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.
- Post-Authorization commitments – Post-market Vigilance (PA-PV)
- Post-Authorization Act and Regulations – Post-market Vigilance (REG-PV)
- Issue Related Summary Report – Post-market Vigilance (IRSR-PV)
- Risk Communication – Post-market Vigilance (RC-PV)
- Patient Safety/Advertising Ad-Hoc Post market requests – Post-market Vigilance (PSA-PV)…