Formulation Statements

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

While the most important ingredient in any medicine is the active ingredient, other aspects of the formulation are important. People who have difficulty swallowing tablets seek soluble, effervescent or capsule shaped tablets or suppositories.

In established products, active ingredients or excipients change from time to time as new ingredients replace older, less safe or less efficacious ones. It is acceptable to highlight such changes to alert people who are already using the products to some new aspects of it.

It can also be helpful to draw attention to higher dose products and to those products which are available only in pharmacies where professional assistance can be obtained provided these do not suggest superiority of the product or contain elements which are considered to be promotional.

Unique Formulation – this statement may be included where the product in question is the only licensed medicine with that particular qualitative formulation. Should another medicine be authorised with the same ingredients this statement will need to be removed.

New – this statement may be used where appropriate for a period of one year from launch of the new product. It can be used to identify a change in the formulation of an existing product or to identify a new product (i.e. not new pack size or packaging design) within a range. The relevance of the word “new” must be obvious from the context.

New Flavour – this statement may be used for a period of one year from launch of the new flavour. It can be used to draw attention to a change in the formulation or the introduction of a new product with a different flavour.

Pharmacy Only Formulation – this may be used if the product contains an ingredient which is restricted to pharmacy sale. It may not be used to describe a pack size that is restricted to pharmacy sale.

Maximum Strength – may be used where a product is part of a range to designate the higher strength product or where a product contains the maximum level of an active ingredient which is permitted in an OTC product. It cannot be used when there is only one strength of an ingredient available.

Peppermint (or other) Flavour – this statement can be used to highlight the taste of a product. It is particularly useful for products such as throat lozenges and gum, which stay in the mouth for a time. Statements such as cooling mint are promotional in style and not allowed as the statement is in relation to an excipient within the formulation.

Natural – this statement may only be used where all of the ingredients are natural. If only some of the ingredients are natural then the term is not permitted. The term “natural action” can be used for products for constipation which work by stimulating peristalsis to distinguish them from irritant or bulk forming laxatives.

Acts naturally, works naturally, natural relief for congestion, relieves symptoms naturally – is only acceptable for products which have a natural mode of action, i.e. an action which mimics a physiological mechanism of the body. For example, the term “natural action” has been used for products for constipation which work by stimulating peristalsis.

Herbal – may not be included unless the active ingredients are 100% herbal. It is not necessary for the excipients to be of plant origin.

Excipient Statements – information in relation to the action of excipients within the formulation may not be included as non-statutory information as excipients are generally considered to be inert.

Factual statements about excipients in the formulation may be acceptable where these are not deemed to be promotional, e.g. This product contains Xmg of Vitamin C (refer to MAIL 150).

Statements such as “pleasant” are deemed promotional and prohibited by Article 62 of Council Directive 2001/883/EC.

DOs

  • Remember that any non-statutory information must be less prominent than the statutory information.

DONTs

  • “New pack size” is deemed promotional and therefore not acceptable on pack.
  • “Prescription strength” is considered to be promotional and therefore not acceptable on pack.
  • “Contains natural colours” is considered to be promotional and therefore not acceptable on pack.

SmPCs

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

“New” is used from 1 year from launch to the market so this is something companies would need to keep track of.

Natural and flavour statements it would need to be supported by Section 6.1 of the SPC.