A guideline to harmonise the Summary of Product Characteristics (SmPC) and the Patient Leaflet (PL) of paracetamol containing medicines for oral use is recently published on the website of the Belgian Federal Agency for Medicines and Health Products (FAMHP).The guideline was created based on available literature, recommandations of the European Pharmacovigilance Risk Assessment Committee (PRAC) and recently approved medicines containing paracetamol after an European procedure.

Marketing Authorization Holders (MAH’s) are requested to check if the safety information published in the guideline already is stated in the SmPC and PL of paracetamol containing medicine for oral use approved for the Belgian market.
Missing safety information of the guideline can be added on the SmPC and/or PL through a Type IB variation. It is also recommanded that a pipet is used for dosing of liquid paracetamol containing medicines for oral use. A separate Type IA variation can be used for a pipet containing a CE marking; A Type IB variation is necessary for a pipet without CE marking.

The published guideline can be consulted here

Share This