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.

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.

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EU regulation

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.

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EU regulation

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.

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EU regulation

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.

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EU regulation

Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 1996, SI 1996/482

Amends to set out the fees payable.

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EU regulation

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.

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 UK regulation

Tell us what you think should happen to these regulations and why, being specific where possible:

152 comments on “Medicines: Homeopathic Medicine

  1. I benefited some 24 years ago from homeopathy when conventional medicine gave up on me. In my early 20′s I had lost my hair, my skin was shredding from my body, I was bloated with high dose steroids, I had been hospitalised for weeks and off work for months – I had no choice but to find other things to make me well or give up on the chance of having a ‘normal’ life. Don’t restrict patient choice and patient’s chances to find other solutions to getting well, we are all individual and need to be able to make our own choices about OUR HEALTH and wellbeing.
    I was so impressed by homeopathy that eventually I trained in it and recently qualified. The impact of my original homeopathic treatment stayed with me and my family for 2 decades and my son, now 17 years old, has only ever really been treated by homeopathy and complementary therapies and he is fit and very well ( I can count the ammount of times on my hand when he’s needed to visit our local GP) so in using homeopathy our family alone has saved the NHS vast ammounts of time and cash!
    I really support the fact that people should see a qualifed and registered homeopath to get appropriate advice and treatment, but do acknowledge that for minor symptoms there is a place to purchase products over the counter too as patients have the choice to buy over the counter conventional medications in their local supermarket without speaking to a pharmacist – why should homeopathy be any different?
    As a professional homeopath don’t restrict my right to practice and prescribe homeopathic medicines, it took 4 years of my life to study to become qualified at great financial expense and at the expense of my family sometimes (my time spent studying). Don’t take away my professionalism, my livlihood and my passion to make a difference to all those people who conventional medicine fails.
    With the recent introduction of a single directory for all UK qualified and registered homeopaths it should be easier to set guidelines about enabling appropriately qualified and registered professional homeopaths to prescribe any homeopathic medicine that is appropriate for their patient following a detailed consultation and as part of an individualised treatment plan.Comment Tags: Single directory for registered homeopaths

  2. Sue Smith on said:

    Clarity is needed in the language of the Medicines Act to confirm in law access to the current supply routes for unlicensed homeopathic medicines so that it exempt from restriction. It is safe, effective holistic medicine and should be freely available to all who choose it above potentially harmful conventional medicines, which the original Medicines Act addressed.Comment Tags: choice, Freely available, safe medicine

  3. Liz Brynin on said:

    I feel that homeopathic medicines should be allowed to be sold, distributed and prescribed freely. These medicines have been prescribed by homeopaths and used freely by the general public for hundreds of years without danger. Why change something that is used safely and effectively by so many people for themselves, their families and their animals? If you remove homeopathy on the grounds of safety, then over the counter sales of antihistamines and analgesics should be stopped too. Let patients have freedom of choice for their health, as the government has promised.Comment Tags: effective, Freedom of choice, safe

  4. Suse Moebius on said:

    Until recently, the pragmatist principle of ‘letting sleeping dogs lie’ ensured that, without any red tape, certain regulations governing pharmaceutical practice clearly intended for mainstream drugs only were quietly ignored in the case of homeopathic remedies BY THE REGULATOR. This quiet policy has ensured the ready access to homeopathic medicines by the public, safely and for decades.

    The safety record of homeopathic medicine speaks for itself: no deaths and no litigation in this country, either within the NHS or in private practice. But sleeping dogs are no longer left alone in the current era – ever-tighter regulation affects all parts of life.

    With low-level changes to current regulations (requiring no legislation), the previous status quo can easily be continued – maximising patient choice even where direct access to homeopathic medicines via a specialist pharmacy is not possible (in-person supply from a pharmacist is a key issue in the regulations). The vast majority of the UK’s 5-6 million homeopathy users have no direct access to a specialist homeopathic pharmacy but all users of homeopathic products should be entitled to continued choice and therefore the necessary and well-established modern supply paths such as internet orders.

    Ensuring this is easily achieved, without red tape: some of the relevant sections of current regulations need a change of wording to ensure that freedom of choice for UK consumers can be secured.Comment Tags: Consumer Choice, homeopathy, Safety

  5. Sian Thomas on said:

    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

  6. Sheila Cooper on said:

    I work as a homeopath and I am worried that this legislation will restrict the freedom of access to homeopathy & homeopathic remedies for the public. To remove choice from the public in this way when there is no evidence that homeopathic remedies are dangerous (in fact they are both safe & effective) would be a very short sighted move. An introduction of a clause making homeopathic remedies exempt would safeguard this important freedom of choice and ensure that an effective and safe treatment; that works well alongside conventional medicine would provide the . possibility of ‘integrated’ medicine to become the norm for all practitioners and patients. Homeopathic remedies should not be required to ‘re-authorise’ their products as they have been previously covered by existing legislation and there has been no alteration to their method of manufacture or their action, as is the case with the other medicines covered by this legislation. Last year Government debated on Homeopathy and it is still included under the umbrella of the NHS, as such it is vital that legislation should protect the remedies this treatment uses not remove or restrict them in anyway. Advice on labels to consult a qualified homeopath prior to taking the remedy could become a statutory requirement. Consultation between Government & Homeopaths (via their lead body representatives) could result in dissemination of information available to those of the public who choose to use this treatment via affordable courses (free via vouchers for those in receipt of benefits) ensuring that informed usage would negate the need for labelling with indications.Comment Tags: effective, homeopathy, medicine, safe

  7. Marlow Purves on said:

    The proposed legislation of the sale of homoeopathic remedies is founded upon the notion that remedies can be harmful. This is totally antithetical to the whole foundation of homoeopathy and a call for a blanket piece of legislation is typical of a hypothetical application for ‘all medicines’.

  8. rix Pyke on said:

    I work as a homeopath with people with enduring mental illness who have been subjected to huge doses of pharmaceutical medications over many years. All the people I work with want to be on less medication as they find each drug causes the next diagnosis they get from the psychiatrist. When they begin to use remedies to manage their mental and emotional and physical symptoms they find the drugs they are on become less and less necessary. Homeopathic remedies need to be MORE available. They are safe and yet hugely potent – and cost next to nothing.

  9. Maggi Burnett on said:

    This legislation regarding homeopathy is unnecessary. Regulation for dangerous drugs may help safeguard the public but homeopathic remedies are safe. It should continue to be available as before. In the past it was only available to the wealthy. Everyone should continue to have access to it. No-one is suggesting that everyone must use homeopathy but it should be easily accessible to all those who would choose to use it. I would be hugely disappointed if this government were to curb my freedom to access homeopathy.Comment Tags: freedom to choose homeopathy

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