BHBIA/ABPI guidance on reporting adverse events, product complaints and special reporting situations
The Guidance notes on collecting adverse events, product complaints and special reporting situations during market research are produced by the BHBIA in conjunction with the ABPI. The Guidance Notes were updated in February 2021 to include medical devices.
This document replaces all previous versions.
The Guidance Notes explain what you need to do to meet your obligations to drug safety.
The 2021 Guidance changes include:
The inclusion of:
- Medical device certificate of conformity holders (the equivalent of a medicines marketing authorisation holder - MAH) in section 1.2 Who is it for?
- Medical devices and their definition in section 1.3 What does it cover?
Adding in ‘devices’ and ‘conformity certificate holders’ throughout the Guidance (alongside medicines and MAHs) including within the Data Collection Form, Reconciliation Form, Standard Paragraphs and other Annexes.
Updating the list of relevant legislation in section 1.4 and use of these in the footnotes.
BHBIA members can now view the recording of our webinar held on 18th March. Hear BHBIA and ABPI speakers explain and illustrate the background to the changes and what you need to do now, including practical examples – tune in here
Other useful resources:
The following associated resources are available as word documents, for your convenience when adapting for specific projects (these have been updated in line with the new February 2021 guidance):
We also provide word documents containing suggested wording/standard paragraphs which members can adapt to their own needs for inclusion in questionnaires, guides etc., based on the Annexes in the Guidance notes. See related links on the right.
Our AE/PC/SRS reporting FAQ resource is a selection of real-life queries
from members and the responses from our Ethics Advisor. It supplements
the Guidance Notes, but does not cover all topics – please always check
the main Guidance Notes document first.