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.
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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.
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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.
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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.
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Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 1996, SI 1996/482
Amends to set out the fees payable.
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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.
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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?
I would like to see all homeopathic remedies freely on sale, I wouldlike to see combinations sold in all pharmacies as on the continent and freedom to practice for all properly trained and registered homeopaths. then we would have real freedom of choice. There is no need to legislate the remedies as they as safe to use.Comment Tags: Free to buy use and consult.
Anyone should be able to buy homeopathic remedies without a prescription, because they are safe and without side effects. The Government should promote natural medicine and make it easier for the general public to access information about it and use it, rather than tieing us all up in red tape. Homeopathic is simple, if it works, people will always want to make use of it, so lets make it easy then!Comment Tags: freedom of choice for natural medicine and homeopathy
Aside from some minor legitimate concern for the standardization of homepathy laboratories, there is every reason to not legislate homeopathy. I have yet to hear of any labs sellling bogus remedies. Other than this relatively non-issue, leave homeopathy alone. Big pharma, big money competes by trying to kill the competition. They need to market fear and attack others because they know full well that what they sell is poison to people, animals and the environment. Thus they can do nothing but buy the media and the politicians using lies and more lies to push their nefarious agenda. It is the truth they subvert because they cannot stand up to the reality of their harmComment Tags: big pharma, homeopathy, Legislation
There is absolutely no need to regulate the supply of safe and effective homeopathic remedies. I suspect that the regulation is more to do with limiting or even nullifying the challenge which homeopathy presents to allopathic medicine and the pharmaceutical concerns.Comment Tags: give freedom of choice, Homeopathy is safe and effective
Conventional scientific thought is that homeopathy is merely the ‘placebo effect’. Those of us who use and prescribe the remedies know otherwise (ask my cat!). With iatrogenic disease increasing all the time, why limit the availability of a safe and effective form of medicine which, in my opinion, will before long become an essential way of dealing with disease when conventional drugs are shown to be the dangerous tools that they are. So many people I know are on several prescribed conventional medicines just to treat the side effects of the original ones but they don’t seem to realise that until it’s pointed out by someone interested in their health and not in the profits of pharmaceutical companies. Homeopathic remedies are cheap to produce and harmless. However they should be regulated to ensure their preparation is safe and consistent, so that the public and homeopathic practitioners have that security – but not made completely inaccessible!Comment Tags: cat, iatrogenic, schaffeler
I think all homeopathic medicines should be exempt from all regulations concerning prescription. Homeopathy is not about drugs or herbs so does not represent a risk to others which needs regulation! So cut the red tape.
In respect of systems of medicine, the Western world are the underdeveloped countries. Everything in science is based on mathematics and physics as the basic sciences. When newtonian physics is replaced by more recent knowledge in quantum physics, the other sciences need to change accordingly. Hence the time has come to make energy and information medicine more available, not restrict it .
Get rid of unnecessary regulation of Homeopathy, unless and until there is any proof that Homeopathic remedies are unsafe.
Homeopathy does not work like conventional medicine. It is about the “energy” left in a substance -the absence of anything harmful. Conventional medicine doesn’t believe it works arguing that the medicine is NOTHING in a sugar pill. A placebo. Those of us who use homeopathy are perhaps amused a little that anyone would wish to regulate homeopathic medicines at all. My view is simple – exempt all homeopathic medicines totally from all regulations concerning prescription. Have some regulation to ensure the quality of medicine manufacture is appropriate – but this should be under the control of homeopathic professional bodies and not pharmacists.Comment Tags: no regulation for homeopathic medicines
Homeopathy is safe to be used by everyone from pregnant mothers, during childbirth, newborn babes, right through and including the elderly. It is safe to use with every other medicine and therapy. It can be used as an alternative and equally as a complementary medicine. We need to ensure people keep the right to choose homeopathy if they wish too. We need to ensure that the access we have at present is not restricted in any way.Comment Tags: Freedom to choose …, Homeopathy is safe.
I am very worried about restricting the use of homeopathic medince. I was sceptic for years but have seen homeopathy help babies and animals, both groups can’t judge what remedies they are given. Homeopathy has no side effects. The side effects of numerous allopathic medicines developed in chemical laboratories though, are numerous. Additionally, research scientists who live and work in the prestigious medical research labs in South Cambridgeshire and who live in my community believe that homeopathy is the medicine of the future. Let us not allow EU regulations block UK citizens’ human right to free and easy access to healthcare of their choice, in particular Homeopathy which, as an oversight, could be outlawed on a legal technicality of the revised Medical Act’s wording.
The drafting of the UK 1966 Vetinary Act, without careful thought to Homoepathic access for animals, excluded Homeopaths from treating animals, unlike most of the Western World. The UK farmers are dependent on antibiotics for the health management of their herds. There is now a trend developing for farmers to train in homeopathy so that they can treat their herds without the need for frequent use of antibiotics. It is great to see that there could be a reduction in the antibiotics present in our meat and the acknowledgement health benefit that will bring to UK citizens. Let us not repeat history by making the same inadvertent mistakes in the final drafting of the revised Medical Act to now exclude access to Homeopathy for UK citizens.
