Medicines (Herbal Remedies Exemptions) (Jersey) Order 1997


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Medicines (Herbal Remedies Exemptions) (Jersey) Order 1997

Official Consolidated Version

This is an official version of consolidated legislation compiled and issued under the authority of the Legislation (Jersey) Law 2021.

 

Showing the law from 1 January 2019 to Current

 

 



Medicines (Herbal Remedies Exemptions) (Jersey) Order 1997[1]

THE HEALTH AND SOCIAL SERVICES COMMITTEE in pursuance of Articles 55, 56 and 110 of the Medicines (Jersey) Law 1995, after consultation with the Medicines Advisory Council and having otherwise complied with Article 110 of the Law, orders as follows –

Commencement [see endnotes]

1        Interpretation

(1)     In this Order, unless the context otherwise requires –

“external use” means application to the skin, hair, teeth, mucosa of the mouth, throat, nose, ear, eye, vagina or anal canal, when a local action only is intended and extensive systemic absorption is unlikely to occur; but does not mean application by means of a throat spray, throat pastille, throat lozenge, throat tablet, nasal drop, nasal spray, nasal inhalation or teething preparation;

“g” means gram;

“herbal remedies” do not include veterinary drugs;

the “Law” means the Medicines (Jersey) Law 1995;

“maximum daily dose” or “MDD” means, in relation to a substance contained in the amount of a medicinal product for internal use, the recommended maximum quantity to be taken or administered in a period of 24 hours;

“maximum dose” or “MD” means, in relation to a substance contained in the amount of a medicinal product for internal use, the recommended maximum quantity to be taken or administered at any one time;

“mg” means milligram.

(2)     For the purposes of this Order, any reference to a substance specified in any Part of the Schedule is a reference to the substance having the common name specified there (being a substance obtained from the botanical source specified in relation to that substance).

(3)     Without prejudice to Article 10 of the Interpretation (Jersey) Law 1954, every provision in the Medicines (Jersey) Law 1995 that relates in any other way to its interpretation shall also apply in the same way to this Order, unless the context otherwise requires.

2        Exemption in Law not to apply to specified herbal remedies

Article 55(1) and (2) of the Law shall not have effect in relation to herbal remedies of any of the following classes –

(a)     herbal remedies that are not medicinal products on a general sale list;

(b)     herbal remedies to which Article 13(2) of the Law does not apply; and

(c)     herbal remedies to which Article 13(2) of the Law does apply, but which contain any of the substances specified in Part 1 or 2 of the Schedule to this Order.

3        Exemption that applies instead in certain cases

(1)     The restrictions in Articles 51 and 52 of the Law shall not apply to the sale by retail, the offer or exposure for sale by retail or the supply in circumstances corresponding to retail sale of any herbal remedy of a class specified in Article 2 of this Order, where the conditions in paragraph (2) of this Article are fulfilled.

(2)     The conditions to which paragraph (1) refers are –

(a)     the herbal remedy does not contain a substance specified in Part 1 of the Schedule;

(b)     if the herbal remedy contains a substance specified in column 1 of Part 3 of the Schedule –

(i)      the herbal remedy is sold or supplied in or from a container or package that is labelled to show a dose not exceeding the maximum dose and not exceeding the maximum daily dose, where specified, in column 2 of that Part in respect of the substance, and

(ii)      if the herbal remedy is for external use only, the percentage of the substance in the herbal remedy does not exceed the percentage, where specified, in column 3 of that Part in respect of the substance;

(c)     the person selling or supplying the herbal remedy has been requested by or on behalf of a particular person, and in that person’s presence, to use his or her own judgment as to the treatment required; and

(d)     the person selling or supplying the herbal remedy has informed the Minister in writing that he or she is selling or supplying or intends to sell or supply herbal remedies to which this Article applies from premises specified in the notice.

4        Further exemption in certain cases

(1)     The restrictions in Articles 51 and 52 of the Law shall not apply to the sale by retail, the offer or exposure for sale by retail or the supply in circumstances corresponding to retail sale of any herbal remedy described in paragraph (2) of this Article, where the conditions in paragraph (3) of this Article are fulfilled.

(2)     Paragraph (1) refers to any herbal remedy of a class specified in Article 2, where the processes to which the plant or plants are subjected –

(a)     consist of drying, crushing or comminution, with or without any subsequent process of tabletting, pill-making, compression or dilution; and

(b)     do not consist of any other process.

