Permission for IDB to use new production location pending licence
IDB Holland B.V. plans to process the radioactive medicinal raw material lutetium chloride at a new production location. This location was built at their site in Baarle-Nassau but it has not yet been included in their licence. We have decided to grant permission to use the new location. This means IDB will be able to test the production line at the new location. For safety purposes, we are imposing certain conditions. Meanwhile we will continue to process IDB’s application for a licence amendment, which IDB needs to begin using the new production location.
Less radioactive waste
IDB (part of Novartis Netherlands) already has a licence for the production of radioactive lutetium chloride, which is used as a raw material in radioactive medicines. These medicines are used in hospitals for diagnostics and procedures (for example for prostate cancer). Hospitals are increasingly in need of a purer form of lutetium chloride.
IDB has built a new location for the preparation of this purer form, separate from production of the other lutetium chloride. The purer lutetium chloride has the following advantages, and more:
- It results in less radioactive waste (because no long-living variant of radioactive lutetium is created, which did occur in the old production method).
- Fewer raw materials are needed to make the lutetium chloride.
Authority for Nuclear Safety and Radiation Protection working on amending IDB licence
IDB requires an amended licence from the ANVS to use the new production location. This will state how the company needs to handle radioactive substances and radioactive waste, to ensure both the safety of the workers at the location and the environment. We will assess IDB’s application for the amendment of the licence. The assessment and amendment will be carefully performed by us and this takes time. For this reason, IDB has requested permission to begin testing early.
No expected risks associated with an earlier start
We have granted IDB permission to perform these tests at the new production location. This way, IDB can check to see if the production line is working appropriately and whether the lutetium chloride complies with all the requirements for the safe use in patients. We do not expect any additional risks to the surrounding area and the environment. The ANVS issued a licence to IDB some time ago. They have the knowledge and experience to safely use the new production line.
Stringent conditions for safety reasons
We are however imposing stringent conditions on the use of the new production location for the tests. For example, IDB must employ specialist workers to monitor the performance of the tests. They must also report any anomalies or unexpected events to the Authority for Nuclear Safety and Radiation Protection immediately. And put a stop to the testing at that time as well. IDB must also ensure that no radioactive substances end up in the environment. They will also update us on their progress at agreed times.
Would you like more information?
You can find out more about our decision to allow these tests in our exemption decision (in Dutch). We explain how we handle this type of ‘exemption request’ in our monitoring and intervention strategy (in Dutch).