Guest guest Posted June 16, 2012 Report Share Posted June 16, 2012 Hello Graham, It's a nightmare! I've taken the view that any stock I had in before May 1st 2011 can continue to be sold until it expires or runs out whichever comes first. Also that I can sell cosmetic items, nutritional items and anything else not considered an unlicensed herbal remedy. no claims can be made of course.I continue sending raw ingredients/start up materials direct to practitioners that register with the site and prescription items according to RCHM guidelines. I'm currently trying to get my cookie script working as since 26th May 2012 if your site uses cookies you have to tell users and allow them to disable if they choose. Ironically the script then sets a small cookie to track their preferences! Can't get the darn thing to work yet. Grrrrrrrr! However it has been indicated that no one will be prosecuted over this!I'm afraid that until there are actual court cases you have to interpret the regulations and make up your own mind. I'm not doing anything I can't defend and will support any practitioners I serve in the same vein.Although I do believe some have taken the two fingers approach, not for me I'm afraid...Lorraine Lorraine Hodgkinson AHG MRCHMHERBS AND HELPERS6, Butts Fold, Cockermouth,Cumbria, CA13 9HY. UK.Tel: +44 (0) 1900 826392Mobile: 07761 489838 (O2)www.herbalmedicineuk.comOn 16 Jun 2012, at 11:51, Graham White wrote: Hi All Busy morning for me! The past 3 years have been particularly traumatic for me and I've pretty much dropped out of herbalism completely but (hopefully) things have stabilised and I'm trying to get back into it again. My question is that I have a website (hasn't been updated for at least 4 years!) where I used to sell a small amount of herbs. My understanding is that we can no longer sell unlicenced herbs without a face-to-face consultation, correct? But we can still sell any stock we had when the legislation was introduced (which was when?)? Does the legislation apply to pessaries? If I get an order through the website from outside the EU can I still sell? ThanksGraham White, B.Sc. (Herb. Med.)Medical Herbalist--------------------------------Phone: 01438 213284Mobile: 07740 766335www.gcwhite.co.uk Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 16, 2012 Report Share Posted June 16, 2012 Hello all, Slightly off topic, but anyone with a website having cookie compliance issues might like to look at http://www.civicuk.com/cookie-law/index . It's a free open source cookie compliance solution with deployment instructions. I've seen this used on a number of reputable websites including local authorities. (The real irony of the new cookie law is that even by declining cookies, users will still have most of their web activity tracked by the near ubiquitous use of web bugs, tags and beacons used on many websites. However most people are totally unaware of this covert tracking!) Anyway, I hope someone might find the link useful. Kind regards, Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 16, 2012 Report Share Posted June 16, 2012 Hi Graham,Good to hear you are back!1. The law regarding herbalists making up prescriptions in the UK has not been changed at all. It has never been lawful to supply unlicensed " medicinal products** " , except as a herbalist on a one to one basis etc.etc. 2. Fresh legislation regarding retailing " herbal medicinal products** " was introduced recently BUT actually it didn't change the proscriptive bit - it just opened up a possibility of getting such products registered without doing all the clinical trials etc previously required. It was hoped by the regulators that this would clean up the dodgy dealers BUT:there's Regulation; there's Interpretation......... and then there's Enforcement.We all try to interpret the regs - what it means for you and me - but sadly that seems to be irrelevant because (unless your hobby is developing lengthy Legal arguments), what really matters is how the enforcers interpret it. The hint that everyone seemed to miss was that the Enforcement team repeatedly said that they would start 'at the top' - that is dealing with serious miscarriages of herbal medicines law. Hopefully not your or my problem!!It is expected (is this Politics now?) that, in time, the regs will be enforced all the way down, at which point you might think it sensible to consider the niceties of points such as whether the dried Chamomile herb that you might offer on your own particular website is a medicine or a food supplement (how you sell it could be the point). But Law does also have to take into account common usage, so by then, it will all be a bit clearer. There is no clue as to the timescale of any enforcement. It's obviously been affected by budget cuts that weren't in the plan 6 years ago.So, unless you are going to do something blatantly offensive to the law, it seems unlikely that anyone will take any notice. Kind regards Hi All Busy morning for me! The past 3 years have been particularly traumatic for me and I've pretty much dropped out of herbalism completely but (hopefully) things have stabilised and I'm trying to get back into it again. My question is that I have a website (hasn't been updated for at least 4 years!) where I used to sell a small amount of herbs. My understanding is that we can no longer sell unlicenced herbs without a face-to-face consultation, correct? But we can still sell any stock we had when the legislation was introduced (which was when?)