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Good pack design aids assimilation of the key information necessary for the safe selection and use of the medicine. It involves the use of colour, typography, graphic style, imagery, illustration and photography, and an understanding of how people choose and use products.
For the consumer, the pack has to spell out what the product is for, who it is for and provide the information about all the attributes which are important to ensure it can be chosen and used safely and effectively.
As more new products are introduced under existing brand names, differentiation between products in a range is critical for safe and effective use. Good design will ensure that different products are adequately differentiated so that there is no confusion for consumers. The best design will build in elements to help differentiation from the outset.
No statement or image should be included on packs unless the relevant SmPC supports it. This is particularly important in designing product ranges where the different products may have been authorised over a period of years and have different SmPCs. It may be necessary to amend the SmPCs to ensure that there is consistency in the final pack designs.
The greater the risk which might arise from use of the wrong product, the greater the differentiation must be. Look at product ranges as a whole and review the products for risk as well as benefit – note the different indications, active ingredients, side effects and target groups. Ensure that these are highlighted appropriately in elements of the pack design.
Risk may be interpreted differently if the products are Pharmacy Sale (P) or General Sale (GSL). Those on general sale will not have health professional advice available at point of sale and will need greater differentiation since it cannot be assumed that people will purchase only one class of product.
Use colour differences where appropriate to differentiate products – but do not rely on colour as the sole method of distinguishing between active ingredients or between important safety attributes.
Avoid the use of iconography which detracts from clear understanding of the indications and use of the medicine. Look at the design as a whole and use images which help people to navigate and identify the products.
While computer generated images will be the main way to submit pack designs for approval, pack mock-ups may be requested in some cases to allow the impact of colours and fonts to be evaluated. This can be important in the case of reflective backgrounds or where the differentiation between important elements relies on shades of the same colour.
Research can help clarify whether design elements communicate clearly. While it is not essential to submit research supporting the pack design, research can assist in the approval and evaluation of packs under this Code of Practice, particularly where differences of approach or opinion arise in the process. Generic market research with focus groups, for example, is unlikely to be sufficiently robust. However, formal targeted consultation with selected consumers and patient groups may be acceptable. Companies are advised to submit the research protocol to the MHRA for review of the study methodology.
Therapeutic category guidance may evolve. Where evidence exists that a key element of information is important in helping consumers identify products within a range or across a category, guidance will be developed to promote good practice and consistency in designing this information into the pack. For analgesics, for example, it is important that patients are made aware from the front of the pack exactly which active substance is present within the formulation and this needs to be given due prominence