In 2023, Isala Hospital (Zwolle, NL) became the first Dutch hospital to submit a registration for an in-house compounded medicinal product: prefilled ephedrine syringes. This was a pioneering step aimed at safeguarding both hospital compounding and the availability of essential medicines.
Obtaining and maintaining a marketing authorisation requires expertise far beyond pharmaceutical compounding, including regulatory affairs and lifecycle management.
While Isala’s application has not yet resulted in a registration, recently another entity -a collaboration between a hospital pharmacy and a pharmaceutical company- has now apparently become the first to obtain a registration for hospital-compounded ephedrine products, filled in prefilled syringes and ampoules.
This development demonstrates that hospital-compounded products can successfully make the transition to licensed medicines, whether driven by a hospital pharmacy alone or through a dedicated legal entity.
If you are a hospital(pharmacy) wanting to explore the possibilities of registering hospital compounded products, please feel free to contact us at info@starodub.nl
