Position paper 5 April 2023

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.