Suspension of Establishment Licence

The Inspectorate may suspend an establishment licence under the authority provided in the Food and Drug Regulations and Medical Device Regulations where there are reasonable grounds to believe that any provisions of the Acts and Regulations have been contravened or that the licence has made a false or misleading statement in its application for an establishment licence.

Drugs

All Canadian drug establishments as of January 1, 1998 must hold an establishment licence to fabricate, package, label, distribute, import, wholesale, or test a drug. This licensing requirement applies to all Canadian drug establishments except those solely dealing with natural health products, for which prescriptions are not required, and that are for human use in dosage form. These natural health products include traditional medicines (i.e. traditional herbal medicines as well as traditional medicines such as Chinese, ayurvedic (East Indian) and aboriginal (North American) medicines), homeopathic preparations and vitamin and mineral supplements. The Inspectorate may amend the terms and conditions of a drug establishment licence if it is believed on reasonable grounds that it is necessary to do so to prevent injury to the health of the consumer.

Medical Devices

The Inspectorate may also suspend an establishment licence in the case of a medical device, if the failure to suspend an establishment licence would constitute a risk to the health or safety of patients, users or other persons.