Posts
‘Q & A’ FACTSHEET ON THE TRADITIONAL HERBAL PRODUCTS DIRECTIVE
What is the regulation and who is responsible for the changes?
Up until now, it has been possible to sell certain herbal products without a licence under Section 12(2) of the Medicines Act. Examples include St John’s Wort, Echinacea, Milk Thistle, and Valerian. They cannot be sold with a brand name, only the name of the herb and the process can be used, for example Echinacea ‘Herbal Remedy’ and ‘A purple coneflower’. The manufacturers cannot make medicinal claims and cannot use pictures to indicate usage either. Products are usually single herbs but can combine two or more Section 12 herbs. Labelling must not suggest they are Food Supplements, for example packaging gives ‘EXP’ (expiry date), not ‘BBE’ (best before end date).
The Traditional Herbal Medicinal Products Directive came into force on 30th October 2005. The aim of this Directive is to establish a harmonised legislative framework for traditional herbal medicinal products. The Directive included a seven year transitional period whereby products legally on the market prior to 2004 could continue to be placed on the market until 2011. From 30 April 2011 all herbal medicinal products placed on the UK market will need a THR (Traditional Herbal Registration) or product licence, following assessment by the MHRA (Medicines and Healthcare products Regulatory Agency), which is an executive agency of the Department of Health.
What are the changes and what will they mean?
Herbal products are currently sold in the UK under three categories: food supplements, unlicenced herbal medicines and licenced medicines.
A simplified registration scheme, the Traditional Herbal Medicines Registration Scheme has now been introduced. Products are required to meet specific standards of safety and quality and be accompanied by agreed indications, based on traditional usage, and information for the patients on the safe use of the product. Traditional Herbal Medicines are used for self medication and this means that they must be suitable to buy over the counter, for use without medical supervision.
When do the changes come into effect?
The changes come into effect on 30th April 2011. After this date, retailers will be allowed to sell through their excess stock, provided its shelf life permits. However, retailers will not be able to legally purchase any more stock from their suppliers after 30th April 2011.
Why did the regulation come about?
The Directive aims to provide customers with the knowledge and assurance that the herbal medicinal products they are purchasing are safe and contain what is stated on the pack. Registered products will contain an approved patient information leaflet, which will explain how to take the product and will provide information on side effects and interactions with other medicines.
What are the benefits?
The aim of the new legislation is to ensure products on the market are safe and meet specific quality standards. Customers will also benefit because products will have indications for their usage. For example, there are now new Echinacea products on the market that have, for the first time, indications for relieving the symptoms of colds and ‘flu.
What products are affected by this legislation?
All herbal medicinal products placed on the UK market will need a THR (Traditional Herbal Registration) or product licence, whether they are sold singly, in combination with other herbs, or in combination with other vitamins or mineral supplements.
There is no definitive list of herb products that will be affected by this legislation. Some typical examples are: St John’s Wort, Echinacea, Milk Thistle, and Valerian.
Why have some of the names of the products changed?
Under the Traditional Herbal Registration scheme products can now use brand names.
What categories of products have been registered so far?
So far only herbal ingredients that have proven traditional use for over 30 years in the medicinal use of the product have been registered. Most products that have already been registered are single herb products – examples are Valerian, Echinacea and Sage. Many companies are focusing on their ‘best-sellers’ first. Some companies are still in the process of registering their products, so more herbal medicinal products registered under the THR (Traditional Herbal Registration) scheme will become available later this year and afterwards.
Will the price of the products be affected?
The price of some products will increase, due to the cost to the manufacturer of the registration process. Some products, however, will not increase in price.
What products are unaffected by the regulations and will be remaining on the market without a THR (Traditional Herbal Registration)?
Products with a history of food use can continue to be sold as food supplements, with no medicinal claims. Examples here include cinnamon, dandelion, garlic, ginger and liquorice.
How long will I be able to continue to buy my product for?
From 30th April 2011, all herbal medicinal products placed on the UK market will need a THR (Traditional Herbal Registration) or a product licence. Retailers will be allowed to sell stock that they have already purchased before this date, but cannot purchase any new stock. You will be able to continue to buy your products whilst stocks last.
How do I know if I will be able to still get my product?
This will be on a product by product basis. For up to date information, please visit The Nutri Centre website at http://www.nutricentre.com/. You can call also The Nutri Centre Call Centre on 020 8742 8450. The staff in the Call Centre will be able to advise if we still have the product you are looking for in stock.”
What can I do if my product is no longer available?
If the product was recommended by your own nutritionist/nutritional therapist, we would advise that you go back to that person for a suitable alternative. Otherwise, please call our nutrition advice line on 020 7436 5122 (choose option 2) and one of our qualified nutritionists can look for a good alternative for you. This service is provided free of charge.
Will the strength of my product remain if it is now a registered traditional herbal medicine?
You might find that the strength of the new herbal medicinal product has changed from the product you have been buying. This is because the strength of the product needs to be within an acceptable range as demonstrated by the traditional use and safety of the herbal registration.
Some products will have the same dosage and will keep exactly the same formulation. Customers should read the product label and the patient information leaflet for full information.
How do I know whether my product has changed?
All products registered under the scheme will include a nine digit registration number starting with the letters THR on the product container or packaging – e.g. THR 123 456 789
A certification mark has been designed as an additional visible symbol to help consumers more easily distinguish those products benefiting from a THR (Traditional Herbal Registration) from those which do not. If the product you purchase has been registered under the new regulations, the product packaging will have a THR certification mark that looks like the one below:
The THR certification mark is a type of trade mark. It indicates that the herbal medicine has been registered with the Medicines and Healthcare products Regulatory Agency (MHRA) under the Traditional Herbal Registration (THR) scheme and meets the required standards relating to its quality, safety, evidence of traditional use and other criteria as set out under the Traditional Herbal Medicinal Products Directive (THMPD) 2004/24/EC.
Use of the certification mark is not compulsory. Companies can choose whether to include the THR certification mark on their registered products. However, the MHRA is recommending its use in order to help consumers identify those herbal medicines made to the standards set under the THR (Traditional Herbal Registration) scheme.
Why has the packaging now got Braille on it?
Under medicines law Braille is required on the packaging of all medicinal products. Herbal products registered under the THR (Traditional Herbal Registration) scheme are classed as herbal medicines and therefore require Braille on the packaging. The main reason Braille has been placed onto medicines is so that visually impaired people can identify the products in the home making sure they don’t get them mixed up with other medicines that have in their cupboards.
Why are only certain claims allowed?
There must be evidence of traditional use for over 30 years of the active herb(s) in question in order for the claim to be accepted by the MHRA (Medicines and Healthcare products Regulatory Agency).
Does this mean the product I used to buy was harmful?
Only traditional herbal medicines that have been registered can be sold over the counter in future. The unlicenced herbal products were not considered harmful but better regulation was needed on the quality of the herbal ingredients used within these products. Herbal medicinal products registered under the THR (Traditional Herbal Registration) scheme are proven to be both safe and of good quality thereby protecting the public’s interest in the herbal medicines market.
If we’ve not answered your question, please e-mail The Nutricentre at admin@nutricentre.com
More information can be found on the Medicines and Healthcare products Regulatory Agency (MHRA) website at http://www.mhra.gov.uk/.
Specific information on ‘Using Herbal Medicines: Advice to Consumers’ can be found at http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Herbalmedicines/index.htm
If you are a retailer and are still looking for some answers you may find this video clip interesting, click on this link to view:
http://www.bonpomproductions.com/peeled_and_revealed_2_you_me_and_THMPD.html
Wishing you all the best in health,
The Nutri Centre Team
Read more...
