Guidance for Manufacturers Specials licence holders on ‘packing down’ medicines during the coronavirus (COVID-19) outbreak

AI Summary

The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance regarding the 'packing down' of large medicinal packs into smaller quantities during the COVID-19 pandemic. Normally, Manufacturer Specials (MS) license holders are restricted from packing down for retail sale under General Sales Legislation. However, to prevent shortages, the MHRA permits MS holders to distribute these products to community pharmacies temporarily. Key regulatory requirements include notifying the MHRA via email with a specific Excel spreadsheet detailing the shortage and packaging details. Labels must include the site's MS number, and every pack must contain a Patient Information Leaflet (PIL). All operations must remain compliant with Good Manufacturing Practice (GMP) obligations. Additionally, pharmacists in retail settings may prepare medicines for sale if done on-site and without advertising. This flexibility is strictly limited to the duration of the COVID-19 outbreak. While no specific violations by a single company are listed, the document sets clear boundaries to prevent unauthorized distribution outside these emergency protocols. These measures ensure that local supply chains remain functional while upholding safety and information standards for patients receiving redistributed medications.