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.
Read More… (opens in a new window)

|
|
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)

|
|
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)

|
|
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)

|
|
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)

|
|
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)

|
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?
The regulations should be reviewed and consolidated to create a single piece of legislation to cover homeopathic products and other ‘alternative’ medicines such as herbal remedies. No products, herbal or homeopathic, should be allowed to make claims of efficacy or safety until and unless they have met the same strict criteria as all real medicines. They should be forced to state on the packaging, in an easily read font, that they have not been proved to be either safe or effective until they have met this criteria.
Hold homeopathic medicines to the same standards as other medicines. If they can be proven to be effective then they need regulating like all other (effective) medicines. If they can’t be proven effective then labelling should reflect this. In either case the label should also state how much of the ‘active’ ingredient is present. The standard of evidence required to demonstrate efficacy should be identical to that for other medicines – there is no good reason why homeopathy should be given special treatment. If a homeopathic remedy can be shown to work, sales will be boosted. If it can’t, the public ought to be informed of this when deciding whether to buy homeopathic medicines.
All products sold as medicines or remedies should be treated equally: the legislation will then be simplified by not having special cases. The onus must be on the manufacturer to demonstrate, via properly conducted double-blinded randomised control trials that they are both safe and effective. Homoeopathic products meet the first criterion (owing to the absence of active ingredients) but not the latter (same reason). Labeling must include all, and only, those constituents that are verifiable by chemical analysis. Purveyors of homoeopathic products must not be allowed to use special pleading to be exempt. If they really believe that their products are effective, they should not object to their being treated in the same way as proper medicine.Comment Tags: Homoeopathy labeling RCT
Homeopathic products are worthless and should be considered fakes. The only regulation needed is very simple. Ban their sale.Comment Tags: worthless
I think that all the pharmacies who are producing homeopathic remedies are very aware of marketing safely and many provide support on how to take remedies etc. The safety of using homeopathic remedies has been empahsised widely. The manufacturers provide a high quality service and source their products in safe way which in my view is the most important. In other words they apply quality control measures and their information is of high quality and serves the needs of the laymen. I am for simplification and also for reducing any unnecessairy bureaucracy which in my experience inhibits many initiatives and distracts manufacturers, and practitioners (in homeopathy) from making more of a difference in helping those that seek their expertise. I am Swiss and the Swiss government has recommended Homeopahty to be covered by the Swiss national health service. Now that is an endorsement which speaks for itself and has been made after a very thorough process. For this statement tobe made it is as usual (in Switzerland) backed up to the hilt.
To conclude, It hink that no changes other than simplification and an effort to clarify things for everyone ought to be done.
yours truly,
Pierre
There is absolutely no need to change the regulations regarding homeopathic remedies. Homeopathy has been practiced and homeopathic remedies have been taken, in this country and worldwide for over 200 years. Unlike many conventional medical drugs, homeopathic remedies are safe and do not have any side effects. In view of the current backlash against homeopathy sponsored by the pharmaceutical industry, this feels like another thinly veiled attempt to make remedies more difficult to obtain and therefore eventually eradicate the practice of homeopathy entirely. If, by the nature of your proposal, you are suggesting that the general public have become more stupid in the last two hundred years and as such require more protection in line with the rest our ‘nanny’ state, I would strongly suggest that you simplify and summarize the regulations so at least the public have the opportunity to understand them and comment for themselves.
Leave it alone, when you brought in new legistation for herbs it just meant less herbs available to the consumer. Homeopathy is safe and effective – there is not one example of death by homeopathy lets compare that to pharmaceutical drugs – go and reign them in! All homeopathic remedies, all potencies, every substance used, as freely available as always, and more money into research and awareness, and far more availability on the NHS.
I agree with Melanie Tomsett: ” The remedies should be as readily available as they have always been, in all potencies, in every substance that is currently available with newly proven remedies being available freely.”
Don’t try to confuse the public about the Homeopathy with smartly described pseudo-scientific terminologies; playing for time waiting on evidence, which may prove that Homeopathy is or unsafe or useless; with ridiculous and pragmatic regulations because Homeopathy is THE cure without side-effects and do no harm like the “western drugs”. Homeopathy is safe; its effect is smooth and painless and lasts for long and it’s cheap. The Homeopathic cure is compassionate and organic.
Regulate:
- corruption
- greed
- child trade
- women trade
- slavery
- pornography
- drugs (western medicines)
- weapons (no weapons at all shall be available for the public!!!) and its trade
gun-running
- safety on the highways
- petrochemical companies and its activities
- GMOs and GEs (non of these activities shall be allowed at all and the ideals makers and the perpetrators should be penalized with strongest possible penalties (not death but there are really strict retributions)!!!!))
- and the list could be carried on…
In my understanding of the proposed changes to regulations, cutting the red tape surrounding homeopathic medicines means that the medicines will no longer be available to patients, public or practitioners without visiting the pharmacy in person. Make sure you read the proposals before you comment on this site please.
