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List of Herbal Ingredients Which Are Prohibited or Restricted in Medicines

This document provides a consolidated list of herbal ingredients that are prohibited or restricted in medicines according to UK law. It outlines several legal provisions that restrict certain herbs to only being available by prescription, sold in registered pharmacies, or prohibited altogether due to safety concerns. The list then provides the common and botanical names of over 50 herbs, the relevant legal restrictions that apply, and any permitted maximum doses if internal use is allowed. The document is intended to help manufacturers comply with legal restrictions on herbal ingredients in medicines in the UK.

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0% found this document useful (0 votes)
409 views12 pages

List of Herbal Ingredients Which Are Prohibited or Restricted in Medicines

This document provides a consolidated list of herbal ingredients that are prohibited or restricted in medicines according to UK law. It outlines several legal provisions that restrict certain herbs to only being available by prescription, sold in registered pharmacies, or prohibited altogether due to safety concerns. The list then provides the common and botanical names of over 50 herbs, the relevant legal restrictions that apply, and any permitted maximum doses if internal use is allowed. The document is intended to help manufacturers comply with legal restrictions on herbal ingredients in medicines in the UK.

Uploaded by

Etra Publishing
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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LIST OF HERBAL INGREDIENTS WHICH ARE PROHIBITED OR RESTRICTED IN MEDICINES

The table below provides, for convenience, a consolidated and alphabetical list of herbal ingredients which are subject to various restrictions. Some herbal
ingredients are subject to more than one set of restrictions. The Medicines and Healthcare products Regulatory Agency (MHRA) has made every effort to ensure
that the information contained within this document is correct. It is, however, the responsibility of manufacturers, wholesale dealers, importers and anyone
placing medicinal products on the market to ensure that they comply with the law. The Agency does not accept liability for any inaccuracies contained within this
document or the absence of any information. This document is intended as guidance only and does not supersede the individual legal provisions covered by it.
LEGAL PROVISION MAIN EFFECT
The Medicines (Aristolochia and Mu Tong etc.) Not permissible to manufacture, import, sell or supply any unlicensed medicine in the UK which
(Prohibition) Order 2001 SI 1841 contains the named herbal ingredients.
(See Annex 1 which explains in more detail the provisions relating to all Aristolochia and
ingredients at risk of confusion with Aristolochia species)
The Prescription Only Medicines (Human Use) Order Prescription only medicines (POMs) can only be made available via a prescription from a registered doctor or
19971 1SI 1830 dentist.
The Medicines (Retail Sale or Supply of Herbal Prohibits the sale or supply (including general retail or following a one-to-one consultation with a
Remedies) Order 1977 practitioner) of herbal medicines in the UK if it contains one or more of the listed plants, except
SI 2130 – Part I where sold in premises which are registered pharmacies and by or under the supervision of a
pharmacist.

The Medicines (Retail Sale or Supply of Herbal Plants listed in Part II of SI 2130 can only be sold in herbal medicines following a one-to-one
Remedies) Order 1977 SI 2130 – Part II & III consultation with a practitioner, at the dosages and by the route of administration specified in Part
III. If the dosage specified is exceeded or if the route of administration differs from that specified,
the herbal medicines containing these plants can only be supplied in premises which are registered
pharmacies and by or under the supervision of a pharmacist

The Medicines for Human Use (Kava-kava) Prohibits the sale, supply and importation of unlicensed medicines containing Kava-kava, except
(Prohibition) Order 2002 SI 3170 those for external use only.

The Medicines for Human Use (Prohibition) Senecio and Prohibits the sale, supply and importation of any medicinal product consisting of or containing Senecio
Miscellaneous Amendments Order 2008

1 1
(SI 1997/1830), updated in line with the subsequent amendment Orders (SI 1997/2044; SI 1998/108; SI 1998/1178; SI 1998/2081; SI 1999/1044; SI 1999/3463; SI 2000/1917; SI
2000/2899; SI 2000/3231)
Maximum dose where permitted:
FOR INTERNAL USE FOR EXTERNAL USE
Botanical source Common name Legal category ONLY ONLY
Max dose (MD)2, max Percentage (%)
daily dose (MDD)3
All Aconitum species
including:
Aconitum napellus
Aconitum stoerkianum No permitted dose unless
Aconitum uncinatum var POM and made available by a
Aconite 1.3 % or below
japonicum prescription from a
Aconitum deinorrhizum SI 2130 – Parts II & III registered doctor or
Aconitum balfourni dentist.
Aconitum chasmanthum
Aconitum spicatum
Aconitum lycoctonum
Adonis vernalis 100 mg (MD), 300 mg
Adonis vernalis SI 2130 – Parts II & III No dose permitted
(MDD)
Akebia quinata
Mu tong SI 1841 Prohibited in all unlicensed medicines
Akebia trifoliata

