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
Knowing when a product will work and how long it might work for is valuable information in ensuring safe use of a medicine and can aid compliance with dosage instructions.
Such information can help people understand if the product is working for them and enable them to make a decision about seeking professional advice for a diagnosis or a different, more appropriate, product.
Fast acting – may be used where the SmPC allow it. “Fast acting” statements may only be made for conditions where a fast onset of action is relevant to the clinical condition being treated, such as acute pain relief.
These statements may not be appropriate for chronic conditions or those not requiring immediate relief.
Gets to work in X minutes – is acceptable if the SmPC includes information regarding the onset of therapeutic action.
24 Hour action – dosage instructions to take the product once a day do not necessarily mean that a statement of 24 hour relief is acceptable. Clinical evidence must have been presented for inclusion in the SmPC to show that the clinical benefits of the product last for 24 hours.
Relieves pain for up to 12 hours – is acceptable if supported by the SmPC. This is preferable to more general statements such as “lasts for hours”.
Double or triple action – can only be used where a product has ingredients which work in two or three different ways. It cannot be used for products with ingredients with the same mode of action.
Long acting – where a medicine is formulated as a modified release preparation, the name of the medicine will reflect this and the term “long acting”, or similar, will appear within the name of the product.