? Does the legislation apply to pessaries? If I get an order through the website from outside the EU can I still sell? ThanksGraham White, B.Sc. (Herb. Med.)Medical Herbalist--------------------------------Phone: 01438 213284Mobile: 07740 766335www.gcwhite.co.uk -- Chenery MNIMH MCPP MSB QPDirector, Rutland Biodynamics Ltd., Organic Medicinal Herb Growers andDepartment of Health (MHRA) Licensed Medicines Manufacturer, Town Park Farm, , Rutland, LE15 8DG, UKEmail: pc@... Website: www.rutlandbio.comConfidentiality: This e-mail and its attachments are intended for the above named only and may be confidential. If they have come to you in error you must take no action based on them, nor must you copy or show them to anyone; please reply to this e-mail and highlight the error. Security Warning: Please note that this e-mail has been created in the knowledge that Internet e-mail is not a 100% secure communications medium. We advise that you understand and observe this lack of security when e-mailing us. Viruses: Although we have taken steps to ensure that this e-mail and attachments are free from any virus, we advise that in keeping with good computing practice the recipient should ensure they are actually virus free. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 20, 2012 Report Share Posted July 20, 2012 Hello, I know this is an old post but I've only just found it. My understanding is that if you wish to present a strong argument to the MHRA that what you're selling is a food rather than a medicinal herb, you need to have some documentary evidence up your sleeve to that effect. That means you have to prove that the herb you wish to sell, and the dosage you recommend must be in line with how the herb was used as a food within the EU pre May 1997. The problem is that the threshold between a food dose and a medicinal dose is not defined. So we have to demonstrate that one dose of 'medicine' contains no more of the herb than would typically be added to a meal/drink. Herbs like Garlic, Chamomile, Burdock etc are obviously not a problem, but Echinacea is and so are quite a few others. We're also not supposed to make any medicinal claims, but can talk about the nutritional content of a herb and what benefits those nutrients have on the body, from the list of approved claims for vitamins and minerals released in May. If you don't want to go to the massive amount of trouble to do that (and it is VERY time consuming), you can always take the more subtle, educational approach an write articles, hold talks etc not forgetting to mention your web shop. The MHRA are currently using Trading Standards to help enforce these rules, and as says, it's unlikely they're going to be too bothered by us for the forseeable future at least. Good luck, Hannah To: ukherbal-list Sent: Saturday, 16 June 2012, 22:35 Subject: Re: Regulation query Hi Graham,Good to hear you are back!1. The law regarding herbalists making up prescriptions in the UK has not been changed at all. It has never been lawful to supply unlicensed "medicinal products**", except as a herbalist on a one to one basis etc.etc. 2. Fresh legislation regarding retailing "herbal medicinal products**" was introduced recently BUT actually it didn't change the proscriptive bit - it just opened up a possibility of getting such products registered without doing all the clinical trials etc previously required. It was hoped by the regulators that this would clean up the dodgy dealers BUT:there's Regulation; there's Interpretation......... and then there's Enforcement.We all try to interpret the regs - what it means for you and me - but sadly that seems to be irrelevant because (unless your hobby is developing lengthy Legal arguments), what really matters is how the enforcers interpret it. The hint that everyone seemed to miss was that the Enforcement team repeatedly said that they would start 'at the top' - that is dealing with serious miscarriages of herbal medicines law. Hopefully not your or my problem!!It is expected (is this Politics now?) that, in time, the regs will be enforced all the way down, at which point you might think it sensible to consider the niceties of points such as whether the dried Chamomile herb that you might offer on your own particular website is a medicine or a food supplement (how you sell it could be the point). But Law does also have to take into account common usage, so by then, it will all be a bit clearer. There is no clue as to the timescale of any enforcement. It's obviously been affected by budget cuts that weren't in the plan 6 years ago.So, unless you are going to do something blatantly offensive to the law, it seems unlikely that anyone will take any notice. Kind regards Hi All Busy morning for me! The past 3 years have been particularly traumatic for me and I've pretty much dropped out of herbalism completely but (hopefully) things have stabilised and I'm trying to get back into it again. My question is that I have a website (hasn't been updated for at least 4 years!) where I used to sell a small amount of herbs. My understanding is that we can no longer sell unlicenced herbs without a face-to-face consultation, correct? But we can still sell any stock we had when the legislation was introduced (which was when?)? Does the legislation apply to pessaries? If I get an order through the website from outside the EU can I still sell? ThanksGraham White, B.Sc. (Herb. Med.)Medical Herbalist--------------------------------Phone: 01438 213284Mobile: 07740 766335http://www.gcwhite.co.uk/ -- Chenery MNIMH MCPP MSB QPDirector, Rutland Biodynamics Ltd., Organic Medicinal Herb Growers andDepartment of Health (MHRA) Licensed Medicines Manufacturer, Town Park Farm, , Rutland, LE15 8DG, UKEmail: pc@... Website: http://www.rutlandbio.com/Confidentiality: This e-mail and its attachments are intended for the above named only and may be confidential. If they have come to you in error you must take no action based on them, nor must you copy or show them to anyone; please reply to this e-mail and highlight the error. Security Warning: Please note that this e-mail has been created in the knowledge that Internet e-mail is not a 100% secure communications medium. We advise that you understand and observe this lack of security when e-mailing us. Viruses: Although we have taken steps to ensure that this e-mail and attachments are free from any virus, we advise that in keeping with good computing practice the recipient should ensure they are actually virus free. