Module 3 2019

Extension to Shelf Life Labelling

Study: Acme0001

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

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