Falsified Medicines: MHRA publishes Class 4 FMD Medicines Information
Recommendation
22 October 2026
Good Distribution Practice of Active Substances for Human and Veterinary Medicinal Products
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
The Medicines and Healthcare products Regulatory Agency (MHRA) is currently investigating an incident where several medicines appear to have left the legal supply chain and have then been re-introduced via WDA(H) 50340 HMS Wholesale Limited. This license has since then been terminated.
In a Falsified Medicines Directive (FMD) Alert published 19 March 2020, the MHRA says that "the products do appear to be genuine with legitimate batch numbers. These products are thought to have been stolen from the legitimate supply chain in early 2019 and reintroduced into the supply chain between May and August 2019. This means that the correct transport and storage conditions cannot be guaranteed and while unlikely, could impact their effectiveness."
Only the batch numbers mentioned in appendix 1 of the PDF are within the scope of this alert. You can download the document here.
Related GMP News
30.09.2026European GDP Association Developments May through August 2026
30.09.2026Warehouse Temperature Excursions: What Does the FDA Expect?
30.09.2026Version 4.0 of the Swissmedic Document on Notifications of Changes Published
30.09.2026USA: Court Stops Warehouse Activities Following Persistent Insanitary Warehouse Conditions
30.09.2026GDP Non-Compliance Report: CAPA Measures must not only be Promised but also Implemented
10.09.2026Reminder: Submit your Presentation Proposal for the GDP Forum 2027 by 30 September