Statements Relating to Side Effects and Safety

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

Within some therapeutic categories, there are differences in the side effect or interaction profiles and it helps people to choose the appropriate products if this is highlighted on the pack.

No medicine is absolutely safe. To the consumer, “safe” means that there are no side effects or interactions. Even if the SmPC has “no known side effects,” packaging information should not imply that the product is completely safe.

Non Drowsy – this statement may be used on products in a range where some contain ingredients which cause drowsiness, to help people identify or avoid products which may affect their driving. It may not be used to artificially distinguish between products where this is not an issue for the ingredients commonly available in a category. Any reference to drowsiness or sleepiness in the side effects section of the SmPC would preclude use of this statement.

Statements linking safety with natural ingredients – may not be made unless supported by the SmPC as described above.