Statements Relating to Particular Groups of the Population

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

The legal provisions within Article 62 of Council Directive 2001/83/EC (amended) permit the use of images, pictograms and other graphics designed to clarify certain information.

While OTC medicines have a good safety profile, they are not suitable for everyone.

Pregnant women in particular should be advised not to take medicines without professional advice. Other groups of the population, such as people with diabetes and parents of children, find it useful if the label includes information which is relevant to them which helps them and choose the appropriate product.

Where such statements are made on pack, evidence must be provided to support the statements.

Sugar-Free – this statement may be used in relation to oral liquid medicines, lozenges, pastilles, chewable tablets and gums which do not contain fructose, glucose or sucrose. Medicines containing hydrogenated glucose syrup, mannitol, maltitol, sorbitol or xylitol may also be referred to as sugar-free as there is evidence that these excipients do not cause dental caries. Where the product contains other sugars, such as lactose, this statement may not be included as the information may be misleading.

Suitable for people with diabetes – where this statement is used, the guidelines issued by Diabetes UK must be adhered to. It is not acceptable to use it to describe products that are sucrose free but contain other sugars such as lactose. Some sweeteners also have a calorific value. The statement can be included within the critical health information panel.

Gluten-Free – where information is available from the SmPC that the product can be deemed gluten-free, a statement to this effect can be included within the critical health information panel. No graphic or promotional symbols may be included anywhere on the pack, but particularly not on the front of pack.

Can be used in pregnancy – this statement may only be included within the critical health information where a product is specifically indicated for use in the pregnant population in section 4.1 of the SmPC. Dosage information must be included in section 4.2 of the SmPC and a supporting statement must also appear in section 4.6 of the SmPC. Front of pack statements in relation to use in pregnancy cannot be included.

Symbols – symbols can be included to support the statutory information. The meaning of symbols should be clear and supported where necessary by user consultation. Logos and symbols relating to particular trade bodies or patient organisations are not acceptable. A list of acceptable symbols will be developed as experience with the Code of Practice is gained.

SmPCs

Sections of the SPC relevant to this section of the Code of Practice are:

Section 4.1

Therapeutic indications

SmPCs

Pregnancy and lactation

Examples of wording found in this section:

“The medicinal product may be used during pregnancy and lactation.”