Dossier ID request form for veterinary drug dossiers
- Footnote 1
A dossier is a collection of all regulatory activities throughout the life cycle of a product for a stakeholder. The format of the Dossier Identifier (ID) is a lowercase letter followed by six (6) unique numbers.
If you already have a Dossier ID, then there is no need to request a new Dossier ID.. You can proceed with your transaction by completing the RT XML template. The Dossier ID should be known from previously issued acknowledgment letter. Dossier IDs for existing submissions filed with Health Canada can be obtained from the Drug Submission Tracking System - Industry Access (DSTS-IA). For information regarding DSTS-IA, or for account set up, please contact the Office of Submission and Intellectual Property by sending an e-mail to: firstname.lastname@example.org. If you are unsure what your Dossier ID is contact Health Canada at email@example.com.
- Footnote 2
Company ID (or company code): is a 5 digit unique number assigned by Health Canada to the manufacturer/sponsor company. For information on the company ID (company code) refer to the sections 2.3 Company Enrolment/Amendment of the Guidance Document: The Regulatory Enrolment Process (REP): Drugs for Human/Veterinary Use and Disinfectant
- Footnote 3
The product name (also known as the brand name or proprietary name) is the name assigned by the manufacturer or sponsor to the dossier (product), and under which the product is to be sold and advertised. The product name is also the name used to identify the product in all submission correspondence, Product Label(s) and Product Monograph/Package Insert, if applicable. If the product name has not yet been determined, the following may be used: "TBD" (short for To Be Determined), the proper or common name of the drug, or the research code.
- Footnote 4
The proper name for a product is the name assigned to the drug in Section C.01.002 of the Food and Drug Regulations, or in boldface type in other Sections of the Regulations or the name of the drug in its finished form identified in the title of a monograph or in any of the official publications listed in Schedule B to the Food and Drugs Act. Example: Acetaminophen, Ferrous Sulphate Tablets.
The common name is the name by which a single ingredient drug is commonly known / designated in scientific or technical journals other than the publications referred to in Schedule B to the Food and Drugs Act. The common name includes the pharmaceutical form when used in relation to the finished drug product.
If there is no proper name and the drug is comprised of a single medicinal ingredient, enter the common name.
If there is no proper name and the drug is comprised of more than one medicinal ingredient, the proper name of the ingredients should be captured and separated by a forward slash (/).
- Footnote 5
Indicate the regulatory activity type you will submit as your first filing under this dossier ID, i.e. NDS, ANDS, NC, Level 3 Change etc. For the full list of eligible regulatory activity types, refer to the non-eCTD guidance document.
- Footnote 6
If the Dossier ID request is for an Administrative Submission, identify the reason and provide the additional information listed below:
- Changes in product ownership - Indicate if all DINs are being transferred
- Mergers and buyouts - Provide name of the original DIN owner and/or DIN number(s)
- Additional product names - Provide details (for example, existing name and new product name)
- Licensing agreements between two manufacturers - Provide product name and company name of the licensor.
Refer to the Guidance Administrative Processing of Submissions and Applications: Human or Disinfectant Drugs.
- Footnote 7
- If you have a control number that has been issued for pre-submission meetings associated with this product, provide the control number.
- Provide the intended indication when the dossier ID request is for a pre-submission meeting or a New Drug Submission
- Indicate the drug status: prescription, non-prescription, or ethical, and switches from Rx to non-Rx (OTC/NHP)
- Footnote 8
Record the appropriate therapeutic and pharmacological classification for the drug, e.g. calcium channel blocker, biological response modifier, histamine H2-receptor antagonist, disinfectant.
- Footnote 9
Definition of Canadian Reference Product is:
- a) a drug in respect of which a notice of compliance is issued pursuant to section C.08.004 and which is marketed in Canada by the innovator of the drug,
- b) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, where a drug in respect of which a notice of compliance has been issued pursuant to section C.08.004 cannot be used for that purpose because it is no longer marketed in Canada, or
- c) a drug, acceptable to the Minister, that can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, in comparison to a drug referred to in paragraph a).
If 'No' is selected, please input 'N/A' in the 'Brand Name' and 'Company Name' fields.
- Footnote 10
The Primary contact is the person to be contacted by Health Canada if there are any issues or clarifications required when requesting a Dossier ID.
- Footnote 11
The Alternate contact is the person to be contacted by Health Canada if there are any issues or clarifications required when requesting a Dossier ID, in addition to the Primary contact.
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