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Health Canada Webinar Follow-Up: Antimicrobial Resistance Regulatory Amendment

April 10, 2018

By May 17, 2018, veterinarians, pharmacists, or those compounding a drug on the direction of a licensed veterinarian must do so in an establishment holding a Drug Establishment Licence when importing medically important antimicrobial active pharmaceutical ingredients. Read more.
 
Health Canada held webinars in February 2018 pertaining to the Antimicrobial Resistance Regulatory Amendment affecting veterinary drugs.
 
  • Session 1: An introduction to the new requirements under the Food and Drug Regulations affecting industry and health care practitioners who compound veterinary drugs, held on February 13, 2018 (PowerPoint).
  • Session 2: How to submit an application or an amendment to a Drug Establishment Licence for veterinary active pharmaceutical ingredients, held on February 15, 2018 (PowerPoint). 
Health Canada has made available copies of the presentation slide decks, the presentation recordings, and the Antimicrobial Resistance Regulatory Amendment, Questions and Answers document. 

Recordings: 

View Drug Establishment Licence Questions and Answers Antimicrobial Resistance here.


Further Information 

  • For questions related to the Drug Establishment Licensing Requirements, please contact the Drug Establishment Licensing Unit at DEL_questions_LEPPP@hc-sc.gc.ca.
  • For questions related to Good Manufacturing Practice Requirements, please contact the Good Manufacturing Practices Headquarters Unit #1 (Domestic) at GMP_Questions_BPF@hc-sc.gc.ca.
  • For importers with questions related to submissions in support of demonstrating GMP compliance of foreign buildings where licensable activities are conducted with respect to drugs, please contact Foreign_Site_Etranger@hc-sc.gc.ca.
  • For questions related to the Veterinary Antimicrobial Sales Reporting requirements for drugs set-out on List A or to obtain a copy of the API reporting spreadsheet, please contact the Veterinary Drugs Directorate at hc.VAMSR-VAMVR.sc@canada.ca
  • Questions on the management of the inventory of medically important antimicrobials during the transition to December 1, 2018? Visit the Canadian Animal Health Institute website.
To stay up to date on other information about the upcoming Health Canada rule changes, visit the Veterinary Oversight of Antimicrobial Use in Animals in Canada section of the CVMA website.