What is a Drug?
Drugs include both prescription and nonprescription pharmaceuticals; biologically-derived products such as vaccines, blood derived products, and products produced through biotechnology; tissues and organs; disinfectants; and radiopharmaceuticals. According to the Food and Drugs Act, “a drug includes 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 its symptoms, in human beings or animals;
- restoring, correcting or modifying organic functions in human beings or animals; or
- disinfection in premises in which food is manufactured, prepared or kept.
What is a DIN?
A Drug Identification Number (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.
- Scrutiny through the Canadian Food and Drug Act and all of its corresponding Regulations to determine all of the registration and labeling requirements.
- Review whether there is any ingredients prohibited in Canada. If not, then suggest alternatives.
- Review the ingredients in the formulation to see whether 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.
- 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)
- Category IV & Labelling Standard OTC drug applications (for which Health Canada has existing monographs).
When a non-compliance issue is identified, it is brought to the attention of the company or individual involved. Initially, the Health Products and Food Branch Inspectorate will clarify what is necessary to achieve compliance. It is then the organization or individual’s responsibility to take timely and appropriate action to comply with legislative and regulatory requirements.
- the risk to health and safety;
- compliance history of the regulated party;
- whether the regulated party acted with indifference or premeditation;
- the degree of cooperation offered;
- the likelihood that the same problem will reoccur;
- the likelihood of the enforcement action being effective;
- the need to maintain public confidence in the programs administered by the Health Products and Food Branch (HPFB) and the Inspectorate; and,
- HPFB and Inspectorate priorities and available resources.