Pack design Code
Over-the-counter medicines are designed for the public to chose and use without medical intervention for a range of illnesses. Good consumer information is essential to ensure that people can safely self medicate and the most important place for this information is with the product itself.
PAGB has developed the Code of Practice for Pack Design for Over-the-counter Medicines to encourage best practice in medicines labelling and provide practical advice to manufacturers designing and amending the packaging of OTC medicines.
The Code has been developed with input from the Medicines and Healthcare products Regulatory Agency (MHRA).
Member companies can submit non-statutory pack design changes to PAGB for
pre-approval in compliance with the Code, and then consequent expedited approval from MHRA. PAGB can also provide advice on changes to the statutory information.
The Code is now online at: www.pagbpackagingcode.com
The website explains the processes to follow when artwork is being submitted to PAGB for approval. MHRA has also published a downloadable document:
Guidance for applicants following pre-approval by PAGB
Other useful documents include:
- MHRA’s Best practice guidance on labelling and packaging of medicines
- Guidance on changes to labelling and patient information leaflets for self-certification
- Guidance on changes to labelling and patient information leaflets for self-certification – compliance with Article 56(a) - Inclusion of Braille on labelling
- PAGB Briefing Note: The PAGB Code of Practice for Pack Design –
How does it work in practice?
For further information please contact the PAGB Regulatory team on 020 7242 8331.