CRED SMPC 2024

17/09/2024

Triggers for Labelling Changes

Company

Health Authority

Technical

New product introduction

PRAC/Safety

Security features / serialisation

CCDS driven update to regulated content

New guidance / rules

Format / layout

Template update

Line changes

CMC changes (shelf life, storage)

Harmonisation

Branding updates

Administrative changes (addresses, etc.)

The Organisation for Professionals in Regulatory Affairs

5

What is Implementation?

⚫ Making information available to patients/healthcare professionals, via

o Inclusion in finished product – leaflets, cartons, blisters, Instructions for Use, etc.

o Electronic access to approved product information in national/regional repositories, e.g. electronic Medicines Compendium (emc), Fass.se.

o Implementation of updates to the abbreviated product information (API) for promotional use.

⚫ Ensuring that implementation timelines are met

o Implementation change control (QMS/AMS).

o Implementation definition.

o Labelling Implementation Team – plan upcoming and monitor work in progress.

The Organisation for Professionals in Regulatory Affairs

6