I would appreciate meeting with Andrew Lansley to cover my main points succinctly. In addition, I will support the government in contributing to their website.
I think that as homeopathic remedies are entirely safe to use, they should be on a voluntary basis.Comment Tags: Homeopathy is safe to use, whatever your situation, where you are pregnant or in old age!!
Firstly, homeopathy is safe. It is so safe that it is considered by anti-homeopathy groups to be a placebo. Well, those people don’t need to buy homeopathy but the rest of us would like to have the choice to buy such safe products. Please consider legislation to help encourage public freedom of choice.Comment Tags: choice
How come we’re wasting so much time and energy on this when pharmaceutical companies accrue massive profits and iatrogenic disease is the 3rd leading cause of death in the US? Did anyone ever die of a homeopathic remedy? No – I think all those folks taking homeopathic overdoses on camera told us that. So why can’t we just let people who want to choose homeopathy, choose it? They’re paying privately therefore not taking up NHS resources and so we should be cheering them on not holding them back. If we want the NHS to become more burdened then sure, ban homeopathic medicines, ban all complementary therapies – and then see how long it takes to get to see a doctor.
If, as has been widely acknowledged, there is nothing in homeopathic medicines then they can’t do any harm. People aren’t stupid, if homeopathy isn’t working for them they’ll bang on their doctor’s door real quick.
Change section 10 so that homeopathic medicines are widely available, make all the labelling clear and representative and then let people CHOOSE. Why would anyone or any business be afraid of people choosing? It’s their right, after all.
It is essential that this is scrapped. People should have thwe right to buy or be prescribed homeopathic remedies if that is what they want to do > This legislation would fundamentally curtail freedom of choice and that is wholly unacceptable.
It is a competely restrictive and unhelpful piece of unwanted bureaucratic legislation.
We need less regulation – the biggest threat to health and safetyfor the public is from a mono control of our health by big pharma – profit and pr base dmedicines that have extremely toxic side effects and very little scientific evidence.
Homeopathy is a safe and effective form of health treatment used throughout the World by millions of informed people.
It should be voluntarily regulated thro the Professional bodies as ther eis no threat to the public .
It must not be allowed to fall into th econtrol of the medical profession or =who in turn are controlled by th ebig corporations intent of profit base dmedicine.
Freedom of Choice in health matters is a prereqisite for a democracy. – we are on a slippery slope to corporate bureaucracy and a loss of many of our freedoms to speak and act freely.We need a government that is not controlled by vested interests and secretly funded pressure groups to pervert and corrupt civil servants and centralised bureaucracies.Comment Tags: Freedom of choice
This strikes me as an attempt by big pharma to strengthen their position by making development of new treatments aswell as the marketing of old too expensive for all but the biggest multinationals.
While I acknowledge some homeopathic treatments are controversial and unproven, others are.
I challenge any idealogical sceptic to try dock leaves on a nettle sting – homoeopathic, traditional and yet proven by pre GCSE level science. It should not cost millions of pounds and the lives of a thousand small mammals to get approval for market.
I am horrified that Section 10 of the draft proposal set out by MHRA will limit the supply of homeopathic medicine from only 5 pharmacies in the country. I am my family have benefitted enormously from homeopathic medicine for years and I trust my homeopath completely with the supply of it. The proposals will have a great impact on my treatment, have the opposite effect of increasing patients’ choice, and would highly likely result in a risky unmonitored supply of medicines via the internet.Comment Tags: supply of homeopathic medicine
I believe that regulations on homoeopathic remedies should be scrapped altogether, they are perfectly safe
and can be classified easily by the fact that they have been ‘potentised’ a properly verifiable scientific process that renders them safe and effective. They should be readily available to all and promoted as suchComment Tags: homoeopathic
Homeopathy is a non-toxic system of western medical science originated in Germany. A basic principle of solvent chemistry states that a substance will be a solvent to another substance when it has a similar type of molecular bond. Immunology applies the Principle of Similars to activate antibody responses with small doses of a similar substance that will evoke the allergic symptoms.
In 1790, Hahnemann became the first person in the history to test the effect of drug (Cinchona) on healthy human being. First Double-Blind Randomised Placebo Controlled Trial (DBRPCT) was conducted by a homeopath Johann Jacob Reuter. Blood Pressure measuring instrument Sphygmo-graph was invented by a UK homeopath Robert Ellis Dudgeon.
As far as people demand quality multi-dimensional homeopathy health care, governments are obliged to provide. Till 2010, there have been 220 human studies published in 95 peer-reviewed international medical journals including 17 meta-analysis, 2 systematic reviews and 2 Cochrane Reviews in support of homeopathy.Comment Tags: #regulation, government, homeopathy