OTC medicine packaging

The primary purpose of medicines labelling and packaging is the clear unambiguous identification of the medicine and the conditions for its safe use. This is particularly important for over-the-counter (OTC) medicines which are designed for consumers to select and use without medical intervention for a range of conditions.

Good patient information is essential to ensure people can choose and use medicines safely and high quality patient information is part of the wider risk minimisation measures which are considered as part of the reclassification of a medicine from prescription supply to OTC.

Regulating medicine packaging and submitting changes

The labelling components of medicines are controlled by product information contained in the Summary of Product Characteristics (SmPC), and specific legislative requirements set out in national legislation (Human Medicines Regulations 2012, as amended) and in European directives where applicable.

It is the licence holder’s responsibility to ensure the SmPC is updated in line with current medical knowledge and safety information whenever this changes. The SmPC is the blueprint for packaging information and each piece of information on the label must be supported by information in the SmPC.

In the UK, mock-ups of labelling components (e.g. labels, cartons, blisters) are submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA). The first approval of full colour mock-ups for labelling and Patient Information Leaflets (PILs) will usually be when a marketing authorisation is granted. Following this, most changes are subject to self-certification and subsequent notification to MHRA when these are not connected with changes to the SmPC. However, there are occasions where changes require submission for full assessment by the MHRA Product Information Quality Unit (PIQU), and you can find more information about this in MHRA’s guidance on submitting changes to labelling and patient information leaflets.

Our work on medicine packaging

P3Ex submissions

We offer pre-vetting of changes to pack design and layout for medicines as part of MHRA’s P3 expedited (P3Ex) assessment procedure. Where changes have been pre-approved, the application should be assessed within 30 days of the application being deemed valid by MHRA, rather than the usual 90-day period for direct submissions. This service is free for medicines within membership of PAGB. Fees apply for products not in PAGB membership, you can find out more by emailing packdesign@pagb.co.uk.

We monitor P3Ex approval rates and regularly meet with the MHRA PIQU to improve consistency and help companies achieve right first-time submissions.

We run twice per year labelling horizon scanning to understand our members’ plans and help us allocate resources for big rebranding projects.

We have guidance on the PAGB pre-approval scheme, including how to submit artwork to us for review, which can be found here.

Packaging code, guidance and workshops

Our Packaging Code for Medicines sets out the requirements for packaging and labelling for OTC medicines, covering both statutory and non-statutory information. It was developed with input from member companies and MHRA to encourage best practice in medicines labelling, expanding on existing guidance (including MHRA’s best practice in the labelling and packaging of medicines guidance) and providing practical advice.

Our notification scheme guidance provides a positive list of acceptable changes to demonstrate the circumstances under which changes to the labelling and PIL can be subject to self-certification by the marketing authorisation holder, requiring only a notification to be made to MHRA. You can read our guidance here.

We regularly run a workshop on OTC medicines packaging which covers the statutory and non-statutory information required and allowed on OTC medicines packaging and reflects the latest MHRA guidance. The workshop is delivered by members of our regulatory team and features presentations from, and a Q&A with, guests from the MHRA PIQU. You can find out more details and book your place on our next course here.

Bespoke advice and intelligence

We have a dedicated mailbox for artwork reviews and advice – packdesign@pagb.co.uk. You can also arrange a meeting with our regulatory team via our online booking portal for advice and guidance on pack design for medicines.

We share intelligence on medicine packaging with our members, including via our regulatory intelligence newsletter which you can subscribe to here.

Pack design working group

We have a dedicated working group – the PAGB Pack Design Working Group – which is overseen by PAGB’s Regulatory Affairs Group.

The pack design group provides expert regulatory insight and technical information to PAGB to assist in the creation of regulatory policy and projects relating to medicine packaging. The group supports PAGB’s objective for medicine packaging to be self-regulated in future.

If you are interested in joining or learning more about this group, please email regulatory@pagb.co.uk.

Electronic Patient Information (ePI)

PAGB is leading on a cross-industry initiative with the British Generic Manufacturers Association (BGMA) and the Association of the British Pharmaceutical Industry (ABPI) called the UK Electronic Patient Information (ePI) Task Force. The task force is made up of industry associations, medicines manufacturing companies, NHS organisations and MHRA.

The purpose of this task force is to facilitate a move to user-centred, digital-first medicines information for patients that is inclusive and accessible for all, better for patients and the environment.

We also input into ePI discussions and work at EU level via the Association of the European Self-Care Industry (AESGP).

OTC medicine packaging