part II. In addition, a transitional provision would allow persons who fabricate, package/label, test and import veterinary active pharmaceutical ingredients would be permitted to continue conducting those activities without an establishment licence, provided that they have applied for one within six months after the coming into force of the regulations.

Final date for comments: 15 September 2016

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures, so that these can be taken up suitably.

 

 


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