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Subject: | [Health_and_Healing] UK Medicines Act - Herbal Legislation - Implications |
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Date: | Sat, 9 Apr 2011 10:50:35 +0200 |
From: | A van Rensburg <secdogs@mweb.co.za> |
Reply-To: | Health_and_Healing@yahoogroups.com |
From: sales <sales@nutriglow.com>
Subject: UK Medicines Act - Herbal Legislation - Implications
This email is to inform you about our understanding of the implications of the new legislation (UK Medicines Act - Section 12(2)) relating to the sale of herbal based supplements. It is not fully clear to us what the implications are but we have listed below our current understanding of the situation.
1. The first thing to note is that many of the supplements we sell are completely unaffected. Note that retailers can still sell off any stock they may have of any currently available products even after 31 April 2011.
2. This is how the herbal manufacturer A. Vogel* describes the situation:
"After 30th April 2011, all herbal products judged by the Medicines and Healthcare products Regulatory Agency (a Government bodyâ€"the MHRA** for short) to be medicinal will have to be registered with the MHRA by the manufacturer before being supplied to retailers or consumers. The registration can best be described as an approval process, and will allow products to state clearly what they can be used for. Safety data, such as when not to use the product, will be available for each registered remedy."
3. Certain herbs may become unavailable from the end of April 2011 for an undetermined time (indications are 12-18 months).
The reason is that for these herbs a license will be required in order to manufacture these supplements. This is going to be costly for the manufacturers because the license will only be granted once stringent scientific testing has been performed on the products to ensure they are safe. So some herbal supplements will not be available for a while and there are no guarantees that they will become available.
4. Lamberts have stated that from the beginning of May 2011 these products will be unavailable from Lamberts: Vitex Agnus Castus, St John's Wort, Horse Chestnut, Valerian, Rhodiola, Echinacea, Feverfew, Devils Claw and Milk Thistle (Silymarin).
5. On 11 March 2001 we received an email from Biocare setting out their response to the legislation. This is an extract: "BioCare's approach to the Herbal Medicines Legislation: As you are no doubt aware the 'Traditional Herbal Medicines Product Directive' (THMPD) became law in Europe in 2004 requiring all medicinal herbal products to be registered as medicines under a new category as 'Traditional Herbal Medicines'. Under the original UK Medicines Act, herbal remedies were exempt from licensing as long as no medicinal claims were made for them. However the new legislation removes this exemption meaning all medicinal herbal products on the European market must be either registered under the Directive by 30th April 2011 or removed from the market.
*http://www.avogel.co.uk/eu-herbal-legislation/
**
Medicines and Healthcare products Regulatory Agency:
http://www.mhra.gov.uk/Howweregulate/Medicines/Overviewofmedicineslegislationandguidance/Herbalandhomoeopathicmedicines/index.htm
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http://www.mhra.gov.uk/Howweregulate/Medicines/Overviewofmedicineslegislationandguidance/Herbalandhomoeopathicmedicines/index.htm#2
Herbal medicines
There are three possible routes for herbal medicines to be placed on the UK market:
1. as an unlicensed herbal remedy (no longer applicable after 2011)
2. registered under the Traditional Herbal Medicines Registration Scheme
3. licensed with a marketing authorisation as a herbal medicine.
Full details of these alternative routes and the relevant legislation are available on the website.
Placing a herbal medicine on the UK market
Homeopathic medicines
A homeopathic medicinal product is defined in European legislation (Article 1(5) of Directive 2001/83/EC (external link) as amended by 2004/27/EC (external link) as:
'Any medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States. A homeopathic medicinal product may contain a number of principles'.
Currently, there are two ways in which new homeopathic products may be registered in the UK:
1. the Simplified Scheme.
2. the National Rules Scheme (in operation since September 2006).
The Simplified Scheme
In 1992, Directive 92/73/EC (external link) introduced a Simplified Scheme for homeopathic products. It is regarded as simplified because although the safety and quality of products has to be demonstrated, products are not permitted to make medical claims.
The scheme is restricted to products for oral and external use and does not allow indications (the descriptions of diseases or conditions for which the medicine is intended to be used).
In order to qualify for registration, the products must:
- be for oral or external use - this includes all methods of administration with the exception of injections
- be sufficiently dilute to guarantee their safety
- make no therapeutic claims.
The National Rules Scheme
The purpose of the scheme is to enable homeopathic medicinal products to be registered with indications for the relief or treatment of minor symptoms and conditions (those that can ordinarily be relieved or treated without the supervision or intervention of a doctor).
Applications under the National Rules Scheme must be supported by a dossier of data on quality, safety and efficacy, together with appropriate product labelling and product literature.
Guidance documents on both schemes are available on the website.
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