Elsewhere in the whereas, you should see #22. For articles, see #13 – #15, specifically #13.2:
“Member States shall establish a special simplified registration procedure for the homeopathic medicinal products referred to in Article 14.”

Interestingly, in article 14, which defines the products for which this simplified registration procedure is available, it states
“no specific therapeutic indication appears on the labelling of the medicinal product or in any information relating thereto”

This contrasts, at least for me, with the MHRA’s press release:
“… companies will be allowed to include information about the treatment and relief of minor, self-limiting conditions based on the use of the product within the homeopathic tradition. For example, labels may indicate that a product may relieve the symptoms of common colds and coughs, hay fever or chilblains”.

I think I’ll have a word with some friends in the commission, since a few of them are around today, about whether or not they think the 2 are compatible.

TB – suggest you stop being such a sarky git when you don’t know what you’re talking about

“…treatment and relief of minor, self-limiting conditions…”

I think the “clue” for all those with more money than sense (users of homeopathy, traditional chinese quackery, etc) is the term “self-limiting”. Hint: these things get better on their own!

Interestingly, here in Switzerland which is a hot-bed of homeopathy and other related clap-trap (German influence perhaps), homeopathy has just stopped being supported by the basic obligatory part of our heath insurance. So now at least you have to pay for it yourself or include CAM in your optional-extras cover.

Please don’t drop this one.

What next – the MHRA enhancing consumer confidence in bear gall bladders, tiger penises and rhinoceros horns?

I agree with sfluendy: we should get the noodly appendage of the flying spaghetti monster (www.venganza.org (and that’s a url worth translating into English)) endorsed by the MHRA as valid therapy for, well, everything really.

“5. The MHRA is the government agency that is responsible for ensuring that medicines and medical devices work, and are acceptably safe. We keep watch over medicines and devices, and we take any necessary action to protect the public promptly if there is a problem. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.”

Surely the key sentance here is the first one which say’s “ensuring that medicines and medical devices work, and are acceptably safe”

Now nobody can argue that the sugar pills are safe (unless your diabetic maybe?) as they effectivly have no active ingredients but i’m fairly sure they could be hung out to dry on the first bit about them having to work…….

Look at his carefully:

(7) The concepts of harmfulness and therapeutic
efficacy can only be examined in relation to each
other and have only a relative significance
depending on the progress of scientific
knowledge and the use for which the medicinal
product is intended. The particulars and
documents which must accompany an
application for marketing authorization for a
medicinal product demonstrate that potential
risks are outweighed by the therapeutic efficacy
of the product.

(8) Standards and protocols for the performance
of tests and trials on medicinal products are an
effective means of control of these products and
hence of protecting public health and can
facilitate the movement of these products by
laying down uniform rules applicable to tests and
trials, the compilation of dossiers and the
examination of applications

—————–

semms to me that they could have insisted on trials to prove efficacy if thay had wanted to.

Hiw should the Daily Mail react to this? Bash woo, or bash the Germans? Quandries like these show how difficult tabloid journalism can be.

Bob

This happened to Germany with a dfferent part of this directive and Germany lost hands down (no link, but I work for an agency of the commission).

To be fair to the MHRA (something I’m loth to do since I used to work there), this is not their fault at all, and the press release and Kent’s quotes are them putting the best possible spin on something they *really* don’t want to do. The Times’ use of the phrase ‘The MHRA has now taken advantage of a new EC Directive…’ is disingenuous. The UK governement has implemented the directive and the MHRA is doing what it’s supposed to, which is doing the practical bits of enacting UK and EU legislation within the UK. The government has actually taken as long as they realistically could in getting around to this. 2001/83 was supposed to be fully implemented into national legislation by 31 October 2005, and other parts of the directive have been in place in the UK since way before then. At least they dragged their heels on it.

If you want anyone to blame, blame the Germans. They *heart* their homeopathy and it will’ve been their lobbying that got the relevant articles into Directive 2001/83/EC. If you want to blame someone closer to home, then try our parliamentary system which didn’t properly scrutinise the legislation and reject these clauses long before 2001.

Sorry for the long post

“These Regulations make amendments to the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 (“the 1994 Regulations”), which implement the provisions of Directive 2001/83/EC on the Community code relating to medicinal products for human use (“the 2001 Directive”)[5] relating to marketing authorisations, to introduce a new scheme for applications for such authorizations for certain homoeopathic medicinal products. Article 16(2) of the 2001 Directive permits Member States to introduce in their territory specific rules for pre-clinical tests and clinical trials of such products.”

The full text of Directive 2001/83/EC can be found here:
pharmacos.eudra.org/F2/eudralex/vol-1/CONSOL_2004/Human%20Code.pdf

“The MHRA has now taken advantage of a new EC Directive to amend the way homoeopathic products are sold. The changes were introduced by way of a statutory instrument.

The new regulations say: “An application for a national homoeopathic product is not required to comply with the requirement to submit the results of pre-clinical tests and clinical trials.””

What on earth is the EC doing? I wonder whether complying with this directive is optional?

I suppose this past claims things could cut both ways.

he deliberatley said absolutely nothing incriminating against this policy, but his body language suggested he was deeply unhappy with this state of affairs. it was this that lead me to believe that mhra are not that independent of governmental (whoever that may be) policy, and are not that happy about that either. therefore does mhra deserve the kicking people want to seem to give it?

Where does Evan Harris live, I want to live in his constituency…..

www.badscience.net/?p=200

regards what can be done – a judicial review could be undertaken if there are sufficient grounds – strikes me that there might well be in thjis case but youd need some heavy duty legal bods and a pile of money. en.wikipedia.org/wiki/Judicial_review
Its strikes me that several important principles have been violated here – which could provide grounds. Also the consultation proceedure seems pretty lame – had anyone here heard of it? which stakeholders was it sent to. the statutory instruments BTW dont require scrutiny. the bill gets scrutinised and passed the statutory instruments are the detail that is decided after the event.

The regulatory impact assessment (on the consultation page linked above)is also well worth a read. This is the document that is required to be produced by the relevant department for any new proposed legislation

“Its role is to perform a detailed evaluation of the potential impacts of this new regulation and establish whether it would have the desired impact. For instance, it is useful to identify potential side effects or unforeseen extra costs associated with this new regulation. It also helps to clarify the cost of enforcement of the regulation. In general, a RIA is created by an independent team of experts hired by the regulation body.” (wiki)

The RIA itself seems pretty wiffy to me – id be interested to know who was responsible for it.

…things to do today: print a sheet of self-adhesive labels for a dozen different bottled homeopathic remedies, and casually drop the sheet near the pharmacy counter in Boots.