Labelling and the user package leaflet
The Traditional Herbal Medicines Registration Scheme requires that relevant products are accompanied by the necessary information for its safe use, such as safety warnings and contraindications.
Labelling and the user package leaflet should be in English and meet the requirements of Articles 54 to 65 of Directive 2001/83/EC, as amended by Directive 2004/27/EC. Compliance with the full requirements set out in these Articles is required.
Article 56a of Directive 2001/83/EC, as amended, requires certain information on the packaging and package leaflet to be in braille for the blind and partially sighted. European Commission guidance 'Guidance concerning the braille requirements for labelling and package leaflets' (external link) interprets the requirements for braille.
In addition to this, 2004/24/EC requires the labelling and user package leaflet of any relevant product to contain a statement to the effect that:
- this is a traditional herbal medicinal product for use in specified indication(s) exclusively based upon long-standing use
- the user should consult a doctor or a qualified health care practitioner if the symptoms persist during the use of the medicinal product or if adverse effects not mentioned in the package leaflet occur.
The following guidance may be of help to you when considering the labelling and user label:
- MHRA Guidance Note 25: 'Best Practice Guidance on the Labelling and Packaging of Medicines'
- 'A guideline on the readability of the label and package leaflet of medicinal products for human use'. Brussels: European Commission, 2009. (external link)
- 'Excipients in the label and package leaflet of medicinal products for human use'. Brussels: European Commission, 2005. (external link)
- 'A Guideline on Summary of Product Characteristics'. Brussels: European Commission. 2005. (external link)
Further information is available in the 'Labels, patient information and packaging for medicines' section.
Permitted indications
Registered products will have indications exclusively appropriate to traditional herbal medicinal products which, due to their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring treatment.
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More information on permitted indications
Advertising
Advertising includes any activity designed to promote the prescription, supply, sale or consumption of medicinal products. Advertising can take various forms and include posters, advertisements in newspapers and magazines, consumer leaflets, internet websites, direct mailings, radio and television adverts, cinema commercials and point-of-sale materials.
Advertising and promotion of traditional herbal medicines that fall within the THMRS must meet the requirements of Articles 86 to 99 of Directive 2001/83/EC, as amended. In addition to these requirements, Directive 2004/24/EC requires any advertisement for a medicinal product registered under the scheme to contain the following statement: 'Traditional herbal medicinal product for use in specified indication(s) exclusively based upon long-standing use'.
All advertising must comply with the particulars set out in the authorised Summary of Product Characteristics (SPC) for the product, must encourage rational use of the product by presenting it objectively and without exaggerating its properties and must not be misleading.
Advertisements to the public must include the name of the product, the common name of the product where the product contains only one active ingredient, at least one indication for use (information necessary for correct use of the product) and an invitation to 'Always read the label' or equivalent.
Further information about the legal requirements for medicines advertising can be found in MHRA Guidance Note 23, 'Advertising and Promotion of Medicines in the UK' - The Blue Guide which explains the regulations and provides clarification on the Agency's interpretation of them.
Self-regulation in the UK
The legal framework in the UK is supported by other regulatory and self-regulatory systems set up by industry and other authorities. These include Codes of Practice covering the promotion of prescription and over-the-counter (OTC) medicines. The following bodies are involved in regulating medicines advertising through Codes of Practice and complaints procedures:
- The Proprietary Association of Great Britain
- The Prescription Medicines Code of Practice Authority of the Association of the British Pharmaceutical Industry
- The Committee of Advertising Practice.
- The Advertising Standards Authority.
- The Office of Communications (Ofcom).
- Health Food Manufacturers' Association
Additional information including a list of the applicable regulations and guidance issued with information on how we regulate advertising for medicines and reports of recent cases investigated can be found the 'Advertising of medicines' section.
