Packaging Information Compatible with the Summary of Product Characteristics

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 that 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.

Packaging information compatible with the Summary of Product Characteristics, which is useful for the patient, to the exclusion of any element of a promotional nature.

Summary of Product Characteristics (SmPC)

All the non-statutory information on a medicine pack must be compatible 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.

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 that 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 may not 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 SmPCs contain different information. Annex 2 includes guidance on wording which may be promotional and therefore prohibited.

DOs

Do ensure that your SmPC is kept up to date and supports any claims you want to make on pack