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
It is important that people using OTC medicines understand the condition that they treat.
The information should be given in language that people will understand and can act upon. Medical terminology should be avoided, unless there is evidence from user testing that it is understood.
Where a product relieves symptoms, the language used must not imply that the product cures the condition. If a medical diagnosis is needed before self medication is undertaken, this should also appear on the packaging.
Relieves, soothes – may be used for all products which work by improving symptoms. These words indicate an improvement in symptoms.
Statements in relation to excipients in the formulation will not be acceptable as these are generally considered to be inert.
Stop as in “stop coughing” or “stop scratching” – should be used with caution. “Stop” may imply a product guarantee and can only be used when supported by the SmPC.
Statements preceded by can, to, may, helps, could, for– avoids implying that the product will work for 100% of the population, 100% of the time and may be used for all products.
Effective Relief – may be used for all products as the issue of a Marketing Authorisation is evidence that the product is effective.
- Remember that any non-statutory information must be less prominent than the statutory information.
- The indication must be in line with section 4.1 of the SPC
- Do not imply that the product cures the condition.