MHRA: Medicines: packaging, labelling and patient information leaflets (20 April 2016 Version 2)

Summary

Guidance from the Medicines and Healthcare products Regulatory Agency (MHRA), explains how to package medicines for sale and what information you must provide to consumers and healthcare professionals.

Content

• Overview
• Labelling for medicines
• Safety features legislation
• Patient information leaflets (PILs)
• Warnings on labels and leaflets for medicines
• Braille on labelling and in PILs
• Child resistant packaging for medicines
• Submit information for full assessment
• Notification scheme registration
• Fees
• Make a submission or notification
• Complaints about labels, leaflets or packaging
• UK and European regulation