Drug Establishment License

Drug Establishment License Review

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If you are a Canadian facility working with pharmaceutical products intended for the Canadian market, chances are you will require a drug establishment license (DEL) for your building. According to Part C, Division 2 of Health Canada’s Food and Drug Regulations, you are not permitted to fabricate, package/label, distribute, import, test or wholesale a drug unless you meet the requirements of Health Canada’s Food and Drug Regulations with respect to Good Manufacturing Practices.

Often times a group will go to great lengths to get their drug product registered with Health Canada, but pay little mind to the required licenses for facilities involved with their drug products.

Here’s what you need to know:

  • If your facility is handling drugs in dosage form such as tablets, capsules and solutions or intermediate products or substances that can be used in the preparation of a drug product then these are covered under the definition of a “pharmaceutical product” and you may be required to hold a valid DEL for your activities in Canada.
  • Your building must be inspected by a Health Canada representative before you receive a DEL.
  • Active pharmaceutical ingredient manufacturing facilities have recently been added to the list of facilities that require a DEL (with the exception of Canadian API wholesalers and distributors).

Foreign buildings: while they themselves can’t apply for a DEL, their GMP rating is included in the Canadian importer’s DEL. Information on API sources are required for APIs used in finished drug products intended for Canada.

Other FAQ on Drug Establishment Licenses
Q. How do I know whether or not I am a distributor or a wholesaler according to Health Canada?
A. If you are selling a drug under a name or brand controlled by you, then you are a distributor and you require a DEL. Any Canadian license holder for drug products must be licensed for the activity of ‘distribute’ at a minimum.

BUT – if you are selling drugs (other than at retail) and your name doesn’t appear on the label of the drugs, this means you are a wholesaler and you do not require a DEL for the sale of over-the-counter drugs; but you may need a DEL to sell other types of drugs such as radiopharmaceuticals and narcotics.

Q. What about warehouses and storage locations, do they require a DEL also?
A. Storage and warehouses are expected to abide by Good Manufacturing Practices (GMPs) but they aren’t required to hold a Drug Establishment License. Storage and warehouse groups can consult Health Canada’s guidance document entitled GUI-0069 Guidelines for Temperature Control of Drug Products during Storage and Transportation for details on Health Canada’s expectations for these facilities.

Q. My company is affixing a secondary label to a drug that has already been labelled; do I require a DEL for the Canadian building performing these secondary packaging activities?
A. Secondary packaging may or may not require a DEL, it depends on which type of packaging you are doing: secondary packaging that does not include addition of further labelling information does not require a DEL, an example of this type of operation would be groups assembling multiple products with a see-through packaging material without any additional labelling information.
BUT – if secondary packaging activities involve the addition of a new label to an already labelled container, then a DEL is required.

Q. Where can I find more information on the application for a drug establishment license?
A. Health Canada’s website has many useful facts and tips for applicants, start at http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/directives/gui-0002-eng.php#requ6.