Module 3 2019

Labelling Requirements

Study: Acme0001

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

Exceptions for different

Except if IRT controlled

levels of labelling

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