CRED SMPC 2024

17/09/2024

Timelines

Draft Leaflet and Labels

Creation of mock ups & Specimens

PIL User Testing/ Human Factors

Internal Approval Process

MAA Submission Date

SmPC Creation

Publishing

The Organisation for Professionals in Regulatory Affairs

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Planning and Timings

A detailed plan with accurate timelines needs to be prepared and actively monitored with other functions:

• Internal process for review and approval (medical/clinical, safety, regulatory, CMC (Chemistry, Manufacturing and Control), quality, legal, marketing, commercial)

• Pack development, Artwork & Supply Chain

• Review by local operating companies/affiliates • Usability testing/Human Factors required? (4-6 weeks or longer)

• Working with a partner company will bring additional complexities

The Organisation for Professionals in Regulatory Affairs

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