Post-Drug Identification Number (DIN) Changes

Post-Drug Identification Number (DIN) Changes

All drugs subject to the Food and Drug Regulations are required to gain premarket authorization prior to issuance of a Drug Identification Number (DIN). After gaining authorization to market a drug, a sponsor may for various reasons wish to make changes to the drug or the information associated with the drug. For those drugs regulated under Part C, Division 1 of the Regulations (“Old Drugs”) the sponsor must comply filing requirements for post-DIN changes when undertaking any changes.

Health Canada recognizes that any change to a drug may impact the safety, efficacy or quality of that drug and/or the safe and effective use of that drug. To manage these risks, Health Canada requires the sponsor of a drug that has received a DIN and is not a New Drug to report changes to the drug via a DIN Application or Notification and any data (if applicable) to support the change.

Post-DIN changes filed through a Drug Identification Number (DIN) Application

The changes included in this reporting category shall be filed, along with any recommended supporting data, to Health Canada as a DIN Application. Any change that requires a DIN application to be filed may not be implemented prior to the review of the supporting data by Health Canada and confirmation that this data is acceptable in support of the change. If acceptable, a new DIN may be issued, or the existing DIN may be retained for the changed drug, and a No Objection Letter will be issued.

Examples of changes included in this reporting category:

  • Change in name of the manufacturer for a human, veterinary or a disinfectant drug.
  • Addition or change to the authorized route of administration.
  • Addition, deletion or change, including quantity, to the medicinal ingredients of the product.

Post-DIN changes filed through OSIP or SKMD Notification

The changes included in this reporting category should be filed, along with any recommended supporting documentation, to Health Canada as a notification, within 30 days of the change being implemented as defined in the Regulations. These notifications do not necessitate assessment by Health Canada.

Health Canada may, upon receipt of the notification:

– update its records;

– uphold the change;

– request that the change be undone, or;

– request that a DIN application be filed to support the change.

Although the sponsor is allowed to submit these notifications within 30 days of making the change, it is strongly recommended that notification be provided to Health Canada prior to the sale of the drug to enable a risk assessment of the change, and thus, better ensure the safety, efficacy and quality of the drug.

Examples of changes included in this reporting category:

  • Any change in the name of the Canadian importer of the product listed on the original HC/SC 3011.
  • The name of the contact for the Drug Identification Number ownership, regulatory contact and/or billing contact changes.

Post-DIN changes filed through Post-Authorization Division 1 Change, PDC/VPDC

The changes included in this reporting category should be filed, along with any recommended supporting documentation, to Health Canada as a notification, within 30 days of the change being implemented as defined in the Regulations. These changes will be assessed by Health Canada and a standard PDC/VPDC has a service standard of 30 days. If the change is deemed acceptable, a No Objection Letter will be sent to the sponsor. If the change is deemed to fall outside the scope of a notification, Health Canada may request the re-filing of a full submission through the issuance of a Not Satisfactory Notice (NSN). Please note that if a NSN has been issued, the sponsor should refile a new PDC/VPDC or other submission to effectuate the authorization of any new revisions or changes.

Examples of changes included in this reporting category:

  • Removing a therapeutic claim, indication, or condition of use (including removal of patient categories, claims about duration, onset of action, sterility etc.).
  • Additions or revisions to the adequate directions for use (that is, warnings, precautions, adverse event information etc.).

Not required to file

For changes where it is indicated in the guidance that no filing is necessary, the sponsor should maintain a record of the change in accordance with GMP and ensure that this information is made available to Health Canada if it is requested at any time.

Examples of changes included in this reporting category:

  • The pharmacopeial standard used at time of original market authorization has been revised (e.g. authorized as United States Pharmacopeia (USP) grade, but USP revises standard).
  • Change to the Universal Product Code, item or lot number.

If you want to be sure your post-authorization changes are in compliance with Canadian regulatory requirements, Quality Smart Solutions has a team of specialists who can assist you. Get prepared now and contact us today to discuss how we can be your solution!

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 11 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Cannabis, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

References

Guidance Document: Post-Drug Identification Number (DIN) Changes, 2019/04/18, Health Canada, https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/post-drug-identification-number-changes.html