Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID-19) outbreak

AI Summary

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has introduced temporary regulatory flexibilities to support pharmaceutical wholesalers facing supply chain disruptions during the COVID-19 pandemic. This guidance modifies standard expectations for Good Distribution Practice (GDP) and Wholesale Dealer Authorisations (WDA(H)) to ensure the continuous supply of medicines. Key allowances include the deferral of periodic supplier and customer requalification and extending the window for returning medicines to saleable stock to 10 days. Transportation requirements have been eased, permitting non-temperature-controlled transport under specific ambient conditions and allowing products to be held at transit hubs for up to 96 hours without a specific license, provided risk assessments are conducted. Additionally, Responsible Persons (RP) may oversee multiple companies within a corporate group, and facilities may use equipment with limited initial qualification, provided full validation is completed retrospectively. To maintain focus on essential supply, companies may put minor deviation investigations, internal audits, and routine SOP reviews on hold. While these flexibilities do not require prior approval, the MHRA requires companies to document all such decisions locally and report them to a dedicated MHRA email address. Organizations must prioritize patient safety by conducting thorough risk evaluations and maintaining transparency throughout the application of these temporary measures.