Veterinary Drugs and Antimicrobial Resistance
For the past few years Health Canada has been actively working on their antimicrobial resistance programs for humans by encouraging responsible use of antimicrobials such as antibiotics in the medical profession. Recently this strategy was expanded to include animals in addition to humans. Over use of antimicrobial agents in animals can contribute to the spread of resistant bacteria which can be transferred to humans through food and direct contact.
Health Canada has implemented regulatory changes to support their AMR strategy with respect to the availability of veterinary drug products, and with respect to requirements for those participating in the veterinary drug product supply chain. As of December 1, 2018, sale of any medically important antimicrobial (MIA) on List A will require a prescription from a veterinarian. Veterinarians have the training to assess and diagnose animal disease, and therefore can ensure that the right treatment is prescribed. All MIAs currently sold over the counter will be reclassified as prescription products and will be sold and distributed like other veterinary prescription drugs in Canada.
Drug Establishment Licenses (DEL) are now mandatory for those groups importing active pharmaceutical ingredients (APIs) for veterinary use. Pharmacists who compound a drug under the supervision of a licensed veterinarian are also required to hold a drug establishment license (DEL) when importing medically important antimicrobials that are on List A. Health Canada has established a 14-month transition period to allow time for the DEL application and inspection process. Groups that had already begun activities with API before May 17, 2018 have been given until July 17, 2019 to submit a complete DEL application. All others who had not yet begun API activities by the May 2018 deadline are prohibited from conducting licensable activities until a Health Canada DEL is received.
Health Canada recommends mock audits as a useful exercise for first-time applicants, when performed by Canadian regulatory consultants with experience in the area of Canadian Good Manufacturing Practices. This will increase confidence and maximize potential for success during any Health Canada inspection triggered by a DEL application.
