Home Human Medicines Regulatory Affairs Implementation harmonised productinformation (Class labelling)

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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.

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