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

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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.