Legal Requirements in Herbal Medicine .

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The Human Medicine Regulation 2012, has superseded the Medicine Act 1968, the old Regulation 12.2 has now gone with ” herbal medicines exempt from licensing ” after a 7 year transitional  period.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.


    • NO  EFFICACY CLAIMS CAN BE MADE ABOUT ANY FOOD PRODUCT, within the EU, so if you are offered a food product with any claims, you know it is a breach of the Regulation. There are a few  exceptions, there are certain food products that have a world wide patent and are classed as food with medical uses, and carry the relevant information on the packaging.
    • While we are on the food subject. There are food products, that contain contaminants that are not listed, which can cause allergy problems. This is a breach of food regulations.               Another case to consider, we were sold what I thought was a herbal powder, when it arrived there was a label on the front stating “packed in a factory that handles celery, mustard and sesame”……So I am being told that it could be contaminated with those materials. We refuse to deal with the company any longer (we thought the company supplied medical herbal grade powders), as we do not wish to use possibly contaminated  herbal powders, the product was destroyed.  THREE things come to mind, Is the product produced in a clean area and was the company involved trying to somewhat pass the buck on, WAS THE POSSIBLE ALLERGY ISSUE BEING PASSED TO US, TO DEAL WITH. And was the company a herbal supplier or food  material supplier? BEAR THIS IN MIND WHEN ORDERING……………….


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.