HPRA updates April 2021 – Various

The HPRA, Ireland has posted the following updates on its website:

Regulatory submission query form for human medicines

This is a new form and it is available here.

Application form to Withdraw an Authorisation Licence Approval or Registration

The updated application form, version 4 is available here.

Application form for a Manufacturer’s/Importer’s Authorisation

The updated application form, version 13 is available here.

Withdrawal of Authorisations or Certificates for Human Medicines
Updated form

An updated form, version 5 has been posted on the website. You can view it here.

Updated guidance

The guidance document has been updated from version 3 to version 4.

Here, you can view the track changed and the clean versions. The changes to the guidance appear to be non-substantial.

Notification of Marketing Status of Human Medicines
Updated form

An updated form, version 6 has been posted on the website. You can view it here.

Updated guidance

The guidance document has been updated from version 5 to version 6.

Here, you can view the track changed and the clean versions. The changes to the guidance appear to be non-substantial.

Source: HPRA website