Medicines: Homeopathic Medicine
These regulations affect companies who wish to market homeopathic medicines. There are currently three schemes in the regulations that apply to homeopathic medicines. Product Licences of Right (PLRs) were issued to all medicinal products on the market at the time that the Medicines Act 1968 was implemented (in 1971). Homeopathic products covered by PLRs may have indications. The Simplified Registration Scheme was introduced in 1992. Products registered under this scheme have been shown to meet safety and quality requirements but are not permitted to be labelled with indications.
A National Rules Scheme allowing homeopathic products to be indicated for the relief or treatment of minor, self-limiting conditions was introduced in September 2006. PLR holders are encouraged to re-authorise their products under the National Rules Scheme, which provides a more secure regulatory position.
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 Homeopathic Medicines to the left below.
Please note that some regulations in the medicines section also apply to homeopathic medicines.
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Medicines for Human Use (National Rules for Homoeopathic Products) Regulations 2006, SI 2006/1952 Amends the Medicines for Human Use (Marketing Authorisations) Regulations 1994, to introduce a new scheme for homoeopathic products. A definition of a “national homoeopathic product” is given and specific rules for marketing authorisation applications for such products are introduced. Read More… (opens in a new window)
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Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 1994, SI 1994/899 Amends the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994. Measures include criteria for determining whether a product is sufficiently dilute to guarantee its safety. Read More… (opens in a new window)
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Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005, SI 2005/2753 Amends the regulations which implement the EU legislation relating to registration of homoeopathic medicinal products for human use that may be placed on the market in the United Kingdom. It implements the provisions relating to the grant, suspension and revocation of certificates of registration and the obligations of certificate of registration holders. Read More… (opens in a new window)
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Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994, SI 1994/105 Implements provisions on medicinal products and homeopathic medicinal products. In particular they bring into operation for homeopathic medicinal products for human use a simplified registration procedure. Read More… (opens in a new window)
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Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 1996, SI 1996/482 Amends to set out the fees payable. Read More… (opens in a new window)
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Medicines (Labelling and Leaflets) Amendment Regulations 1994, SI 1994/104 These regulations impact upon medicines consolidation and patient information exempting homeopathic medicines from certain labelling regulations applied to other types of medicines, providing definitions of certificates of registration and homeopathic medicines and defining the requirements for leaflets provided with homeopathic medicines. Read More… (opens in a new window)
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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?
Homeopathic remedies should not be covered by this legislation. As I understand it, this legislation was designed to regulate the supply of pharmaceutical drugs and was not drafted with homeopathic remedies in mind. Homeopathy is a safe and effective healing methodology. Whilst “sceptics” argue that it is no better than placebo I have seen it work well on babies and animals where no placebo effect would be operative. Consumers of homeopathic remedies use them to maintain and improve health and generally take responsibility for their own treatment, without reliance on the NHS. The consolidated act would in effect restrict both ordinary consumers and homeopaths to the sue of only a comparatively small number of remedies as “unlicensed” remedies would only be available face to face form a homeopathic pharmacy of which there are very few. Given that homeopathic remedies and treatment is at worst benign and at best beneficial what possible purpose could be served by effectively restricting access to homeopathic treatment in this way? Surely an amendment could be made to the legislation which would allow for the purchase of unlicensed homeopathic medicines by mail order /internet or phone rather than enforcing their purchase face to face?Comment Tags: freedom of choice for homeopathy and natural medicine