The remedies should be as readily available as they have always been, in all potencies, in every substance that is currently available with newly proven remedies being available freely.
All homeopathic remedies are currently manufactured safely regardless of the primary substance. In my experience, having used homeopathic medicine for many years, I have never known them to have any side effects. Pharmaceutical drugs, on the other hand, are not necessarily manufactured, tested or prescribed safely. Up to a million Britons are hospitalised by prescription medicines every year, costing the NHS £2 Billion, and ADRs are the 5th leading cause of death in Europe costing £79 billion (and these are just the ‘official’ statistics which often err on the lower side of the scale). I also agree with the comment which says that this website needs to be written in more laymans type language as it can repel people from writing their comments. I also agree that this debate should be publicised more widely to truly allow the general public to have their say.
In my opinion, the general public are not well educated about what homeopathy is. A simplified explanation is that the homeopathic medicines resonate energetically with the person taking them and if prescribed according to the principle of treating like with like (not exact same with exact same) the resonance in the body stimulates self healing to the best level possible in that person at that time – that is a very simplified version. Despite that, as a registered homeopathic professional with over 12 years of prescribing homeopathic medicines, i would still like my clients to be able to access a selection of them with strong indications for first aid / acute ailments in their local pharmacy. Homeopathic medicines are not toxic, non-addictive & have no side effects (unless someone does a homeopathic proving with them, in which case short term symptoms of the medicine will arise). I agree that production of homeopathic medicines need to adhere to stringent quality control to ensure members of the public and practitioners feel safe & confident in their use. I am not aware that the current legislation is failing us at that level so i would suggest that it is reviewed and made current with as little bureaucracy as possible. One suggestion would be to review the instructions for use on click packs which currently suggests that the user take 2 pillules every 2 hours. This could be reviewed with the manufacturers, although i recognise that it is difficult to advise on, as frequency and quantity depend on the condition and the state of the person using the product.
I am pro legislation that ensures quality homeopathic remedies, i.e. that the production, transport and storage has been performed according to homeopathic requirements. Since each remedy is capable of aiding an array of different health complaints it is not possible to list these all on the product label. Listing only one indication leads to misunderstanding. Which remedy is required depends on the person not on the health problem. The number of homeopathic remedies on the market should remain as there are or be expanded on via provings (homeopathic clinical trials). It should be understood by legislation makers how homeopathy works and how the efficacy of homeopathic remedies should be correctly assessed before in- or excluding any remedies based on efficacy.
There needs to be no change to the legislation and rules regarding any aspect of homeopathic remedies.
However, it would be very useful for the general public if you were to write your proposals in an easy to understand format instead of the gobledegook language that is your prefered method of communication. Also, this information should be made easy to find and the debate should be more widely publicised to enable a larger proportion of public comment.
The regulation of homoeopathic medicine should be aimed at the people who make it and supply it, however I thought that the effect of homoeopathy was only placebo, so why the interest? I have over 20 years using this safe non toxic medicine as an applied science, professionally. I have never encountered an adverse effect.
I don’t understand all the current legislation, however, I have used homeopathic remedies safely and effectively for over 15yrs. Marketing of homeopathic products to the public allows a helpful alternative so people can make informed choices about proactively managing their health. Therefore basic guidelines for use need to be included, however the individual response to remedies can make this of limited use.
Legislation should be directed to safety of manufacture.Comment Tags: homeopathy, informed choice
The regulations are sufficient. Please keep them as there are. Homoeopathy is safe and gentle does not do any harm to any body. What about peoples choice!!!!!!
I think the regulations in place are sufficient, let’s keep them as they are and avoid further ‘red tape’. Homeopathic medicines are gentle, safe and effective and freely available throughout Europe – the Swiss government report on Homeopathy has shown it to be a valuable, cost-effective part of their health system. Around 6 million people in the UK benefit from homeopathic treatment. This form of medicine should be more widely endorsed and not subject to further regulations.
According to the Swiss government report on Homeopathy, it is safe, cost effective and efficacious.
Their working group took several years to scientifically assess many well-conducted studies and have written a carefully considered report recommending homeopathy to be covered by the Swiss national health service.
I cannot improve on these findings, they are above board and prove that homeopathy is a viable modality, and would
save the health service many dollars in more expensive treatment, which has also greater possibility of unwanted side effect.
I have experienced extremely good results being treated homeopathically, and if you can’t believe your own experience, what can you believe?
Yours sincerely,
Ian RobinsonComment Tags: The Swiss Government Report proves Homeopathy is safe and effective.
Pharmacuitical regulation of Homeopathic remedies should be allowed to remain as they are. this is an old science applied as an art. It is not the science of Homeopathy that should be reviewed but a final accept of this amazing art
regulation should be minimised. If it were possible to combine the three pieces of current legislation into one set of simplified regulation this would be a good outcome. Homeopathic medicines cause no harm and in other European countries are freely available. In Switzerland they are considered by Government to be both effective and value for money. This government should take the same view.