Procedure for removal or addition of a patented indication for medicines for human use
December 6, 2021
The applicant or marketing authorisation holder for a generic medicine may decide not to include the patented indications or dosage forms in the marketing authorisation and not to mention them in the summary of product characteristics and package leaflet. Applicants/marketing authorisation holders must follow specific procedures to remove or reinsert the patented indication.
Source: FAMHP
Context
Following the judgment C-423/17 of the Court of Justice of 14 February 2019, the FAMHP has reviewed the procedure for the removal of certain patented data from the summary of product characteristics (SmPC) and the package leaflet.
The applicant or marketing authorisation holder can decide to adjust the SmPC and package leaflet themselves.
The removal of information from a patented indication and the inclusion of the standard phrase in the package leaflet are the responsibility of the applicant or marketing authorisation holder.