9/10 May 2023
The European Medicines Agency (EMA) has published a "Reflection paper on collecting and reporting information on off-label use in pharmacovigilance" for public consultation.
The document contains suggestions about the collection and reporting of information concerning off-label use of medicinal products. In particular, it deals with the collection and reporting of information on off-label use not associated with suspected adverse reactions on the medicinal product.
The following two scenarios can be distinguished:
A. Off-label use of a medicinal product, which results in harm to a patient i.e. the occurrence of one or more suspected adverse reactions
with the obligations of:
B. Off-label use of a medicinal product, which does not result in harm to a patient i.e. without the occurrence of one or more suspected adverse reactions
with the obligation of:
Comments can be submitted to the EMA until July 29, 2016.
Further information can be found in the draft of the "Reflection paper on collecting and reporting information on off-label use in pharmacovigilance".