The ANVS is again granting I.D.B. Holland B.V. (IDB) temporary permission to carry out preparatory activities necessary for the production of raw materials for radioactive medicines at its new location in Baarle-Nassau. IDB has already applied to the ANVS for a licence for this purpose. Due to the application’s complexity, licencing is taking longer than expected. The draft decision for the licence to start production was published on 17 October 2025.
Image: © Novartis
Compliance with international legislation
IDB wishes to test an additional production line at its new location to ensure compliance with international legislation. The company is asking our permission for these activities. Testing will result in residual radioactive materials being left behind in the installation. IDS wants us to continue tolerating this state of affairs until 31 December 2026 at the latest, as all preparatory activities should be complete by then.
Testing of additional production line through 31 March 2026
IDB has permission to test an additional production line through 31 March 2026, but cannot start production yet. The testing is intended to enable production of the raw materials for radioactive medicines to start right away once the licence is granted. That would allow more patients to receive treatment.
Through our exemption of these preparatory activities, IDB can start implementing its new method for the production of radioactive lutetium chloride sooner. This production cannot start until we have granted the licence. After that, the old production method can also be phased out. Lutetium chloride is used as a raw material in radioactive medicines. One big advantage of the new production method is that it generates less radioactive waste.
The installation which contains the residual radioactive materials resulting from the preparatory activities may remain in this state until the production licence has been granted, or until 31 December 2026 at the latest. We expect to issue the final licence for all the activities requested in the first quarter of 2026.
Conditions for exemption decision
IDB has our permission to carry out its preparatory activities. Additionally, we are exercising tolerance of the residual radioactive materials left behind in the installation due to these activities. We do not believe that these form a risk to people and the environment. The exemption decision also specifies certain conditions to be met. We will be monitoring IDB’s compliance with these conditions.