Can only be sold in premises which are registered


Apocynum cannabinium Canadian Hemp SI 2130 – Part I
pharmacies and by or under the supervision of a pharmacist

2
‘Maximum dose’ or ‘MD’ means the maximum quantity of the substance contained in the amount of the medicinal product for internal use which it is recommended should be taken or administered at
any one time
3
Maximum daily dose’ or ‘MDD’ means the maximum quantity of the substance contained in the amount of the medicinal product for internal use which it is recommended should be taken or
administered in any period of 24 hours
Maximum dose where permitted:
FOR INTERNAL USE FOR EXTERNAL USE
Botanical source Common name Legal category ONLY ONLY
Max dose (MD)2, max Percentage (%)
daily dose (MDD)3
Can only be sold in premises which are registered
Areca catechu Areca SI 2130 – Part I
pharmacies and by or under the supervision of a pharmacist
Aristolochia
Aristolochia clematis
Mu tong; Fangji;
Aristolochia contorta
Birthwort; Long No permitted dose unless made available by a prescription
Aristolochia debelis POM
Birthwort; Indian from a registered doctor or dentist.
Aristolochia fang-chi
Birthwort
Aristolochia manshuriensis
Aristolochia serpentaria
Aristolochia
Aristolochia clematis
Mu tong; Fangji;
Aristolochia contorta
Birthwort; Long
Aristolochia debelis SI 1841 Prohibited in all unlicensed medicines
Birthwort; Indian
Aristolochia fang-chi
Birthwort
Aristolochia manshuriensis
Aristolochia serpentaria

Can only be sold in premises which are registered


Artemisia cina Santonica SI 2130 – Part I
pharmacies and by or under the supervision of a pharmacist

Belladonna herb SI 2130- Parts II & III Can only be sold in premises
Atropa belladonna - herb 50 mg (MD), 150 mg which are registered pharmacies
Atropa acuminata - herb (MDD) and by or under the supervision
of a pharmacist
Maximum dose where permitted:
FOR INTERNAL USE FOR EXTERNAL USE
Botanical source Common name Legal category ONLY ONLY
Max dose (MD)2, max Percentage (%)
daily dose (MDD)3
Atropa belladonna - root Can only be sold in premises
Atropa acuminata – root which are registered
30 mg (MD), 90 mg
Belladonna root SI 2130 – Parts II & III pharmacies and by or under
(MDD)
the supervision of a
pharmacist
Can only be sold in premises
which are registered
Aspidosperma quebracho- 50 mg (MD), 150 mg
Quebracho SI 2130- Part II & III pharmacies and by or under
blanco (MDD)
the supervision of a
pharmacist

Can only be sold in premises which are registered


Brayera anthelmintica Kousso SI 2130 – Part I
pharmacies and by or under the supervision of a pharmacist

Can only be sold in premises which are registered


Catha edulis Catha SI 2130 – Part I
pharmacies and by or under the supervision of a pharmacist
Can only be sold in premises
which are registered
Chelidonium majus Celandine SI 2130 –Part II & III 2 g (MD), 6 g (MDD) pharmacies and by or under
the supervision of a
pharmacist

Chenopodium ambrosioides var Can only be sold in premises which are registered
Chenopodium SI 2130 – Part I
anthelminticum pharmacies and by or under the supervision of a pharmacist
Maximum dose where permitted:
FOR INTERNAL USE FOR EXTERNAL USE
Botanical source Common name Legal category ONLY ONLY
Max dose (MD)2, max Percentage (%)
daily dose (MDD)3
Cinchona calisaya Can only be sold in premises
Cinchona ledgerana which are registered
250 mg (MD), 750 mg
Cinchona officinalis Cinchona bark SI 2130 – Part II & III pharmacies and by or under
(MDD)
Cinchona succirubra the supervision of a
Cinchona micrantha pharmacist
Clematis armandii
Mu tong SI 1841 Not permitted in any unlicensed medicines
Clematis montana
Claviceps purpurea Ergot, prepared Ergot POM Can only be made available by a prescription from a
of Rye; Smut of Rye; registered doctor or dentist.
Spurred Rye;
Can only be made available by a prescription from a
Cocculus indicus POM
registered doctor or dentist.
Cocculus laurifolius
Cocculus orbiculatus Fangji SI 1841 Not permitted in any unlicensed medicines
Cocculus trilobus
Can only be sold in premises
which are registered
100 mg (MD), 300 mg
Colchicum autumnale Colchicum corm SI 2130 – Part II & III pharmacies and by or under
(MDD)
the supervision of a
pharmacist
No permitted dose unless
made available by a
POM and SI 2130 – Parts II
Conium maculatum Conium leaf and fruits prescription from a 7.0 % or below
& III
registered doctor or
dentist.
Maximum dose where permitted:
FOR INTERNAL USE
FOR EXTERNAL USE ONLY
Botanical source Common name Legal category ONLY
Max dose (MD)2, max daily Percentage (%)
dose (MDD)3
Can only be sold in premises which
SI 2130-Parts II & 150 mg (MD), 450 mg
Convallaria majalis Convallaria are registered pharmacies and by or
III (MDD)
under the supervision of a pharmacist
Can only be sold in premises which are registered pharmacies and by
Crotalaria berberoana Crotalaria fulva 2130 – Part I
or under the supervision of a pharmacist

