Drug Establishment Licences

All Canadian drug establishments must hold, since January 1, 1998 an establishment licence to fabricate, package, label, distribute, import, wholesale, or test a drug. This licensing requirement applies to all drug establishments except those solely dealing in some natural health products, for which prescriptions are not required and that are for human use in dosage form, including 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. It is not permit, except in accordance with an establishment licence, to fabricate, package/label, distribute, import or wholesale a drug; or perform tests, including examinations, required under Division 2 of the Food and Drugs regulation.

2011 Drug Establishment Fee Remission Applicants in Respect to Veterinary Use Only (Letter and Form)

Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002) [2011-04-01]

Drug Good Manufacturing Practices (GMP) and Establishment Licencing (EL) Enforcement Directive (POL-0004)

Drug Establishment Licence Application:Forms and Instructions (FRM-0033) [2011-04-01]

GMP Inspection Policy for Canadian Drug Establishments (POL-0011)