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Labelling.PNG

Labelling

Labelling at a glance 

  • Manage labels for products in local markets

  • Track label updates in local markets and initiate activities, e.g. from risks

  • Maintain MedDRA CMQ/PT registry for auto-listedness ICSR option

Key features​

  • Manage label / data sheet for products and create versions according to local markets​

  • Initiate a change to a label, e.g. from Signals / Risks Modules. ​

  • Maintain safety information via CMQ/SMQ and dissolve into PT terms in the MedDRA dictionary. ​

  • Link to ICSRs for auto-Listedness calculation from label

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