Dossier ID request form for veterinary drug dossiers
Pilot participants only
This dossier ID request form is available to veterinary drug regulatory enrolment process pilot participants only. If you are not a pilot participant, please do not complete this form.
- Footnote 1
If you already have a dossier ID and you are continuing to file in the same format, you do not need to enroll your dossier. You can proceed with your transaction by completing the RT XML template. The Dossier ID should be known from previously issued acknowledgment letter and the format should be HC6-024-x######. If you are unsure what your dossier ID is contact Health Canada at email@example.com.
A request for a dossier ID should only be placed a maximum of four weeks prior to filing a regulatory transaction.
- Footnote 2
The “Company ID” must be obtained from the final company XML file, issued by Health Canada.
- 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 (/). For a clinical trial all the active substances should be listed.
- Footnote 5
- a) If the dossier is in non-eCTD format and needs to switch to eCTD format, provide the Drug Identification Numbers and/or the non-eCTD dossier ID, if available.
- b) If the Dossier ID request is for an Administrative Submission, identify the reason and provide the additional information listed below:
- a. Changes in product ownership - Indicate if all DINs are being transferred
- b. Mergers and buyouts - Provide name of the original DIN owner and/or DIN number(s)
- c. Additional product names - Provide details (for example, existing name and new product name)
- d. Licensing agreements between two manufacturers - Provide product name and company name of the licensor.
Note: transfer of ownership – If the product is already in eCTD format, and all dosage forms, i.e. the complete product is being transferred, the new owner will continue under the same dossier identifier as the one issued to previous owner. Please contact the previous owner for the dossier identifier.
Refer to the Guidance Administrative Processing of Submissions and Applications: Human or Disinfectant Drugs.
- c) If you have a control number that has been issued for pre-submission meetings associated with this product, provide the control number.
- d) Identify the format of your submission i.e., eCTD or non-eCTD electronic only.
- e) Indicate the type of submission i.e. NDS, ANDS, NC, DINA etc.
- f) If there was previously filed DSUR associated with the product, provide the control number.
- g) Provide the intended indication.
- Footnote 6
Record the appropriate therapeutic and pharmacological classification for the drug, e.g. calcium channel blocker, biological response modifier, histamine H2-receptor antagonist, disinfectant.
- Footnote 7
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).
- For more information about Biosimilars, refer to Guidance Document: Information and Submission Requirements for Biosimilar Biologics Drug.
- If ‘No’ is selected, please input ‘N/A’ in the ‘Brand Name’ and ‘Company Name’ fields.
- Footnote 8
The Primary contact is the person to be contacted by Health Canada if there are any issues or clarifications required when enrolling a dossier.
- Footnote 9
The Alternate contact is the person to be contacted by Health Canada if there are any issues or clarifications required when enrolling a dossier, in addition to the Primary contact.
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