(3)     The conditions to which paragraph (1) refers are –

(a)     the herbal remedy does not contain a substance specified in Part 1 or 2 of the Schedule;

(b)     the person selling or supplying the herbal remedy is the occupier of the premises from which it is sold or supplied, and is able to close those premises so as to exclude the public; and

(c)     either –

(i)      the person has informed the Minister in writing that he or she is selling or supplying or intends to sell or supply herbal remedies to which this Article applies from the premises, or

(ii)      the person is the holder of a manufacturer’s licence in respect of the herbal remedy.

5        Power to require further information

(1)     The Minister may serve, on a person selling or supplying or intending to sell or supply any herbal remedy in respect of which an exemption under Article 3 is conferred, a notice in writing requiring the person to furnish to the Minister within a time specified in the notice a list of the substances contained in the herbal remedy.

(2)     Notwithstanding Article 3, where the Minister serves a notice under paragraph (1) and the notice is not complied with, within the time specified in it, the exemption shall cease to have effect until the notice is complied with.

6        Citation

This Order may be cited as the Medicines (Herbal Remedies Exemptions) (Jersey) Order 1997.


SCHEDULE

(Articles 1(2), 2(c), 3(2)(a) and 4(3)(a))

PART 1

Substances in respect of which exemptions for herbal remedies do not apply

Common Name

Botanical Source

Areca

Areca catechu

Canadian hemp

Apocynum cannabinum

Catha

Catha edulis

Chenopodium

Chenopodium ambrosioides var anthelminticum

Crotalaria fulva

Crotalaria berberoana

Crotalaria spect.

Crotalaria spectabilis

Cucurbita

Cucurbita maxima

Duboisia

Duboisia myoporoides

 

Duboisia leichardtii

Elaterium

Ecballium elaterium

Embelia

Embelia ribes

 

Embelia robusta

Erysimum

Erysimum canescens

Holarrhena

Holarrhena antidysenterica

Kamala

Mallotus philippinensis

Kousso

Brayera anthelmintica

Male fern

Dryopteris filix – mas

Mistletoe berry

Viscum album

Poison ivy

Rhus radicans

Pomegranate bark

Punica granatum

Santonica

Artemisia cina

Savin

Juniperus sabina

Scopolia

Scopolia carniolica

 

Scopolia japonica

Stavesacre seeds

Delphinium staphisagria

Strophanthus

Strophanthus kombe

 

Strophanthus courmonti

 

Strophanthus nicholsoni

 

Strophanthus gratus

 

Strophanthus emini

 

Strophanthus sarmentosus

 

Strophanthus hispidus

Slippery elm bark

Ulmus fulva

(whole or unpowdered)

Ulmus rubra

Yohimbe bark

Pausinystalia yohimbe

 


PART 2

(Articles 1(2), 2(c) and 4(3)(a))

Substances in respect of which exemptions for herbal remedies are restricted

Common Name

Botanical Source

Aconite

Aconitum napellus

 

Aconitum stoerkianum

 

Aconitum uncinatum var japonicum

 

Aconitum deinorrhizum

 

Aconitum balfourii

 

Aconitum chasmanthum

 

Aconitum spicatum

 

Aconitum lycoctonum

Adonis vernalis

Adonis vernalis

Belladonna herb

Atropa belladonna

 

Atropa acuminata

Belladonna root

Atropa belladonna

 

Atropa acuminata

Celandine

Chelidonium majus

Cinchona bark

Cinchona calisaya

 

Cinchona ledgerana

 

Cinchona officinalis

 

Cinchona succirubra

 

Cinchona micrantha

Colchium corm

Colchium autumnale

Conium leaf

Conium maculatum

Conium fruits

Conium maculatum

Convallaria

Convallaria majalis

Ephedra

Ephedra sinica

 

Ephedra equisetina

 

Ephedra distachya

 

Ephedra intermedia

 

Ephedra gerardiana

Gelsemium

Gelsemium sempervirens

Hyoscyamus

Hyoscyamus niger

 

Hyoscyamus albus

 

Hyoscyamus muticus

Jaborandi

Pilocarpus jaborandi

 

Pilocarpus microphyllus

Lobelia

Lobelia inflata

Poison oak

Rhus toxicodendron

Quebracho

Aspidosperma quebracho-blanco

Ragwort

Senecio jacobaea

Stramonium

Datura stramonium

 

Datura innoxia

PART 3

(Articles 1(2) and 3(2)(b))

