Permission for GE Healthcare in Leiderdorp for new radiopharmaceuticals pharmacy

GE Healthcare, a company based in Leiderdorp on the Simon Smitweg 3A, has been given permission to open a new radiopharmaceuticals pharmacy. At this pharmacy, GE Healthcare will be producing radiopharmaceutical products: medicinal products that contain ionising radiation. Those who wish to object to the licence have until 1 May 2024 to lodge their objection.

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Image: ©ANP
Aerial photo of Alrijne hospital in Leiderdorp where the new pharmacy for radiopharmaceutical products is being built

Radiopharmaceuticals: medication to detect cancer

Physicians in hospitals use radiopharmaceutical products to detect cancer. We indicate in the licence how GE Healthcare should ensure safe handling of the radioactive materials present in the medicinal products.

Leiderdorp: location for the processing and distribution of radiopharmaceutical products

GE Healthcare’s headquarters are located in Eindhoven. That is where the company produces radiopharmaceutical products for Dutch hospitals. Part of the production of the medicinal products currently taking place in Eindhoven will be moving to the GE Healthcare location in Leiderdorp. From there, they will be distributed to the hospitals. Temporary storage will take place at the Leiderdorp site. Some radiopharmaceutical products are not yet ready for use when they arrive from Eindhoven. They are then further processed in one of the laboratories in Leiderdorp.

What is GE Healthcare receiving permission for?

GE Healthcare was required to demonstrate that they can safely handle the radioactive materials needed to produce these medicinal products in Leiderdorp. This includes processing radioactive materials in the three laboratories on site. They also have to demonstrate how the temporary storage meets the safety requirements, for instance fire safety. The licence also states how they should deal with radioactive waste.

In these activities involving radioactive materials, ionising radiation can be released. To be granted a licence, GE Healthcare had to demonstrate how it makes sure that the level of radiation remains within the statutory limits. These limits ensure that the use of the radioactive materials is safe for workers and the environment, for example.

GE Healthcare is also using sealed radioactive sources, among other things for taking measurements. ‘Sealed’ means that the source is attached to a protective material, preventing dispersal to the environment. The licence states how they should deal with this, also in terms of storage.

No responses to the draft licence

From 10 January to 21 February 2023, everyone had the opportunity to respond to the draft licence. No objections were submitted during this time.

Appeals may be submitted up to and including 1 May 2024

If you disagree with this decision, you can lodge an appeal. You can do so if you are a stakeholder, which means our decision to grant this licence affects you directly. You can also lodge an appeal if you previously submitted a response (objection). Or if you cannot reasonably be blamed for not submitting an objection.

If you lodge an appeal, you can also apply for injunctive relief. This ensures that the licence does not enter effect until after review of your appeal.

You then submit your notice of appeal or request to the Administrative Jurisdiction Division of the Council of State. There are two ways to do this:

  1. Online: if you are a private citizen, you can log in with your DigiD to the digital service desk of the Council of State and submit your notice of appeal there.
  2. By post: send your notice of appeal to the Administrative Jurisdiction Division, Council of State, P.O. Box 20019, 2500 EA The Hague.

Would you like to know more?

Please read the notification in the Government Gazette (in Dutch). For more information about radioactive medication, go to the section on medicinal isotopes on this website.