Medicines: Traditional Herbal Medicine
These regulations affect companies who wish to manufacture over-the counter traditional herbal medicines. The purpose of the regulations is to allow consumers to make an informed choice of over-the-counter medicines made to assured standards of quality, safety and patient information.
The new European Traditional Herbal Medicinal Product Directive 2004/24/EC came into effect on 30 April 2004. The aim of this Directive is to remove the differences which create obstacles to the free movement of medicinal products in the European Union, while ensuring protection for public health. This has been done through requiring each EU country to set up a traditional herbal registration scheme for manufactured traditional herbal medicines that are suitable for use without medical supervision.
We want to hear your views on what more we can do to deliver a simpler, less bureaucratic and more effective system, increase choice and opportunity, and maintain necessary safeguards and legal protections.
You can find the regulations that relate to Traditional Herbal Medicines to the left below.
Please note that some regulations in the medicines section also apply to herbal medicines.
|
Medicines (Retail Sale or Supply of Herbal Remedies) Order 1977, SI 1977/2130 Specifies the classes of herbal remedies of which the exemptions from the restrictions stated in the Medicines Act 1968 do not have effect. Read More… (opens in a new window)
|
|
Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005, SI 2005/2750 Amends Traditional Herbal Medicines Products regulations. Measures relate to registration procedures, exemptions, labelling requirements and introduction of offences and penalities for breach of these regulations. Read More… (opens in a new window)
|
|
Medicines (Traditional Herbal Medicinal Products for Human Use) (Consequential Amendment) Regulations 2006, SI 2006/395 This instrument amends the Medicines (Retail Sale or Supply of Herbal remedies) Order 1977. The instrument corrects an error in an amendment to that Order made by the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005 (S.I. 2005/2750) (“the 2005 Regulations”). Read More… (opens in a new window)
|
|
Medicines (Prohibition of Non-medicinal Antimicrobial Substances) (Amendment) Order 1992, SI 1992/2684 Amends the Medicines (Prohibition of Non-medicinal Antimicrobial Substances) Order 1997 to allow the sale and supply of specific antimicrobial substances in medicinal products or animal feeding stuff in certain circumstances; laying down the animal health requirements for EU trade; importing of semen of domestic bovine or porcine animals; and permiting the use of streptomycin and eight more substances as preservatives in products used for artificial animal breeding. Read More… (opens in a new window)
|
|
Medicines (Prohibition of Non-medicinal Antimicrobial Substances) Order 1977, SI 1977/2131 Exempts certain antimicrobials from the prohibition of sales and supply. Read More… (opens in a new window)
|
|
Medicines for Human Use (Prohibition) (Senecio and Miscellaneous Amendments) Order 2008, SI 2008/548 Prohibits the sale, supply or import of any medicinal product for human use containing the Senecio plant species under Section 62 of the Medicines Act and amends three existing Orders to ensure that an exception for goods in transit applies to goods imported from an European Economic Area state which are to be exported to a third country, or an European Economic Area state other than the United Kingdom. Read More… (opens in a new window)
|
|
Medicines (Aristolochia and Mu Tong etc) (Prohibition) Order 2001, SI 2001/1841 Prohibits the sale, supply or import of any medicinal products for human use containing a plant belonging to the genus Aristolochia or from a number of other named species or extract from such a plants, unless certain exceptions apply. Read More… (opens in a new window)
|
|
Medicines (Bal Jivan Chamcho Prohibition) (No 2) Amendment Order 1997, SI 1997/856 Removes the prohibition on the impotation, but not the sale and supply, of the medicinal product known as Bal Jivan Chamco when it is imported from or originates in the European Economic Area. Read More… (opens in a new window)
|
|
Medicines (Bal Jivan Chamcho Prohibition) (No 2) Order 1977, SI 1977/670 Prohibits the sale, supply and importation of a medicinal product for a baby tonic under the name of BAL JIVAN. Read More… (opens in a new window)
|
|
Medicines (Chloroform Prohibition) Order 1979, SI 1979/382 Prohibits the sale or supply of medicinal products which are for human use consisting of or containing chloroform, and provides exemptions from the prohibition including the sale or supply of chloroform as an anaesthetic, for export or for use as an ingredient, in specified circumstances, in the preparation of a substance or article. Read More… (opens in a new window)
|
|
Medicines for Human Use (Kava-kava) (Prohibition) Regulations 2002, SI 2002/3170 Prohibits the sale, supply or importation of any medicine which consists of a plant or plant extract belonging to the species Piper Methysticum (Kava-Kava) the exceptions being where it is for external use, the enforcement of Medicines Legislation and imported or exported to an EEA state other than the UK and where it is subject to product licence, marketing authorisation or homeopathic registration. Read More… (opens in a new window)
|
|
Medicines (Phenacetin Prohibition) (Revocation) Order 1996, SI 1996/3269 Revokes the Medicines (Phenacetin Prohibition) Order 1979 which prohibits the sale and supply or import of any medical products containing Phenacetin subject to exemptions. Read More… (opens in a new window)
|
|
Medicines (Stilbenes and Thyrostatic Substances Prohibition) (Revocation) Order 1997, SI 1997/1727 Revokes the Medicines (Stilbenes and Thyrostatic Substances Prohibition) Order 1982 as part of the implementation by the Animals and Animal Products (Examination for Residues and Maximum Residue Limits) Regulations 1997 of Council Directive 96/22/EEC which relates to the banning of the use in livestock farming of certain substances having a hormonal or thyrostatic action and of beta-agonists. Read More… (opens in a new window)
|
|
Herbal Medicines Advisory Committee Order 2005, SI 2005/2791 Establishes the Herbal Medicines Advisory Committee to advise on issues relating to herbal medicinal products. Read More… (opens in a new window)
|
Tell us what you think should happen to these regulations and why, being specific where possible:
- Should we scrap them altogether?
- Could their purpose be achieved in a non-regulatory way (eg through a voluntary code?) How?
- Could they be reformed, simplified or merged? How?
- Can we reduce their bureaucracy through better implementation? How?
- Can we make their enforcement less burdensome? How?
- Should they be left as they are?
The simplest way to deal with the THMPD would be to scrap it altogether. The only people positive about this legislation are large foreign companies, that can easily afford the huge costs of licenses and are keen to take market share from UK companies being forced out of business.
If it is not possible to scrap altogether, I would suggest the MHRA provides a list of herbs that it deems to be Botanical Food Supplements and it has no further involvement with those. It could then provide a list of herbs that it deems to be Traditional Herbal Remedies with recommended strengths, doses, contraindications, warnings and permitted claims. The industry could then self regulate in line with that guidance. If the MHRA felt it still needed to be able enforce this legislation it could ask manufacturers to provide evidence of GMP for a licence fee of a few pounds per year. All stability tests should be scrapped allowing minor variations in strength due to natural varying harvest conditions. Manufacturers should be allowed to revert to 5 year best before dates for tinctures (phytochemicals preserved in alcohol) which never caused any problems before this hugely bureaucratic and unnecessary legislation came into force.
The MHRA should also drop its ridiculous interpretation of the word “organic” as promotional. Wording linked to organic production should be approved by an organic certifying body such as the Soil Association and the MHRA should have no involvement in product names.
This Red Tape Challenge could be the best news for the Herbal Medicines industry since it became apparent the pharmacists at the MHRA were going to take a heavily bureaucratic approach to implementing the THMPD. Please don’t waste this opportunity to scrap this legislation.Comment Tags: Herbal. Licences, MHRA, Organic, Red Tape, THMPD, THR