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?
Quite agree except that I’d argue that homeopathic ‘medicines’ most certainly must /not/ be the subject of clinical trials (and I think it’s quite scandalous that many such trials have been carried out). For reasons I’ve explained elsewhere, and which at least some medical scientists have understood (cf. Kimball Atwood’s What Is Science post at SBM), the results of a clinical trial of some homeopathic ‘remedy’ can’t be interpreted as support for the hypothesis of the remedy’s efficacy even when they’re positive. Consequently, homeopathy CTs are futile cargo cult science and in blatant contravention of (medical) research ethics principles.Comment Tags: cargo cult science, research ethics