Can only be sold in premises which are registered pharmacies and by


Crotalaria spectabilis Crotalaria spect SI 2130 – Part I
or under the supervision of a pharmacist

Can only be sold in premises which are registered pharmacies and by


Curcurbita maxima Cucurbita SI 2130 – Part I
or under the supervision of a pharmacist
Can only be sold in premises which
Datura stramonium SI 2130- Parts II &
Stramonium 50 mg (MD), 150 mg (MDD) are registered pharmacies and by or
Datura innoxia III
under the supervision of a pharmacist
Can only be sold in premises which are registered pharmacies and by
Delphinium staphisagria Stavesacre seeds SI 2130 – Part I
or under the supervision of a pharmacist

Digitalis leaf POM Can only be made available via a prescription from a registered doctor
Foxglove
Digitalis prepared or dentist.
Can only be sold in premises which are registered pharmacies and by
Dryopteris filix-mas Male fern SI 2130 – Part I
or under the supervision of a pharmacist
Duboisia myoporoides Duboisia SI 2130 – Part I Can only be sold in premises which are registered
Duboisia leichardtii pharmacies and by or under the supervision of a pharmacist
Maximum dose where permitted:

FOR INTERNAL USE ONLY FOR EXTERNAL USE ONLY


Botanical source Common name Legal category
Max dose (MD)2, max daily Percentage (%)
dose (MDD)3
Can only be sold in premises which are registered pharmacies and by
Ecballium elaterium Elaterium SI 2130 – Part I
or under the supervision of a pharmacist
Embelia ribes Embelia SI 2130 – Part I Can only be sold in premises which are registered
Embelia robusta pharmacies and by or under the supervision of a pharmacist
Ephedra sinica Ephedra
Can only be sold in premises which
equisetina Ephedra
SI 2130 – Parts II & are registered pharmacies and by or
distachya Ephedra Ephedra 600 mg (MD), 1800 mg (MDD)
III under the supervision of a
intermedia Ephedra
pharmacist
gerardiana
Can only be sold in premises which are registered pharmacies and by
Erysimum canescens Erysimum SI 2130 – Part I
or under the supervision of a pharmacist
SI 2130 – Parts II & Can only be sold in premises which
III are registered pharmacies and by or
Gelsemium sempervirens Gelsemium 25 mg (MD), 75 mg (MDD)
under the supervision of a
pharmacist

Holarrhena Can only be sold in premises which are registered pharmacies and by
Holarrhena SI 2130 – Part I
antidysenterica or under the supervision of a pharmacist
Maximum dose where permitted:
FOR INTERNAL USE FOR EXTERNAL USE
Botanical source Common name Legal category ONLY ONLY
Max dose (MD)2, max Percentage (%)
daily dose (MDD)3
Can only be sold in
Hyoscyamus niger premises which are
100 mg (MD), 300 mg
Hyoscyamus albus Hyoscyamus SI 2130 – Parts II & III registered pharmacies and
(MDD)
Hyoscyamus muticus by or under the supervision
of a pharmacist
Juniperus sabina Savin SI 2130 – Part I Can only be sold in premises which are registered
pharmacies and by or under the supervision of a
pharmacist
Can only be sold in
premises which are
200 mg (MD), 600 registered pharmacies and
Lobelia inflata Lobelia SI 2130 –Parts II & III
(MDD) by or under the
supervision of a
pharmacist
Can only be sold in premises which are registered
Mallotus philippinensis Kamala SI 2130 – Part I pharmacies and by or under the supervision of a
pharmacist

Can only be made available via a prescription from a


Mandragora autumnalis Mandrake POM
registered doctor or dentist.

