Legal Requirements in Herbal Medicine .
Technical and Legal notes
Technical and Legal notes
The Legal Requirements for the Herbal Medicine Sector + and with our clients, the information is updated on a weekly basis.
As of midnight 30/04/2014……… unlicensed herbal or “finished” products can no longer be sold by shop outlets, to the general public. Now they can only sell THR licensed or authorised products.
The Human Medicine Regulation 2012 states: that a Qualified Medical Herbalist (who is properly insured), is only allowed to make herbal preparations or give advice after a Herbal consultation, they cannot have a primary herbal consultation by telephone or web-cam, the consultation MUST be in person. If a person under 18 is to be seen, they must be accompanied by a “responsible” adult. A Qualified Medical Herbalist is allowed to supply clients’ preparations made from medical herbalist stock such as; tinctures, glycerols, creams, ointments, carrier or infused oils, essiential oils, plant materials, herbal extracts, herbal powders in capsules or dried herbs, etc.
But, Repeat preparations can be ordered by telephone communication with the medical herbalist……because we have your records.
The correct proper way is to become a client and get the right preparations, from a qualified medical herbalist, but it can be a good idea to check out the QUALIFIED person with the REGISTRATION BODY- eg, College of Phytotherapy Practitioners, etc + check if they are insured, because if anything goes wrong……………….
But, THR Licensed products can be sold without a consultation in the UK.
UPDATE Any Herbal product that contains Pyrrolizidine Alkoloids MUST BE LABELLED “For External Use Only” + the maximum allowed for PA’s stated by the MHRA, is 0.35?g daily. We have only use PA’s externally, because of damage to health. The only herb we have used is Comfrey (Symphytum off), which we still use in External ointments only, and make sure that our clients understand why we do this. We only purchase dried herbs from companies we can trust, we prefer the Organic Herb Trading Company, as their herbs are really reliable and the best quality.
Never ingest any Senecio jacobaea- (Ragwort ) as it is extremely toxic, and has been implicated in contamination of other herbal products, when weeds in a harvesting area.
The Human Medicine Regulation 2012, has superseded the Medicine Act 1968, the old Regulation 12.2 has now gone with ” herbal medicines exempt from licensing ” after a 7 year transitional period. Now products sold over the counter must be Authorised and have a THMR Licence. Covered by PART 7, starting Regulation 125 of the Human Medicine Regulation 2012.
So FROM 30th APRIL 2014, ALL MANUFACTURED HERBAL MEDICINES WILL HAVE TO BE AUTHORISED IN ORDER TO BE SOLD AND BE SUPPLIED LAWFULLY IN THE UK, thereby conforming to the 2012 Human Medicine Regulation. This means that after the 30 April 2014, HERBAL RETAILERS will no longer be able to sell “unlicensed Herbal Medicines or finished products” that are not registered under the Traditional Herbal Registration Scheme in the UK..
From the 30/04/2014, Qualified Medical Herbalists work under the Human Medicine Regulation 2012 PART 1- Regulation 3 (2) (6) (9).They are only allowed to provide preparations after a 1 to 1 Herbal consultation legally carried out, made from BASIC MEDICINAL HERBALIST STOCK. Made at the practitioner’s premises, where the general public can be excluded.
The old Shedule III is now replaced with Schedule 20.Regulation 241, with Regulation list 1 & 2. Full information in Human Medicine Regulations 2012.
Definition of Basic Medicinal Herbalist Stock. (Part 1 Regulation 2 (a)(b)(i)(ii) and Part 1. Regulation 8 (1) should be noted). The basic components used to make up a preparation, which includes;- Herbal Tinctures,Section 20.Regulation 241, – plant tinctures or plant material,Glycerols, Plant extracts and Secretions. Concentrates, Aromatic waters, Plant materials, Dried or fresh herbs, Herbal Powders, Carrier Seed Oils, Infused oils, Essential oils, Creams or Ointments (we build our own), Emulsifiers, Waxes and Preservative components and other requirements for cream or ointment making., etc. This is to be able to legally fullfil the actions of being a Qualified Medical Herbalist, BUT the sale of unlicensed “finished” products becomes prohibited as of 30th April 2014, this incudes unlicensed tablets, etc.
Also there are herbal plant materials that are restricted or banned from use in the UK, that cannot be used by herbal practitioners, these are listed in the Human Medicine Regulations 2012.
Cosmetic products – As of the 11th July 2013 cosmetic products must be tested to ;-
PET: full challenge test, EU Regulation1223/2009, Have a FULL SAFETY ASSESSMENT carried out by an Independent Assessor and also have TVC batch testing to comply with the lastest regulations.
The False Medicine Directive came into force on or around the 20th April 2013, the directive was introduced by the EU to stop dodgy or fake medicines sales within the EU area and should be considered a good move. Another thought , If you purchase products on the internet that are fake , dangerous or dodgy, getting legal redress or your money back , could be very hard to do, as the those involved “sites” can hide behind dodgy names and servers.
Advertising Standards Authority – Cap code, STOPS any practitioner from making any unsubstanstiated claims, but allows them to make claims about specific conditions allowed by the ASA (see my update note on herbal consultation page). This will stop “dodgy” misinformation and bad practice. It also stops advertisers and web-sites(within the EU) from making claims that are not honest or true. Also claims cannot be made about unlicensed herbs. Clinical studies and double – blind trial information can be offered BUT full data and information must appear.
The Medicines & Healthcare Products Regulatory Agency(MHRA), is responsible for standards of safety and quality of products within the UK. The agency have control over all medical products in use in the UK, including Herbalism and Homoeopathy. The Agency is pro – active in protecting the general public, their web site is full of very useful information, REGULATORY INFORMATION, PROBLEM ISSUES + RECOMMENDATION UPDATES.. + DRUG SAFETY UPDATE…………we find the site very useful, especially for up to date information within the Industry. The free update service is really good, it ‘s worth signing up, to be up to date………………..and know……We find them very helpful, they are usually able to answer any questions we have.
The MHRA has now moved to become part of the GOV.UK web-site, the link on the About us page.
Also the STATUTORY INSTRUMENT 1916 ,The Human Medicine Regulation 2012 can be downloaded as a PDF file , from the MHRA web site.