Regulatory Requirements of DIN Issued Products
By: Joanna Chudyk, M.SC., REGULATORY AFFAIRS SPECIALIST, email
What is a Drug Identification Number (DIN)?
Drugs in Canada (over the counters, hard surface disinfectants, veterinary drugs, new drugs) require registration in order to be sold in the Canadian market. Once a drug is approved, Health Canada will assign a Drug Identification Number (DIN); an eight-digit number unique to each product. The DIN number is required to appear on the front panel of all drug products and act as proof of product authorization. There are a number of different drug submission categories each with their own requirements, costs, and timelines, all of which can be found in the Food and Drug Regulations. The type of data available, claims made, and whether a monograph or precedent product is available will all influence the application.
Products that do not require a Drug Identification Number (DIN) include medical devices, natural health products, veterinary health products, pest control products, and cosmetics. However, these product types all have their own registration process and requirements. If you’d like to learn more about the requirements for these products, please visit Dell Tech’s news page or the applicable Health Canada guidance document.
Regulatory Requirements of DIN Issued Products
Drug Identification Number products (DIN’s) cover a wide range of different products; from hard surface disinfectants to non-prescription drugs, each with their own registration requirements. If your product does not comply with a drug product monograph, then sufficient evidence will be required to support the products safety and efficacy for approval, for example, clinical trials and toxicological data. Once a submission is completed and a Drug Identification Number (DIN) is issued, the manufacturers (DIN owner’s) responsibility does not end. Annual Drug Notification Form’s (ADNF’s) must be submitted on a yearly basis to confirm all information at Health Canada is up-to-date and accurate in order to continue selling in the Canadian Market.
In this article, we’ll review the regulatory requirements as per the Food and Drug Regulations for products that have a Drug Identification Number, updating Health Canada, and how Dell Tech can help with your Drug Identification Number (DIN) status.
Understanding the Regulatory Requirements for Drug Identification Numbers (DINs)
Drug Identification Number (DIN) registration requirements can vary significantly depending on the product. For example, some categories of non-prescription drugs have an associated Health Canada Category IV Monograph, which outline labelling requirements, dosage forms, active ingredients, directions of use, and risk information. If your product does not comply with a monograph, or if a monograph does not exist for your drug product category, then additional safety and efficacy data is required. Typically, studies need to be Good Laboratory Practice (GLP) for non-clinical data or Good Clinical Practice (GLC) for clinical data, in addition to other protocol requirements as per the applicable Health Canada guidance document. The following Monographs are currently available for attestation:
- Acne Therapy (2021)
- Sunscreen Monograph (2022)
- Medicated Skin Care Products (2018)
- Diaper Rash Products (2018)
- Anti-Dandruff Products (2018)
- Antiseptic Skin Cleansers (2021)
- Athletes Foot Treatments (2018)
- Throat lozenges (2018)
- Hard Surface Disinfectant (2015)
Updating Health Canada with your Drug Identification Number (DIN)
As per the Food and Drug Regulations, once a Drug Identification Number (DIN) product is registered, it’s important to keep Health Canada up to date on any changes to your product. There are a number of post-licensing activities that exist for drugs such as amendments, administrative changes, or post-DIN changes (PDC). Each specific change has varying requirements. A PDC is a notification that can be made at no cost and changes can be implemented prior to Health Canada’s approval, although we strongly recommend you refrain from making any modifications until approval is received. PDC’s should be filed within 30 days of making the change. Amendments require pre-approval from Health Canada prior to implementing the change and have an associated cost. Some examples of post-licensing changes include:
- Change in name of the manufacturer
- Revision to labelling or rate of medicinal ingredient delivery
- Addition or revision to therapeutic/non-therapeutic claims
- Addition, revision, or removal of a non-medicinal ingredient
Conditions and restrictions do exist for each change and this information can be found in the Health Canada guidance documents.
How can Dell Tech Laboratories provide assistance with carrying out your DIN Status?
Once Health Canada issues a Drug Identification Number (DIN) or Notice of Compliance (NOC), the manufacturer (licensee) receive a Drug Notification Form (DNF) and the Drug Product Database (DPD) updates to notify the public of its availability status. The status of a drug is listed as the manufacturer updates Health Canada of its status on the Canadian market. The status of a drug may be listed as:
- Canceled Pre-market
- Cancelled Post-market
- Canceled (Safety Issue), and
- Canceled (Unreturned Annual)
Please see the guidance document for further information on these categories.
As required under the Food and Drug Regulations, manufacturers must update Health Canada when the status of a drug changes. Some examples of required notifications are:
Market Notification – Health Canada requires a manufacturer to submit a notification of the drug going to market within 30 days of the first sale of that drug. This is accomplished by completing and submitting the issued Drug Notification Form. In some cases, the current market label must be submitted along with the Drug Notification Form (DNF).
12 Months Without Sale Notification – A manufacturer is obligated under the Food and Drug Regulations to report the period of no sales in the Canadian Market to Health Canada after 12 months have elapsed without a sale of the drug. This notification should be made within 30 days.
Discontinuation of sales notification – A manufacturer must notify Health Canada of the discontinuation of the sale of its drug within 30 days after the sale of that drug was discontinued.
An Annual Drug Notification Form (ADNF) must be submitted by the manufacturer on a yearly basis confirming whether every product is dormant or marketed. The Annual Drug Notification Form (ADNF) also acts as an attestation that all information provided by the manufacturer (DIN owner) is up-to-date and accurate. Failure to provide a completed Annual Drug Notification Form (ADNF) will result in the status of the drug changing to “Canceled (unreturned annual)” in the Drug Product Database (DPD).
How will the biocide regulations impact DIN’s?
The Biocide Regulations are intended to consolidate and streamline the existing regulations for biocides (hard surface disinfectants, surface sanitizers, pesticides). The anticipated launch date for these new regulations is Spring 2024 and will bring new submission requirements for biocide products. Food contact sanitizers, which historically did not require registration, will need to be registered.
There is limited information on how Drug Identification Number submissions (DIN’s) currently in queue will be affected and what the exact changes to the registration process will be. Dell Tech continues to stay informed on any announcements related to the Biocide Regulations. Contact us at any time or sign up for our newsletter to stay up-to-date on these changes and any other regulatory changes that may affect your products.
Do you require assistance identifying the submission requirements for your drug product? Are you unsure if your label and formula are compliant with the Food and Drug Regulations? Would you like assistance in submitting your Annual Drug Notification Form (ADNF)? Dell Tech can help!