Guidance

A guide to defective medicinal products

Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).

• From: Medicines and Healthcare products Regulatory Agency
• Published: 22 July 2005
• Last updated: 2 August 2021 — See all updates

Documents

A guide to defective medicinal products

PDF, 863 KB, 36 pages

This file may not be suitable for users of assistive technology.

Request an accessible format.

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Details

This guidance is on defective medicines and substances used in their manufacture or packaging which may also be defective.

The guidance doesn’t cover:

• errors or near-miss incidents
• adverse drug reactions
• quality defects in or incidents involving medical devices
• quality defects in or incidents involving veterinary medicinal products

Published 22 July 2005
Last updated 2 August 2021 + show all updates

1. 2 August 2021

   Updated guide to defective medicinal products

2. 22 July 2005

   First published.