Categories: OTC medicines
Access: open access
PAGB has developed this Code of Practice, with input from member companies and the MHRA, to support companies in remaining compliant with medicines labelling regulation.
Access to over-the-counter (OTC) medicines – medicinal products available to select and buy from pharmacies and other retail outlets without a prescription – is a key factor in enabling people to self care for self-treatable conditions. The inclusion of high-quality patient information is one of the wider risk minimisation measures which are considered as part of the reclassification of medicines from prescription only to Pharmacy (P) medicines and General Sales List (GSL).
This Code has been developed to expand on existing guidance and provide practical advice to manufacturers designing and amending the packaging of OTC medicines. It draws from the Best Practice Guidance on the Labelling and Packaging of Medicines developed in the UK and issued by the MHRA. This Code also refers to the Report of the Committee on Safety of Medicines Working Group on Patient Information, ‘Always Read the Leaflet – Getting the best information with every medicine’, and the EMA Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use.
PAGB’s Packaging Code for Medicines covers the statutory and non-statutory information required and allowed on OTC medicines packaging. It also provides guidance on the use of promotional information, including what you cannot say, and on design elements such as typography, layout and graphics.
This Code sets out legislative requirements and additional guidance that are needed to support pack design applications.
PAGB’s Packaging Code for Medicines has been developed with input from the MHRA and reflects the MHRA’s interpretation of legislation and current policy. It is not, in itself, a legal requirement; however, it is a key element of the self-regulation of OTC medicines – enabling continued access to self care products without a prescription.
It is member companies’ responsibility to ensure that all applicable legal requirements and all requirements of the relevant self-regulatory Codes of Practice are complied with. We recommended that companies provide their regulatory, brand and marketing teams, and relevant suppliers, with copies of the PAGB Packaging Code and nominate someone to be responsible for ensuring compliance.
All PAGB member companies are required to adhere to this Code and can optionally submit packs for checking before submission to the MHRA.
PAGB’s pre-approval scheme for OTC medicines covers changes to pack design and layout, also known and referred to as P3Ex changes – see the flow diagram on page 7 of the Code for a guide to the different routes of approval for medicines packaging.
Find out more about PAGB’s P3Ex pack review service – this service is available to members free of charge, and to non-members for a fee.
PAGB runs specialist OTC medicines workshops to support members and non-members to understand what they need to consider when advertising and promoting OTC medicines and how to apply the principles of the PAGB Codes.
For regulatory support and queries about OTC medicines, including packaging, contact firstname.lastname@example.org.
Download PAGB’s Packaging Code for Medicines
PAGB’s Codes of Advertising Practice, guidelines and additional guidance for OTC medicines, self care medical devices and food supplements are available here. Log in to the members’ area to access the full range of guidance. For more information, contact email@example.com.
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For more information about this guidance, please contact firstname.lastname@example.org