Article 62 permits the inclusion on the label of information which is compatible with the SmPC and which is useful for the patient, provided it is not promotional.
Packaging information compatible with the SmPC, which is useful for the patient, to the exclusion of any element of a promotional nature
Article 62 of Council Directive 2001/83/EC permits the inclusion on the label of information which is compatible with the SmPC and which is useful for the patient, provided it is not promotional. It is acceptable to include information that describes how the product works or which highlights a particular attribute of the product, provided it is compatible with the SmPC. The fact that the same phrase may appear in advertising or public relations material does not mean that it cannot be included on the packs, but the context must be carefully considered. Information included on one Marketing Authorisation holder’s labelling may not be appropriate for another company’s label where the SmPC contain different information. Annex 2 includes guidance on wording which may be promotional and therefore prohibited.
All the non-statutory information on a medicine pack must comply with the SmPC and must not include elements which are promotional in nature.
Non-statutory information must be subordinate in placement and prominence to the statutory information
While the critical health information panel must be the primary place for people to locate and understand the information they need to use the product safely, the rest of the pack is also important.
Innovative pack design across manufacturers’ product ranges should ensure accurate identification of the individual products and differentiate between products in a range. Where similarities exist between product names, pack design should allow differences to be easily discernible. This will form part of any safety assessment carried out by MHRA staff to determine for example the suitability of a proposed name.
Pictures of children – pictures of children on a pack can help highlight medicines which are suitable for children. Where children are used, they should appear to be in the age range that the medicine is intended for. It is not sufficient to establish that the child’s actual age is in the target group.
Pictures of parts of the body – pictures of parts of the body can help consumers understand what a product is for and how it works. They can also help distinguish between products in a range.
Pictures of tablets – showing pictures of tablets or capsules on packs helps consumers identify their shape, and whether they are soluble, effervescent or chewable. Where a picture is used on a pack, the illustration must be the same as the tablet inside and reflect the actual size of the dosage form. The number of tablets shown must be considered so as not to mislead about the dose. For example, where the OTC dose of the active ingredient is limited, the number of tablets shown must not depict a quantity of ingredient which is a prescription only dose.
Pictures of leaves and fruit – images of leaves or fruit are only acceptable where natural extracts are used in the formulation. The use of artificial flavours will preclude the use of these devices on labelling.
- Remember that any non-statutory information must be less prominent than the statutory information.
- Symbols and pictograms can be useful provided the meaning of the symbol is clear and the size of the graphic makes it easily legible.