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.

eCTD Attributes China

You can use the following attributes to describe eCTD submissions for China.