CRED SMPC 2024

17/09/2024

Implementation

⚫ Process for implementation of changes should be defined in company procedures for labelling management

o Categorise implementation timelines from urgent safety (immediate), planned safety changes, planned administrative label change.

o May include process for updating SmPC and Package Leaflet on company websites and external databases.

o May include process for updating the abbreviated Product Information used for promotional materials.

⚫ Timings for implementation may differ – planning is key

o Urgent safety changes may need immediate action, no further market release of existing stock, immediate update to abbreviated Product Information, immediate update of databases, possible DHCP letter.

o Some markets may insist on immediate (no grace period) implementation for all or certain changes (e.g. MAH transfers). Upfront planning key to ensure stock build and avoid market stock-out.

The Organisation for Professionals in Regulatory Affairs

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Implementation – cont.

Can we combine

How urgent is it? When is the next batch?

⚫ Optimising the timing of implementation will reduce wastage and associated costs o Cross functional Labelling Implementation Team recommended for planning upcoming changes impacting artwork and artwork implementations in progress.

with other changes?

o Communication of changes is key for changes to the abbreviated PI for promotional materials.

Does this impact other products?

CONSIDER “Batching” changes is more efficient but works best when you can exhaust component stocks – i.e. frequent production runs. However, timing is critical as implementation countdown starts from first approval date.

The Organisation for Professionals in Regulatory Affairs

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