Module 3 Presentations

07/05/2024

Labelling Requirements

Exceptions for different

Study: Acme0001

levels of labelling

21 NewIMP tablets 100 mg or placebo Take one tablet each morning Packing Batch: AAAA Expiry: 03.2022 Investigator: ________________ Patient Code: ________________

Except if IRT controlled (CTD)

CTR Expiry Date must be on all levels

Kit ID: XXXXXXXX Store below 30°C For Oral Use For Clinical Trial Use Only Keep Out of Reach of Children Acme drugs ltd, An address, Somewhere, +44 1234 5678910

The Organisation for Professionals in Regulatory Affairs

15

Extension to Shelf- Life Labelling

Following Reg CMC Change Control to update stability information - SA? - NSA? - No submission? Impact of Clinical Trial Regulation to ESL

Study: Acme0001

21 NewIMP tablets 100 mg or placebo Take one tablet each morning Packing Batch: AAAA Expiry: 03.2022 Investigator: ________________ Patient Code: ________________ ---------- 03.2023 AAAA

Kit ID: XXXXXXXX Store below 30°C For Oral Use For Clinical Trial Use Only Keep Out of Reach of Children Acme drugs ltd, An address, Somewhere, +44 1234 5678910

The Organisation for Professionals in Regulatory Affairs

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