Assessment of user tested patient information: Information for applicants

The Patient Information Quality Unit is currently receiving a very high volume of applications for assessment of user tested patient information and this has resulted in some delay in processing applications.

We are working to reduce backlogs and minimise delays by employing additional staff and streamlining assessment processes. To help us provide the best possible service and reduce backlogs as quickly as possible, please do not contact us directly or via the patient information mailbox to check the progress of your application unless it is more than 90 days since receiving notification of a start date for the procedure. If you have not received an acknowledgment of your submission or a procedure start date, please follow the advice provided in the FAQs.

Marketing authorisations which have been the subject of an approvable application (see Dear MAH letter of 2 April) or a notification that the product will not be marketed, will be considered compliant with the requirement for user tested patient information.