Notice – New regulatory activity types for filing to the Marketed Health Products Directorate (MHPD)

June 21, 2019
Our file number: 19-110267-954

This notice serves as a confirmation of the new regulatory activity (RA) types to be used in lieu of the Undefined Data Post-market Vigilance (UD-PV), filed to the Marketed Health Products Directorate (MHPD). The confirmation of the new RA types is in accordance with the feedback received during the external consultation period.

Thus far, the UD-PV regulatory activity type has been used for a variety of regulatory transactions filed to MHPD. In order to process these transactions more efficiently, Health Canada has assigned distinct new RA types to more accurately reflect the information contained within. Health Canada will begin accepting the below listed new RA types, in lieu of UD-PV, effective August 1, 2019.

With each new RA type, a list of possible regulatory transaction (sequence) descriptions has also been developed to further identify the information contained in the transaction. The regulatory transaction description list is available upon request using the "Filing Submissions Electronically" information page on the Health Canada website, and will be updated to reflect the new RA types prior to August 1, 2019.

The table below provides a detailed comparison of the current process with use of UD-PV against the new process using the new regulatory activity types, effective August 1, 2019.

Table 1: Comparison of the current process with use of UD-PV against the new process using the new regulatory activity types
Use of: Current Process

(to be decommissioned July 31, 2019)
New Process

(as of August 1, 2019)
Regulatory Transaction in eCTD format Must be built as per the Canadian Module 1 schema version 2.2a requirements, using the UD-PV regulatory activity type, until the schema has been updated. Must be built as per the Canadian Module 1 schema version 2.2a requirements, using the UD-PV regulatory activity type, until the schema has been updated.
Cover Letter (when provided) Must include the following:

Regulatory activity type:
  • UD-PV
Regulatory transaction description:
  • As per table 4 of the Guidance Document: Creation of the Canadian Module 1 Backbone.
Must include the following:

Regulatory activity type:
  • PA-PV
  • REG-PV
  • IRSR-PV
  • RC-PV or
  • PSA-PV
Regulatory transaction description:
Regulatory Enrolment Process (REP) Templatesb Transactions for REP dossiers must include the following in the REP templates:

Regulatory activity type:
  • UD-PV
Regulatory transaction description:
  • As per dropdown list provided in the REP templates.
Transactions for REP dossiers must include the following in the REP templates:

Regulatory activity type:
  • PA-PV
  • REG-PV
  • IRSR-PV
  • RC-PV or
  • PSA-PV
Regulatory transaction description:
  • As per drop-down list provided in the REP templates.
  1. Health Canada does not have information regarding the next version of the Canadian Module 1 schema.
  2. The REP requirements apply only to companies enrolled in REP, filing a regulatory transaction for a REP dossier.

As per the Notice - Mandatory Use of eCTD Format, published on the Health Canada website, UD-PVs are mandatory in eCTD format as of June 1, 2019. Consequently, as of August 1, 2019, the new RA types, filed in lieu of UD-PV, will also be mandatory in eCTD format.

Please send comments or questions regarding this notice to hc.ereview.sc@canada.ca.

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