CMDh and other updates – February 2022

Information update on Periodic Safety Update Reports (PSURs)

Updated information has been provided on a number of points concerning PSURs. The inforation answers a ragne of questions including the following:

  • Should EU HBDs also be used for PSURs for generic products?
  • How should it be indicated that a PSUR is based on an EU HBD?
  • Which reference safety information is to be used in PSURs for generic prodcuts?

You can view the updated information here.

Source: HMA website

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

The above procedural advice document has been updated from the version of 20 December 2021 EMEA-H-19984/03 Rev. 96 to the version of 4 February 2022 EMEA-H-19984/03 Rev. 97.

Updates have been made to the responses to the following questions:

  • 4.5. How shall I present my Extension Application?
  • 23.4. What information should be reported to the Agency on the marketing status of CAPs?
  • 23.6. How to report marketing status updates to the Agency for CAPs?
  • 23.11. Which information does the Agency publish about the marketing status of EU medicinal products?

Here you can view the track changed and clean versions of the document.

Source: European Medicines Agency