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Pharmaceuticals

Cosmetics

Medical Devices

Natural Health Products

Pharmaceuticals

In Canada, the Food and Drugs Act defines a drug (pharmaceutical product) as follows:

Any substance or mixture of substances manufactured, sold or represented for use in:

  • the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or the symptoms thereof, in man or animal,
  • restoring, correcting or modifying organic functions in man or animal, or
  • disinfection in premises in which food is manufactured, prepared or kept.

The Act and the Food and Drug Regulations requires that a market authorization or Drug Identification Number (DIN) be issued to all human and veterinary drugs before they can be sold in Canada. Also, in order to sell pharmaceuticals in Canada, manufacturers and importers must obtain and maintain a valid Drug Establishment Licence (DEL).

Normand Robichaud Services conseils inc. can assist you in the following areas:

  • Preparation and filing of market authorization submission (DIN, TPD Category IV Monograph/ Labelling Standard).
  • Communication, liaison and follow-up with Health Canada for DIN modifications or amendments.
  • Preparation, filing and follow-up of Drug Establishment Licence (DEL) submission.
  • Act as your Regulatory Compliance representative in Canada.