Dossier ID request form for pharmaceutical/biologic dossiers

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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.

A dossier ID must be requested prior^* to filing the first regulatory transaction:

• When filing in eCTD format;
• When switching from non-eCTD electronic-only format to eCTD format;
• When filing in non-eCTD format using the Regulatory Enrolment Process (REP).

^*A request for a dossier ID should only be placed a maximum of eight weeks prior to filing a regulatory transaction.

If you are using the REP, have an existing dossier ID, and are continuing to file in the same format (eCTD or non-eCTD), there is no need to request a dossier ID. You may proceed by completing the RT XML template and send the regulatory transaction via the electronic submission gateway (ESG).

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: client.information@hc-sc.gc.ca. In addition, previously issued correspondence, such as acknowledgment letters or screening acceptance letters, may be used to retrieve the dossier ID. If you are unsure what your product dossier ID is, submit a completed dossier ID request form. Based on the request, Health Canada will confirm the dossier ID.

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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: Regulatory enrolment process (REP): Drugs for human/veterinary use, disinfectants and biocides.

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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. For division 8 drugs, 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. For division 1 drugs, the product name must be established at the time the dossier ID request is submitted.

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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 (/).

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Footnote 5

Indicate the regulatory activity type you will submit as your first filing under this dossier ID, i.e. NDS, ANDS, NC, DINA, Level 3 Change etc. For the full list of eligible regulatory activity types, refer to the eCTD or non-eCTD guidance document.

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Footnote 6

If the Dossier ID request is for an Administrative Submission, identify the reason and provide the additional information listed below:

1. Changes in product ownership - Indicate if all DINs are being transferred
2. Mergers and buyouts - Provide name of the original DIN owner and/or DIN number(s)
3. Additional product names - Provide details (for example, existing name and new product name)
4. 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 Involving Human or Disinfectant Drugs.

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Footnote 7

For information and list of regulatory activities mandatory in eCTD format refer to the Guidance Document: Preparation of Regulatory Activities in eCTD Format.

For information on non-eCTD format refer to the Guidance Document: Preparation of Regulatory Activities in non-eCTD format.

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Footnote 8

As per section 4.1 of the eCTD Guidance Document, if you are filing a Division 1 or Division 8 transaction in eCTD format for the first time to Health Canada, a sample in eCTD format is required. The information in these sections will allow Health Canada to assess whether a sample would be required. In certain cases, more than one sample is required per company, depending on the type of the eCTD transaction being filed.

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Footnote 9

1. If you have a control number that has been issued for pre-submission meetings associated with this product, provide the control number.
2. If there was previously filed DSUR associated with the product, provide the control number.
3. Provide the intended indication when the dossier ID request is for a pre-submission meeting or a New Drug Submission
4. Indicate the drug status: prescription, non-prescription, or ethical, and switches from Rx to non-Rx (OTC/NHP)

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Footnote 10

Record the appropriate therapeutic and pharmacological classification for the drug, e.g. calcium channel blocker, biological response modifier, histamine H2-receptor antagonist.

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Footnote 11

Definition of Canadian Reference Product is:

1. 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,
2. 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
3. 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.

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Footnote 12

The Primary contact is the person to be contacted by Health Canada if there are any issues or clarifications required when enrolling a dossier.

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Footnote 13

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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