The Dutch Ministry of Health, Welfare and Sport (VWS) has decided that, effective immediately, pharmacies no longer need to request prior approval from the Health and Youth Care Inspectorate (IGJ) for the magistral preparation of radiopharmaceuticals based on a physician’s declaration. This change means that the preparation of radiopharmaceuticals now fully falls under the existing rules for magistral preparation of medicinal products.
The only condition set by VWS is that the preparation must remain within the quantities specified in the Letter from the Minister for Medical Care No. 569. Additionally, the preparation must comply with the field standards established by the Dutch Association of Hospital Pharmacists (NVZA), known as GMP-z. The IGJ will continue to monitor compliance based on a risk-based approach.
Impact on Daily Practice
For Pharmacies:
- No more prior approval required: This reduces administrative burden and speeds up the preparation process.
- Conditions still apply:
- Preparation must stay within the specified quantities.
- Compliance with GMP-z field standards remains mandatory.
- IGJ oversight: The IGJ will continue to supervise, but based on risk rather than prior approval.
For Holders of a Manufacturer’s License (not registered as a pharmacy):
- No exemption: They must still request prior approval from the IGJ for dispensing unregistered medicinal products based on a physician’s declaration.
- This falls under the so-called 3.17 procedure.