By Laura Farhall

Herbal remedies have been used to help with a range of medical conditions and ailments  for thousands of years yet, despite their popularity, the sale of herbal medicines has never been subject to a huge amount of licensing and regulation…until now.

From the 1st May 2011, all traditional herbal medicinal products are required by law to be registered by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the new Traditional Herbal Registration scheme –  but what exactly does this mean?

What is a traditional herbal medicine?

Some plants contain substances which may help treat diseases and medical conditions. Medicinal products made from these substances are known as ‘Herbal medicinal products’. Even though these products come from natural sources they might interact with other medicines or have side effects.

What makes a herbal medicinal product eligible to be registered?

It must have evidence of 30 years medicinal use, 15 of which must be within the European Union and must comply with stringent manufacturing guidelines to ensure the product is manufactured to pharmaceutical standards. The manufacturer must provide accurate information about the product dosage, when it should be used and any side effects and medicine interactions that have been reported previously.

Who regulates the products and supplies the registration?

Herbal medicines will be regulated and licensed by the Medicines and Healthcare Products Regulatory Agency (MHRA). To grant a license the MHRA will asses each product for safety and quality and approve clear and accurate information about how it can be used for medicinal purposes.

How much does each registration cost?

Depending on the product and how many other licenses for the same herb have been granted previously the cost will vary. According to the MHRA’s website a license for a previously registered herb will cost between £2,500 and £3,000 and significantly more for a new licence. This will be a major investment for those manufacturing a large range of supplements.

Are any herbal products allowed to remain on the market as food supplements?

A herbal product will be considered medicinal and require a license when it contains properties that treat or prevent disease in humans or where it has a pharmalogical, immunological or metabolic action.  However, some herbal products are considered a food supplement if they are safe for consumption and can be found in their original form on your kitchen shelf i.e. turmeric. Food supplements will not have an indication.

What will happen after the deadline of 30th April?

Only unlicensed products that are already ‘on shelves’ on this date will be available for sale – further manufacturing of this product will be prohibited.

For further details and the latest updates visit the MHRA website.