The FAMHP has updated the guidelines related to paracetamol for marketing authorisation applicants and holders. Stakeholders are invited to comment on these changes.
In order to provide patients and healthcare professionals with up-to-date information on paracetamol-containing medicinal products (oral and rectal forms), the Federal Agency for Medicines and Health Products (FAMHP) has updated the guidelines for marketing authorisation (MA) applicants and holders.
These guidelines apply in priority to medicinal products covered by a national procedure. Although they are not binding within the framework of the Mutual Recognition Procedure (MRP) and the Decentralised Procedure (DCP), they nevertheless constitute a basis for discussion used by the FAMHP within the framework of the European procedures.
The new version is open for public consultation (FR - NL).
Practical information
The consultation period begins on 19 May 2026 and ends on 19 June 2026.
During this period, stakeholders, and in particular MA holders/applicants, may submit their comments on this new version.
Comments may be sent to vig@fagg-afmps.be - in the form of a Word document with track changes, based on the available files (FR - NL).