Drugs – DIN Application Consulting

Drug Identification Number (DIN) Application Consulting ServicesDrug Identification Number (DIN) application consulting services

What is a Drug?

What is a DIN?

Our DIN Application Consulting Services:

What are the Types of DIN Applications?

Our Drug Label Compliance Consulting Services:

Will Products be Removed from the Market if They Do Not Have a Valid DIN?

 

What is a Drug?

  • When a product is offered for sale in Canada to treat or prevent diseases or symptoms, it is regulated as a drug under the Food and Drugs Act.
  • Drug products include prescription and non-prescription pharmaceuticals, disinfectants and sanitizers.

What is a DIN?

  • A Drug IdentificatioDIN application servicesn Number (DIN) is an eight (8) digit numerical code assigned by Health Canada’s Therapeutic Products Directorate (TPD) for each individual drug product marketed under the Food and Drugs Act and Regulations.
  • A DIN identifies the product including such characteristics as manufacturer, brand name, medicinal ingredient(s), strength of medicinal ingredient(s), pharmaceutical form, and route of administration.
  • Before drug products are authorized for sale in Canada, Health Canada reviews them to assess their safety, efficacy and quality.

Our DIN Application Consulting Services:

  • Search through the Canadian Food and Drug Act and all of its corresponding Regulations to determine all of the regulatory and label requirements.
  • Determine whether all of the ingredients are allowed in Canada. If not, then suggest alternatives.
  • Review the ingredients in the formulation to determine if the product complies with the “fast-track” Category IV monograph or a Labeling Standard, or falls within another DIN category.
  • Determine the fees charged by Health Canada for reviewing each product under the appropriate DIN category.
  • Identify the target review timeline that TPD takes to review the DIN application and the likelihood of success within the chosen category.
  • Determine the types of supporting material which the TPD Canada will probably require to support the label claims for the DIN application category.
  • Determine if there are any minimum & maximum allowable dosages associated with the ingredients.
  • Prepare a DIN application, supporting forms and draft an English version of the label (using MS Word).
  • Submit the application to the TPD on the client’s behalf.
  • If the TPD has any questions or concerns with any specific ingredient(s), label or brand name they will notify us. We will then notify you so that your company has the option to make the necessary revisions to comply with the regulations.
  • Once the DIN is approved, we can also assist the client with their annual Drug Notification Form (DNF) payment.

What are the Types of DIN Applications?

New Drug Submission (NDS), Supplemental New Drug Submission (SNDS), Abbreviated New Drug Submission (ANDS), Supplemental Abbreviated New Drug Submission (SANDS), Investigational New Drug Submission (INDS), and Category IV & Labelling Standard OTC drug applications (for which Health Canada has existing monographs).

Our Drug Label Compliance Consulting Services:

  • As mentioned above, when a DIN application is submitted, it must include a draft of the label (in either English or French).
  • We insert a list of the claims that the TPD may (or may not) allow.
  • Accurately include all of the legally required Risk Information (cautions, warnings, interactions, contraindications, or known adverse reactions / side effects.
  • Correct units for ingredient (mg, mcg, IU, mL, mcg/mL)
  • Determine marketing / advertising claims not allowed (or allowable wording).
  • Information placement (front panel vs. any other panel)
  • Minimum font sizes & contrast for the different sections of the label.
  • Which headings and/or statements must also be bold.
  • Proper format & location of expiry date & lot number
  • Which terms or phrases must be bilingual (or optional), and either provide or source out certain translations.
  • Once the DIN is approved, we then work with the client and/or its graphics / label contractor to ensure the artwork is fully compliant.

Drug label review services

Will Products be Removed from the Market if They Do Not Have a Valid DIN?

If the DIN is found to be falsified, then the product is deemed to pose an unacceptable risk to health, which would warrant removal of that product from sale (drug product recall).

The HPFB Inspectorate would also have ground under section 9 of the Food and Drugs Act, to take immediate action on products making false representation or misleading labels.

All actions will be consistent with the HPFB Compliance and Enforcement Policy (POL-0001). Actions will be taken on products based on the risk priority categories.

Why use a consultant?

Weighing the numerous pros & cons of bringing in a consultant vs. tackling it all in-house?  Please see our web pageWhy Use a Consultantas part of that critical thinking process. Based in British Columbia, but covering all of Western Canada.


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