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 20, 2012 Report Share Posted July 20, 2012 Hello Hannah,It's my impression that if possible the MHRA wants to shoe horn as many products into 'medicinal' as possible. I am thinking of expanding to include as many 'nutritional' elements as possible. However I won't put anything up that I'm not sure about. There are lists on the MHRA website etc. However until it hits the fan I'm sure it's going to be hard to tell!If you sail to close to the wind then I'm sure you'll find out sooner or later! It's my impression that Echinacea has been declared always to be medicinal therefore any retail sale would need a THR. Food definitions are pretty tight and obvious, however the gap I see is when nutrients are included as part of the whole etc.It's a minefield! Trying not to get blown up!Lorraine Lorraine Hodgkinson AHG MRCHMHERBS AND HELPERS6, Butts Fold, Cockermouth,Cumbria, CA13 9HY. UK.Tel: +44 (0) 1900 826392Mobile: 07761 489838 (O2)www.herbalmedicineuk.comOn 20 Jul 2012, at 12:06, Hannah Charman wrote: Hello, I know this is an old post but I've only just found it. My understanding is that if you wish to present a strong argument to the MHRA that what you're selling is a food rather than a medicinal herb, you need to have some documentary evidence up your sleeve to that effect. That means you have to prove that the herb you wish to sell, and the dosage you recommend must be in line with how the herb was used as a food within the EU pre May 1997. The problem is that the threshold between a food dose and a medicinal dose is not defined. So we have to demonstrate that one dose of 'medicine' contains no more of the herb than would typically be added to a meal/drink. Herbs like Garlic, Chamomile, Burdock etc are obviously not a problem, but Echinacea is and so are quite a few others. We're also not supposed to make any medicinal claims, but can talk about the nutritional content of a herb and what benefits those nutrients have on the body, from the list of approved claims for vitamins and minerals released in May. If you don't want to go to the massive amount of trouble to do that (and it is VERY time consuming), you can always take the more subtle, educational approach an write articles, hold talks etc not forgetting to mention your web shop. The MHRA are currently using Trading Standards to help enforce these rules, and as says, it's unlikely they're going to be too bothered by us for the forseeable future at least. Good luck, Hannah To: ukherbal-list Sent: Saturday, 16 June 2012, 22:35 Subject: Re: Regulation query Hi Graham,Good to hear you are back!1. The law regarding herbalists making up prescriptions in the UK has not been changed at all. It has never been lawful to supply unlicensed "medicinal products**", except as a herbalist on a one to one basis etc.etc. 2. Fresh legislation regarding retailing "herbal medicinal products**" was introduced recently BUT actually it didn't change the proscriptive bit - it just opened up a possibility of getting such products registered without doing all the clinical trials etc previously required. It was hoped by the regulators that this would clean up the dodgy dealers BUT:there's Regulation; there's Interpretation......... and then there's Enforcement.We all try to interpret the regs - what it means for you and me - but sadly that seems to be irrelevant because (unless your hobby is developing lengthy Legal arguments), what really matters is how the enforcers interpret it. The hint that everyone seemed to miss was that the Enforcement team repeatedly said that they would start 'at the top' - that is dealing with serious miscarriages of herbal medicines law. Hopefully not your or my problem!!It is expected (is this Politics now?) that, in time, the regs will be enforced all the way down, at which point you might think it sensible to consider the niceties of points such as whether the dried Chamomile herb that you might offer on your own particular website is a medicine or a food supplement (how you sell it could be the point). But Law does also have to take into account common usage, so by then, it will all be a bit clearer. There is no clue as to the timescale of any enforcement. It's obviously been affected by budget cuts that weren't in the plan 6 years ago.So, unless you are going to do something blatantly offensive to the law, it seems unlikely that anyone will take any notice. Kind regards Hi All Busy morning for me! The past 3 years have been particularly traumatic for me and I've pretty much dropped out of herbalism completely but (hopefully) things have stabilised and I'm trying to get back into it again. My question is that I have a website (hasn't been updated for at least 4 years!) where I used to sell a small amount of herbs. My understanding is that we can no longer sell unlicenced herbs without a face-to-face consultation, correct? But we can still sell any stock we had when the legislation was introduced (which was when?)? Does the legislation apply to pessaries? If I get an order through the website from outside the EU can I still sell? ThanksGraham White, B.Sc. (Herb. Med.)Medical Herbalist--------------------------------Phone: 01438 213284Mobile: 07740 766335http://www.gcwhite.co.uk/ -- Chenery MNIMH MCPP MSB QPDirector, Rutland Biodynamics Ltd., Organic Medicinal Herb Growers andDepartment of Health (MHRA) Licensed Medicines Manufacturer, Town Park Farm, , Rutland, LE15 8DG, UKEmail: pc@... Website: http://www.rutlandbio.com/Confidentiality: This e-mail and its attachments are intended for the above named only and may be confidential. If they have come to you in error you must take no action based on them, nor must you copy or show them to anyone; please reply to this e-mail and highlight the error. Security Warning: Please note that this e-mail has been created in the knowledge that Internet e-mail is not a 100% secure communications medium. We advise that you understand and observe this lack of security when e-mailing us. Viruses: Although we have taken steps to ensure that this e-mail and attachments are free from any virus, we advise that in keeping with good computing practice the recipient should ensure they are actually virus free. Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.