Registration of Multiple Manufacturing Sites in One Product License

Joint Position from EFPIA, IFPMA and Vaccines Europe

Executive Summary

Supply of medicinal products and vaccines is critical for patient access. The registration of multiple manufacturing sites is a key enabler for flexible supply. While most countries allow multiple manufacturing sites in one license, some countries issue a new license for each additional manufacturing site. This often leads to inefficient use of resource and delays in approval due to

• repeated review of a full dossier for additional manufacturing site
• a proliferation of additional licenses requiring long-term maintenance

which ultimately limits supply flexibility.

As industry associations, we urge all countries to adopt a ‘multiple-site-to-one-license’ approach in line with WHO and other guidelines. We believe this will result in a reduction of duplicate work for all stakeholders, help to build agility and speed in supply chain management and improve patient access to medicines and vaccines.