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OTC DRUGS CONSULTING
OTC Drugs can range from simple topical creams to more complex products. This category also includes many products that are considered cosmetics in some markets, such as some SPF or Acne Products. Whether you are creating a new product, or enhancing an existing one, we have the know-how to get your product to market.
Drug Identification Number Registration (DIN Numbers)
You may wish to register your Drug Identification Number (DIN Number) to sell your product on the Canadian market as an NHP or if your product is considered a drug. A Drug Identification Number (DIN) is an eight-digit number assigned by Health Canada to show that it has been authorised for sale. Many organisations use DIN numbers to meet global standards for quality control, traceability, and safety. We can assist you with preparing and filing Drug Identification Number (DIN Number) applications and meeting the requirements set out by Health Canada.
Who needs to register their DIN Drug Identification Number?
A Drug Identification Number (DIN) is a unique identifier for health products and devices, including drugs, biologics, and medical devices. The DIN numbers are assigned by Health Canada after a review of the product’s chemistry, manufacturing methods, quality assurance systems, and packaging material. If you want to market your product in Canada as either an NHP or a drug, you will need one or both numbers. Anyone who wishes to sell their product as an NHP or as a drug in Canada must have their DIN registered with Health Canada.
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DIN products must be manufactured in a facility that follows good manufacturing practices (GMP)
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If the facility is based in Canada, that business must obtain a drug establishment license
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Foreign sites must also show evidence that they are following GMP through a Health Canada licensed importer
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DIN products cannot be sold prior to license issuance
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Licensing timelines vary and can be as fast as 45 days.
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Health Canada’s fees for drug license application submissions are due initially upon submission of an application and annually after that.
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The fee varies and increases annually based on the rate of inflation.
DO YOU KNOW?
At The MedNerds, we are committed to providing exceptional services to support your business. Our expertise in regulatory compliance and quality assurance will give you the confidence to navigate the complex landscape of the healthcare industry. Get in touch with us today to learn more about how we can help you.