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Regulatory Affairs Services

Expert Regulatory Affairs Services for Health Products

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, as outlined on this page.

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Establishment Licences

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:

  • Drug Establishment Licence (DEL)
  • Site Licence (SL) if you are importing NHPs
  • Medical Device Establishment Licence (MDEL)
Prescription Drugs

Prescription Drugs

  • DIN Applications
  • Post Approval Changes
  • Annual Drug Notification
  • Drug labelling review
  • Orphan Applications
  • Paediatric Supplements
  • Adaptation of CTD Formats for New Markets
  • Dossier Review and Gap Analysis
  • Review and Advice on CMC, Non-clinical and Clinical Dossiers
  • Administrative Applications
  • Labelling Updates
Natural Health Products

Natural Health Products

  • Product Licence Applications
  • Product Licence Amendments
Medical Devices

Medical Devices

There are four classes of medical devices, Class I, II, III and IV.  We have the experience to do the following:

  • Classify your medical device products and determine if a device licence is required
  • Prepare the Medical Device Licence Application (MDL) and submit to Health Canada
Cosmetics

Cosmetics

Cosmetics marketed in Canada need to meet the minimum requirements. The following are typical requirements which we can assist or manage for you:

  • Review of formulations
  • Review of labels
  • Registration of cosmetic products
OTC (non-prescription) DIN applications

OTC (non-prescription) DIN applications

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