Post-pandemic GDP: end of extensions and new guidelines for pharmaceutical distribution

The COVID-19 emergency has also profoundly affected the pharmaceutical distribution sector, leading to extraordinary measures to ensure supply continuity. These include the automatic extension of Good Distribution Practice (GDP) certificates, which allowed companies to maintain uninterrupted operations despite logistical and inspection challenges. These extensions ended at the end of 2024: regular inspections were fully resumed in 2025, restoring compliance to the top priority for all operators in the supply chain.

A clarification from the EMA (April 2024) also further defined the role of the Responsible Person (RP): the possibility of carrying out certain activities remotely remains, but only with express authorization from the national competent authority. In general, the RP must continue to operate within the EU/EEA to ensure direct supervision and traceability of operations.

In this "new normal," companies must prepare for a double level of control: on-site inspections and remote audits, adopting best practices that include process digitalization, ongoing staff training, and document transparency throughout the supply chain.

Want to learn more about how to adapt your organization to the new challenges of pharmaceutical distribution? Explore our guides and discover best practices for ensuring compliance and resilience in your business.