Substances in respect of which exemption for herbal remedies is conditional on labelling and strength

 

Column 1

 

Column 2

Column 3

 

 

Substance

 

Maximum dose and maximum daily dose

Percentage

 

(Common Name)

(Botanical Source)

 

 

 

 

 

Aconite

Aconitum napellus

}

 

 

 

 

Aconitum stoerkianum

}

 

 

 

 

Aconitum uncinatum var japonicum

}

 

 

 

 

Aconitum deinorrhizum

}

 

1.3%

 

 

Aconitum balfourii

}

 

 

 

 

Aconitum chasmanthum

}

 

 

 

 

Aconitum spicatum

}

 

 

 

 

Aconitum lycoctonum

}

 

 

 

 

 

 

 

 

 

Adonis vernalis

Adonis vernalis

 

100 mg (MD)

300 mg (MDD)

 

 

 

 

 

 

 

 

Belladonna Herb

Atropa belladonna

Atropa acuminata

}

}

50 mg (MD)

150 mg (MDD)

 

 

 

 

 

 

 

 

Belladonna Root

Atropa belladonna

Atropa acuminata

}

}

30 mg (MD)

90 mg (MDD)

 

 

 

 

 

 

 

 

Celandine

Chelidonium majus

 

2 g (MD)

6 g (MDD)

 

 

 

 

 

 

 

 

Cinchona bark

Cinchona calisaya

Cinchona ledgerana

Cinchona officinalis

Cinchona succirubra

Cinchona micrantha

}

}

}

}

}

 

250 mg (MD)

750 mg (MDD)

 

 

 

 

 

 

 

 

 

Colchium corm

Colchium autumnale

 

100 mg (MD)

300 mg (MDD)

 

 

 

 

 

 

 

 

Conium leaf

Conium maculatum

 

 

7.0%

 

Conium fruits

Conium maculatum

 

 

7.0%

 

 

 

 

 

 

 

Convallaria

Convallaria majalis

 

150 mg (MD)

450 mg (MDD)

 

 

 

 

 

 

 

 

Ephedra

Ephedra sinica

}

 

 

 

 

Ephedra equisetina

}

 

 

 

 

Ephedra distachya

}

600 mg (MD)

 

 

 

Ephedra intermedia

}

1800 mg (MDD)

 

 

 

Ephedra gerardiana

}

 

 

 

 

 

 

 

 

 

Gelsemium

Gelsemium sempervirens

 

25 mg (MD)

75 mg (MDD)

 

 

 

 

 

 

 

 

Hyoscyamus

Hyoscyamus niger

}

 

 

 

 

Hyoscyamus albus

}

100 mg (MD)

 

 

 

Hyoscyamus muticus

}

300 mg (MDD)

 

 

 

 

 

 

 

 

Jaborandi

Pilocarpus jaborandi

Pilocarpus microphyllus

}

}

 

5.0%

 

 

 

 

 

 

 

Lobelia

Lobelia inflata

 

200 mg (MD)

600 mg (MDD)

 

 

 

 

 

 

 

 

Poison oak

Rhus toxicodendron

 

 

10.0%

 

 

 

 

 

 

 

Quebracho

Aspidosperma quebracho-blanco

 

50 mg (MD)

150 mg (MDD)

 

 

 

 

 

 

 

 

Ragwort

Senecio jacobaea

 

 

10.0%

 

 

 

 

 

 

 

Stramonium

Datura stramonium

Datura innoxia

}

}

50 mg (MD)

150 mg (MDD)

 

 

 

 

 

 

 

 

 

 

 

 

 


Endnotes

Table of Legislation History

Legislation

Year and No

Commencement

Medicines (Herbal Remedies Exemptions) (Jersey) Order 1997

R&O.9134

1 January 1998

States of Jersey (Amendments and Construction Provisions No. 5) (Jersey) Regulations 2005

R&O.45/2005

9 December 2005

Table of Renumbered Provisions

Original

Current

SCHEDULE

SCHEDULE

                PART I

                PART 1

                PART II

                PART 2

                PART III

                PART 3

Table of Endnote References



[1]                                     This Order has been amended by the States of Jersey (Amendments and Construction Provisions No. 5) (Jersey) Regulations 2005. The amendments replace all references to a Committee of the States of Jersey with a reference to a Minister of the States of Jersey, and remove and add defined terms appropriately, consequentially upon the move from a committee system of government to a ministerial system of government


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