Can only be made available via a prescription from a


Papaver somniterum Poppy capsule POM
registered doctor or dentist.
Maximum dose where permitted:
FOR INTERNAL USE FOR EXTERNAL USE
Botanical source Common name Legal category ONLY ONLY
Max dose (MD)2, max Percentage (%)
daily dose (MDD)3
Can only be sold in premises which are registered
Pausinystalia yohimbe Yohimbe bark SI 2130 – Part 1 pharmacies and by or under the supervision of a
pharmacist
Can only be sold in
premises which are
Pilocarpus jaborandi registered pharmacies and
Jaborandi SI 2130- Parts II & III 5.0 % or below
Pilocarpus microphyllus by or under the
supervision of a
pharmacist.
Not permitted in unlicensed medicines, except those
Piper methysticum Kava-kava SI 3170
exclusively for external use.
May Apple; Devil’s POM
Can only be made available via a prescription from a
Podophyllum Apple; Wild Lemon;
registered doctor or dentist.
Indian Podophyllum
Podophyllum indian May Apple; Devil’s POM
Apple; Wild Lemon; Can only be made available via a prescription from a
Indian Podophyllum registered doctor or dentist.
Maximum dose where permitted:
FOR INTERNAL USE FOR EXTERNAL USE
Botanical source Common name Legal category ONLY ONLY
Max dose (MD)2, max Percentage (%)
daily dose (MDD)3
May Apple; Devil’s Can only be made
Apple; Wild Lemon; available via a
Podophyllum resin Indian Podophyllum POM prescription from a 20 % or below
registered doctor, nurse or
dentist.
Can only be sold in premises which are registered
Punica granatum Pomegranate Bark SI 2130 – Part I
pharmacies and by or under the supervision of a pharmacist
Rauwolfia;
Can only be made available via a prescription from a
Rauwolfia serpentina serpentwood; Indian POM
registered doctor or dentist.
snakeroot
Can only be made available via a prescription from a
Rauwolfia vomitoria African serpentwood POM
registered doctor or dentist.

Can only be sold in premises which are registered


Rhus radicans Poison Ivy SI 2130 – Part I
pharmacies and by or under the supervision of a pharmacist
Can only be sold in 10.0 % or below
premises which are
Rhus toxicodendron Poison Oak SI 2130 – Parts II & II registered pharmacies and
by or under the supervision
of a pharmacist.
Maximum dose where permitted:
FOR INTERNAL USE FOR EXTERNAL USE
Botanical source Common name Legal category ONLY ONLY
Max dose (MD)2, max daily Percentage (%)
dose (MDD)3

Can only be made available via a prescription from a


Schoenocaulon officinale Sabadilla; Cevadilla POM
registered doctor or dentist.
Scopolia carniolica Scopolia SI 2130 – Part I Can only be sold in premises which are registered
Scopolia japonica pharmacies and by or under the supervision of a pharmacist
Senecio Ragwort; Groundsel SI 548 Not permitted in any unlicensed medicines
Not permitted in any unlicensed medicines
Stephania tetrandra Fangji SI 1841
Strophanthus kombe
Strophanthus courmonti
Strophanthus nicholsoni Strophanthus SI 2130 – Part I
Can only be sold in premises which are registered
Strophanthus gratus
pharmacies and by or under the supervision of a pharmacist
Strophanthus emini
Strophanthus sarmentosus
Strophanthus hispidus
Can only be made available via a prescription from a
Strychnos ignatii; S. cuspida Ignatius bean POM
registered doctor or dentist.
Nux vomica seed; Can only be made available via a prescription from a
Strychnos nux vomica seed POM
Poison Nut registered doctor or dentist.
Maximum dose where permitted:
FOR EXTERNAL USE
Botanical source Common name Legal category ONLY Percentage (%)
FOR INTERNAL USE
ONLY Max dose (MD)2,
max daily dose (MDD)3
Slippery Elm Bark
Ulmus fulva Can only be sold in premises which are registered
(whole or SI 2130 – Part I
Ulmus rubra pharmacies and by or under the supervision of a pharmacist
unpowdered)
Veratrum viride Hellebore American; POM Can only be made available via a prescription from a
Green Hellebore; registered doctor or dentist.
American Veratrum;
Indian Poke
Can only be made available via a prescription from a
Veratrum album White Hellebore POM
registered doctor or dentist.
Can only be sold in premises which are registered
Viscum album Mistletoe berry SI 2130 – Part I pharmacies and by or under the supervision of a pharmacist

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