Herbal Medicines within Modern Society: The Future for UK Suppliers

Herbal Medicines what are they?

Herbal medicines use plant-based materials for the treatment of specific symptoms or diseases. These herbs and herbal formulations have been used for centuries within different cultures e.g. India and China.
(Wikipedia Definition)

Current Trends and Regulations

The public is increasingly well informed about their health and the options available to them to prevent and/or treat disease. This knowledge combined with the trend of organics and health foods, means that herbal medicines have become increasingly popular. Traditional herbs and herbal formulations used in India and China are making their way into Europe increasing the range available. It is therefore, even more important that people are aware that herbal medicines have a physiological effect on the body and should be used with care. Regulation of herbal remedies within the UK has been fairly relaxed but particular safety concerns have come to light, for example, the interaction of St John's Wort with some conventional medicines.

Herbal medicines can reach the market via the following three routes:

• Unlicensed herbal remedies
• Registered traditional herbal medicines
• Licensed herbal medicines

a) Unlicensed herbal remedies

Most herbal remedies currently for sale within the UK are unlicensed as they are exempt from holding a product licence (marketing authorisation). (Exemption outlined in Section 12 of the Medicines Act 1968).

b) Registered traditional herbal medicines

On 30th October 2005 the "Traditional Herbal Medicines Registration Scheme" was introduced in the UK. It is also a requirement of the European Directive on Traditional Herbal Medicinal Products (2004/24/EC). This simplified registration scheme requires remedies to meet standards of safety and quality but not necessarily the same level of efficacy as for a fully licensed product.

c) Licensed herbal medicines

Approximately 500 herbal medicines have a product licence (marketing authorisation). In order to obtain a product licence, a company has to demonstrate that their herbal medicine meets certain standards of safety, quality and efficacy. Licensed herbal medicines can be readily identified by a unique nine number Product Licence number on the product container or packaging with the prefix "PL".

The Future

New unlicensed herbal remedies can no longer be brought into the UK. Herbal Medicines must have either a Traditional Herbal Registration (THR) or a Product Licence (PL). There is, however, one exception to this and that's where the herbal remedy can meet both of the following requirements:

1) it is legally on the UK market as an unlicensed herbal remedy in accordance with s12(2) of the Medicines Act 1968 and
2) was also legally on the UK market under s12(2) at 30 April 2004

Unlicensed herbal remedies which meet these two requirements, will qualify for transitional protection and, therefore, can continue to be marketed as an unlicensed herbal remedy until 30 April 2011 provided it continues to comply with the requirements of s12(2).²

After 30 April 2011 only THR or PL herbal remedies will be permitted. The Medicines and Healthcare products Regulatory Agency (MHRA) will insist that unlicensed herbal remedies are withdrawn unless they have met the THR or PL requirements.

The MHRA has already begun to exercise their authority; they discovered that Neal's Yard Remedies' homeopathic product "Malaria Officinalis 30c" didn't have a product licence even though all homeopathic remedies are classed as medicines and this product was clearly to be used for the treatment or prevention of malaria. The company has now withdrawn this remedy.³

Now the challenge for herbal companies who wish to continue selling their herbal remedies, is to provide the correct information to satisfy the criteria and standards set by the MHRA. It is important to consult a herbal medicines regulatory compliance expert experienced in liaising with the MHRA, and dealing with regulations on a day-to-day basis.