OTC medicine packaging


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

young woman consumer choosing medicines from shelf

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). 

Latest regulatory intelligence on ePI