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Pharmaceuticals

Drug products (OTC and Rx) are regulated under the Food and Drugs Act and must be approved by Health Canada prior to sale on the Canadian market. An 8-digit DIN (Drug Identification Number) on the drug product label signifies Health Canada's approval.

Drug products sold in Canada are regulated under the Food and Drugs Act and are subject to compliance with the applicable Regulations. Market authorization from the regulatory authority (Health Canada) is required in order to legally sell drug products on the Canadian market.

Drug products must undergo a pre-market evaluation by Health Canada where they are assessed for safety, effectiveness and quality. A drug product submission must be prepared and submitted to Health Canada where it undergoes a scientific and regulatory review for the purpose of obtaining product registration for market approval.

FULL ASSESSMENT

DRUG SUBMISSION

What can our consulting services do for you?

  • Provide a full assessment of your product to determine the appropriate regulatory approach and prepare the complete drug product submission for filing to Health Canada.
  • On behalf of you (our client), we can manage the entire drug submission process, including initial submission preparation, filing of the submission to Health Canada, addressing any questions throughout the review process, and we can act as your representative and regulatory authority liaison until product approval is granted.
  • Our services also include a full review of all product labeling and marketing materials.

We prepare the following drug product regulatory submissions to Health Canada:

  • Drug Identification Number (DIN-A)
  • Drug Identification Number – Disinfectants (DIN-D)
  • Drug Identification Number – Category IV (DIN-F)
  • Clinical Trial Application (CTA)

The following are examples of several categories of drug products which are regulated under the Food and Drugs Act and require approval from Health Canada prior to market entry:

  • Antacids
  • Antifungals
  • Acetylsalicylic Acid
  • Acetaminophen
  • Cough and cold drug products
  • Oral decongestants
  • Laxatives
  • Sleep Aids
  • Topical Antibiotics
  • Topical acne therapy products (ingredient dependent)
  • Sunscreens (ingredient dependent)
  • Medicated skin care products (ingredient dependent)
  • Anti-dandruff products (ingredient dependent)
  • Antiseptic skin cleansers (ingredient dependent)
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