Legislation Special – the legal position for Herbals, Botanicals and Homeopathy

Q: LET’S START WITH HOMEOPATHY. WHY DO WE HAVE A SMALLER RANGE AND WHY ARE SOME NO LONGER TERMED ‘MEDICINES’?

In 1971 homeopathy manufacturers were required to obtain ‘Product Licences of Right’ (PLRs) under the UK Medicines Act 1968 and indications for use were permitted.

This continued happily until the European Homeopathic Medicines Directive of 1992 set up a product registration scheme (HR) based on safety and quality but not efficacy, which does not allow indications. In 2006, the UK set up a National Rules (NR) scheme which allows qualifying products to have NR indications – currently there are 11 NRs, the latest being Nelsons Sulphur 30c.

Most manufacturers clung on to their PLRs for dear life but lately it has become difficult and more expensive to maintain them and the MHRA has been pressurising them to convert to NRs and/or drop their PLRs. A recent example is the Bach Flower Remedies which no longer have PLRs.

Q: WHAT’S THE POSITION FOR A RETAILER SELLING LOOSE, DRIED HERBS?

Loose medicinal herbs are not subject to medicines licensing if they are dispensed from bulk (i.e. not pre-packed for selfselection).

Direct advice to customers is best avoided because then you are in effect making a health claim for a product that doesn’t have a licence. However, there’s no reason why you can’t encourage the customer to ask for the appropriate herb by ‘oblique’ recommendation: “I’ve heard it said that…”. No one has been taken to task for giving direct advice but we should all be wary of the retail police in this respect!

Continue to read our Legislation Q&A with Penny Viner here.