Canadian Pharmaceuticals Regulation
Before drug products are authorized for sale in Canada, Health Canada reviews them to assess their safety, efficacy and quality. Drug products include prescription and non-prescription pharmaceuticals, disinfectants and sanitizers with disinfectant claims.
Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product's safety, efficacy and quality as required by the Food and Drugs Act and Regulations
Through the Veterinary Drugs Directorate (VDD), Health Canada evaluates and monitors the safety, quality and effectiveness, sets standards and promotes the prudent use of veterinary drugs administered to food-producing and companion animals.
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).
How can Innovia Biopharma help you?
✪ 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.
✪ SOP writting
✪ Quality System Implementation
BUSINESS & MARKET DEVELOPMEMENT
✪ Due Dilligence for Merger & Aquisition
✪ Opportunities identification