when does the smpc need to be harmonised with the core safety profile (csp)?
The Core Safety Profile (CSP) encompasses the minimum
safety information for an active substance that must be
listed in the SmPC. The package leaflets will need to be modified
in accordance with the SPC changes. There are no harmonised package
leaflets derived from these CSPs.
The CSP is the minimum safety information for an active
substance the moment it is defined. Any texts drafted later must be
added to the SmPC in the interim.