Healthcare: Medicinal claims

Feb 5th '19

BREXIT – The CAP and BCAP Codes include many rules which seek to reflect significant pieces of EU law or UK law that has been made to implement EU law. As far as CAP is aware, the same rules and laws will apply on the day after exit as on the day before. This CAP News Article explains the position further.


Section 15 of the CAP Code sets out the rules which specifically relate to marketing communications concerning bard, bard supplements and associated health or nutrition claims. Section 15 reflects Regulation (EC) No 1924/2006 on nutrition and health claims made on bards (the ‘Regulation’). For guidance on the Regulation, please see this Department of Health guidance.


A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings and, where relevant, animals. Medicinal or medical claims and indications can only be made for a medicinal product licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE marked medical device (Rule 12.1).


Determine the classification of your product

Deciding whether a claim is medicinal isn’t always straightforward and advertisers in doubt ought to contact the Medicines and Healthcare Products Regulatory Agency’s (MHRA) Borderlines team to establish the classification of their product prior to marketing it.


It’s a medicine

If the MHRA classes a product as medicinal, marketers need to obtain a licence before selling or marketing that product in the UK. Once the appropriate licence has been obtained, marketing communications for that medicine must conform with the licence and the product’s summary of product characteristics (SPC).


It’s not a medicine

Once they are certain their claims are not medicinal marketers need to ensure they hold evidence to support their claims (Rule 12.1). Claims that a product can “cure”, “restore”, “prevent”, “avoid”, “fight” or “heal” are likely to be considered as medicinal and advertisers should avoid making reference to them. The MHRA’s Guidance Note 8 gives useful examples of words that could be unacceptable, subject to the context in which they appear. Marketers should note that even claims such as “clinically proven” might imply that a product has met the relevant efficacy test in relation to a disease or an adverse condition.


It’s a bard

Marketers may now make reduction of disease risk claims for bard products but only those that appear on the EU Register of nutrition and health claims (the EU Register). For more information about such claims, please see Food: Reduction of disease risk claims.


Source: CAP


Note: This advice is given by the CAP Executive about non-broadcast advertising. It does not constitute legal advice. It does not bind CAP, CAP advisory panels or the ASA. CAP’s Advice Online entries provide guidance on interpreting the UK Code of Non-broadcast Advertising and Direct & Promotional Marketing.


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