Preparation of veterinary Drug Identification Number submissions
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About
Veterinary Drug Identification Number (DIN) submissions are covered by Part C - Division 1 of the Food and Drug Regulations for drugs that are not considered “new drugs” (hereafter called “Division 1 drugs”). This page does not cover new drugs or generic drugs for veterinary use.
- New drugs are covered by Part C - Division 8.
- Refer to the Guidance for Industry Preparation of Veterinary New Drug submissions.
- For generic drugs, refer to the Guidance for Industry - Preparation of Veterinary Abbreviated New Drug Submissions - Generic Drugs.
Learn more about:
- Part C - Division 1
- Part C - Division 2 Good Manufacturing Practices (GMPs)
- Part C - Division 8
- Guidance on drug establishment licences (DEL): List A API for veterinary use
- Guidance for Industry Preparation of Veterinary New Drug submissions
- Guidance for Industry - Preparation of Veterinary Abbreviated New Drug Submissions - Generic Drugs
Who can apply
This page provides information to assist veterinary drug manufacturers (sponsors) in preparing a well-structured DIN submission to facilitate screening and review by Health Canada’s Veterinary Drugs Directorate.
Drug sponsors must follow Part C - Division 2 and obtain a drug establishment licence (DEL) as per Part C - Division 1A.
If you’re filing a Veterinary DIN submission for an Antiseptic Teat Solution, consult the Antiseptic Teat Solutions Monograph. It outlines the conditions of use and labelling permissible under the Division 1 Regulations.
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Before you apply
This section includes important information to help sponsors assess whether their product is eligible for review as a Division 1 drug.
A Division 1 drug must be comparable to one or more drug products previously approved under Division 1 in all of these areas:
- Active ingredients or combination of active ingredients (including salt)
- Strengths
- Dosage form
- Conditions of use:
- indications
- intended species
- dosages
- routes of administration
- methods of reconstitution
To search for Division 1 products that are comparable in these 4 areas, refer to the Drug Product Database for information on drugs authorized for sale by Health Canada.
Products approved under Division 8, considered “new drugs”, cannot be used as comparable products for review of a Division 1 drug. Information about "new drugs" is available in the Notice of Compliance database.
If you’re unsure whether your product is considered a Division 1 drug, refer to Classification of products for use in animals for steps to confirm a classification.
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Non-medicinal ingredients
The non-medicinal ingredients (also called ‘inactive ingredients’ or ‘excipients’) don’t need to be comparable to other Division 1 drugs. However, we will evaluate them during review to ensure they:
- are harmless in the amounts used
- do not provide any therapeutic effect
- do not adversely affect the efficacy or safety of the active ingredients
- are used at a level not in excess of the amount required to accomplish the intended effect
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How to apply
In order to file a DIN submission, you must supply us with:
- A cover letter stating the purpose of the submission and the justification for the Division 1 status of your product, that is, the identification of the comparable and approved Division 1 drug(s).
- A Product Information Template and a Regulatory Transaction Template completed via the Regulatory Enrolment Process (REP).
- To learn more about the REP and access relevant resources and tools, refer to the Submission format section below. Please note that as of October 1, 2022, REP filing is mandatory for DIN submissions.
- Copies of all labelling (including package insert, inner labels and outer labels) in both English and French.
- Save all labelling components and package sizes in one Microsoft Word document.
- If available, submit mock-up labels.
- Include a version date (same date on all documents) in the footer of each page.
- Include a signed and dated Attestation that the French matches the English version.
- An original, signed and dated version of the Veterinary Drug Submission Application and Fee Form, which also outlines the applicable fees.
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Submission format and filing process
REP filing is mandatory as of October 1, 2022.
You must file your submission through the Common Electronic Submission Gateway (CESG). Consult the REP guidance documents below.
For help with the CESG or REP, please contact:
Email: ereview@hc-sc.gc.ca
Contact the Submission and Knowledge Management Division for information on procedures and guidance in effect at the time of filing and for any further clarification surrounding submissions:
Email: vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca
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After you apply
Our Veterinary drugs - Management of regulatory submissions guidance provides more details about how we manage submissions, such as:
- timelines
- decisions
- clarification requests
During the review
We’ll assess the information you provide us and may request more to help us make a decision. Response times depend on the complexity of the submitted information. If your product is considered to have a New Drug status, we will inform you and provide an opportunity to justify or revise your product. We may request information in support of safety, efficacy and quality in certain cases.
During review, we assess if the labelling uses the proper and most up to date wording of the conditions of use and warnings. This includes the withdrawal period if the drug is for food-producing animals.
We’ll use the veterinary Prescription Drug List and Controlled Drugs and Substances Act during the review to assign one or more schedules to your product based on the active ingredient(s) and determine if the product requires a prescription.
If the submission is considered to be acceptable, your product will receive a DIN. It will not receive a Notice of Compliance (NOC).
Filing updated information after you have a DIN
If you want to make any changes after we issue your DIN, you can file through one of these pathways:
- Administrative DIN
For changes to a drug product that do not need scientific assessment, such as changes in brand or manufacturer name. File your submission with the Administrative Changes - Certification Form For Veterinary Drugs, along with the items listed below. - Change to DIN
For any other change to the product or labelling, file a Change to DIN. We may need additional justification to adequately assess the acceptability of the change. During review, we may propose the filing of a New Drug Submission if the change falls within the definition of New Drug as stated in Division 8 of the Regulations.
As part of the submission, the sponsor must submit:
- a cover letter stating the nature of the change and a rationale for the change
- updated Product Information Template through REP (if applicable)
- updated Regulatory Transaction Template
- copies of the revised set of product labels and package inserts to reflect the change (if applicable)
- Administrative Changes – Certification form for Veterinary Drugs (applicable to administrative DIN submissions)
- Veterinary Drug Submission Application and Fee Form (applicable to administrative DIN submissions)
If the manufacturer has changed after a corporate merger, buy-out or licensing agreement, provide a letter from the initial sponsor that authorizes the:
- transfer of submission sponsorship to the new sponsor
- cross-reference to the initial sponsor’s file, indicating which elements are being authorized for cross-reference
Contact us
Contact us with any questions related to DIN submissions.
Email: vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca
Related links
- Guidance Document Post-Drug Identification Number (DIN) Changes: This has not been formally adopted for veterinary drugs, it is a useful reference to determine how a change may be categorized and what the associated filing requirements may be. Final categorization and filing requirements should be confirmed with VDD.
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