Establishment Site Licensing

What's the purpose of Establishment Site Licensing

A Drug Establishment License (DEL) is required for any person in Canada who wishes to fabricate, package/label, test, import, distribute or wholesale a finished dosage drug. The establishments where these activities take place must undergo inspection and demonstrate Good Manufacturing Practices (GMP), as outlined by the Food and Drug Regulations. The DEL is renewed annually.

Foreign sites whose drugs are to be imported by Canadian importers are listed on the importer’s Foreign Site Annex. These sites are also inspected for GMP compliance. A foreign site can only be listed on the foreign site annex to a DEL after it has proved to be GMP compliant.

An NHP site license is required for any person in Canada who acts as a manufacturer, packager, labeller, and/or importer of NHPs for sale. These activities must be carried out according to Good Manufacturing Practices (GMP). It is the responsibility of the Canadian importer to ensure that products coming from a foreign site meet Canadian GMP requirements. The foreign site is listed on the importer’s site license. The NHP Site Licence is renewed annually.