Spring Intro 2023

BROMI Self Certified Labels and Leaflets Submissions

3000

2500

2000

1500

2512

2393

1000 Number of cases

1414

1379

500

937

918

0

2017

2018

2019

2020

2021

2022

Year

73

OFFICIAL-SENSITIVE

73

Feedback received and actions

Current guidance does not provide enough information on what changes are acceptable.

 Guidance is being updated and will include practical examples of acceptable changes.

Fear of cases being invalidated and subsequent time delays.

 Review of current process to ensure that only validation issues relating to correct documentation are being raised.

Please let the Product Information Quality Unit know if there is any specific information that you would like to see in the guidance that would enable better use of the self-certification route.

74

74

37