Registration of multiple manufacturing sites in one product license
Supply chain resilience is an important component of uninterrupted patient access to products. 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.
In a joint position paper, EFPIA, IFPMA and Vaccines Europe 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.