eCTD Attributes Canada
You can use the following attributes to describe eCTD submissions for Canada.
Canada-v2.2
| Attribute | Description |
|---|---|
| Applicant | The company that is submitting the regulatory transaction. |
| Dossier Identifier | The unique identifier assigned to the dossier by Health Canada. The Dossier Identifier is 7 characters: a lower case letter followed by 6 digits. |
| Dossier Type | The dossier type: Biologic Dossier, Drug Master File Dossier, or Pharmaceutical Dossier. |
| Product Name | The product or products that are being addressed in the application |
| Regulatory Activity Lead | Defines which group within Health Canada is expected to take the lead in reviewing the regulatory activity supported by the regulatory transaction. |
| Regulatory Activity Type | The type of regulatory activity: i.e. what regulatory purpose the filing is addressing. |
| Related Sequence Number | The four digit sequence number of the first sequence in the regulatory activity. |
| Sequence Number | The four digit number that is the unique identifier for the sequence (regulatory transaction) inside the overall dossier. |
| Sequence Description | The description of the sequence (regulatory transaction) based upon a series of possibilities defined by Health Canada. |