Prescription and non-prescription drugs, Natural Health Products, Cosmetics and Class II, III and IV Medical Devices all require product licences. For example prescription and non-prescription products have a product licence typically referred to as a Drug Identification Numbers or DIN.
Businesses performing any regulated activities such as fabricating, packaging, distributing, importing, wholesaling and testing of any of the aforementioned health products need to have specific site establishment licences:
The type of Licence required is dependent on the type of health product you want to import, wholesale or distribute in Canada. If you wish to be an importer, wholesaler or distributor of a prescription drug you will require a Drug Establishment Licence (DEL) or if you wish to manufacture or import a Natural Health Product (NHP) you will require a Site Licence.
Our consultants can help you with the application process for obtaining the following licences:
Our consultants have the direct experience with Health Canada to provide the following services:
OTC (non-prescription) DIN applications
Natural Health Products
There are four classes of medical devices, Class I, II, III and IV. We have the experience to do the following:
Cosmetics marketed in Canada need to meet the minimum requirements. The following are typical requirements which we can assist or manage for you: