The ANVS is granting Eindhoven University of Technology permission for a second cyclotron so the supplier can carry out the required preparatory work. This must be done before the machine can start manufacturing radioactive raw materials for the production of radioactive materials used in patient research. We are tolerating this situation until 31 March 2026, as we expect to grant the final licence on 1 April 2026.
Checking the cyclotron prior to commissioning
Before the university can start manufacturing radioactive raw materials, the cyclotron needs to be functioning properly. To ensure this, the supplier will be carrying out technical acceptance tests in December to check that all components are working as they should. This is similar to an automotive manufacturer checking all the various parts of a car at the factory before it is considered safe to drive. We have granted the supplier a licence for this purpose.
No risk to the environment
Eindhoven University of Technology’s second cyclotron will be installed in a bunker on university grounds on Deurnestraat in Eindhoven. Radiation emissions into the environment during testing should be negligible, as the machine is not producing any radioactive raw materials yet. That means there is no risk to people or the environment. The ANVS will be monitoring the work during testing.
Tolerance to enable quick production of radioactive medicinal products
We are tolerating Eindhoven University of Technology’s installation of a second cyclotron and performance of acceptance tests because the cyclotron’s supplier only has staff with the requisite expertise to do these tests available this year. The supplier installs and tests cyclotrons around the world, and next year’s schedule is already completely full. That would mean postponing production by another year. We are tolerating the situation so production of radioactive medicinal products can start quickly and because we expect to be granting the final licence on 1 April 2026.
Conditions
It is only under strict conditions that the ANVS is permitting Eindhoven University of Technology to install a second cyclotron and have the supplier carry out acceptance tests. This must take place in accordance with the requirements of the existing licence, legislation and regulations and the conditions included in our exemption decision.