Hospitals must, according to the Royal Decree of 13 September 2023, issue a tender for biological and biosimilar medicines within nine months after a first biosimilar pharmaceutical speciality, authorized in accordance with the law of March 25, 1964 on medicinal products, is registered on the list of reimbursable pharmaceutical specialities and is available.  

As the regulations became stricter in 2023, the NIHDI has put a FAQ with the most frequently asked questions online. The FAQ covers topics such as: 

  • The deadline of nine months and deviations from this timeline. 
  • The scope of the Royal Decree. 
  • Communication and communication frequency from NIHDI.  
  • Characteristics which can be used as award/selection criteria. 

Source: Biosimilaire_geneesmiddelen (

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