Medicines (Pharmacy
and General Sale Exemptions) (Jersey) Order 1997
THE HEALTH AND SOCIAL SERVICES COMMITTEE in pursuance of Articles 54, 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 –
“controlled drug”
has the same meaning as it has in Article 3 of the Misuse of Drugs (Jersey)
Law 1978;
“cosmetic”
means any substance or preparation –
(a) that
is intended to be applied to any one or more of the various surfaces of the
human body, including the skin, pilary system and hair, nails, lips and
external genital organs, and the teeth and buccal mucosa; and
(b) is so
intended wholly or mainly for the purpose of perfuming them, cleansing them,
protecting them, caring for them or keeping them in condition, modifying their
appearance (whether for aesthetic purposes or otherwise) or combating body
odours or normal body perspiration;
“enrolled dental
hygienist” means a person who is enrolled as a dental hygienist under the
Ancillary Dental Workers (Jersey) Regulations 1974;
“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;
“food”
includes –
(a) beverages
and confectionery;
(b) substances
and articles used as ingredients in the preparation of food; and
(c) any
manufactured substance to which there has been added any vitamin and which is
advertised as being available and for sale to the general public as a dietary
supplement;
“Law” means the Medicines (Jersey)
Law 1995;
“master” has
the same meaning as it has in the Merchant Shipping Act 1894 of the United
Kingdom;
“medicinal product”
does not include a veterinary drug;
“occupational health
scheme” means a scheme in which a person in the course of a business
carried on by the person provides facilities, for the person’s employees,
for the treatment or prevention of disease;
“operator”, in
relation to an aircraft, means the person for the time being having the
management of the aircraft;
“parenteral
administration” means administration by breach of the skin or mucous
membrane;
“pharmacy medicine”
means a medicinal product that is not –
(a) a
prescription only medicine; or
(b) a
medicinal product on a general sale list;
“pre-school dental
scheme” means a scheme supervised by a doctor or dentist in which
medicinal products are supplied to parents or guardians of children under 5,
for use for the purpose of preventing dental caries in such children;
“prescription only
medicine” has the same meaning as it has in Article 1(1) of the Medicines (Prescription
Only) (Jersey) Order 1997;
“registered
chiropodist” means a person who is registered as a chiropodist under the Health Care
(Registration) (Jersey) Law 1995;
“registered optometrist”
has the same meaning as it has in Article 1(1) of the Opticians (Registration)
(Jersey) Law 1962;
“sale”
includes an offer for sale and exposure for sale;
“school dental
scheme” means a scheme supervised by a doctor or dentist in which
medicinal products are supplied at a school, to pupils of that school, for the
purpose of preventing dental caries;
“supply” means
supply in circumstances corresponding to retail sale;
“unit preparation”
means a preparation (including a mother tincture) that is prepared by a process
of solution, extraction or trituration, with a view to being diluted tenfold or
one hundredfold (either once or repeatedly) in an inert diluent and then used
either in that diluted form or (where applicable) by impregnating tablets,
granules, powders or other inert substances for the purpose of being
administered to human beings.[1]
(2) 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 Transitional exemption for sale and supply of products not on
general sale list
(1) The
restrictions in Article 51 of the Law shall not apply, in any case
described in paragraph (2) of this Article, during the period specified in
paragraph (3) of this Article.
(2) Paragraph (1)
of this Article refers to the sale or supply of any medicinal
product –
(a) that
is for use by being administered to human beings; and
(b) in
respect of which a product licence is in effect, containing a provision that,
where the conditions in Article 52(2), (3) and (4) of the Law are
fulfilled, the product may be sold or supplied otherwise than by or under the
supervision of a pharmacist.
(3) The
period to which paragraph (1) refers is –
(a) where
the product licence has been granted with the provision described in paragraph (2)(b),
the period of 2 years following the grant of the licence; and
(b) where
the licence has been varied, after its grant, to include the provision, the
period of one year following the variation.
3 Exemption for certified midwives
For the purposes of Article 54(2)
of the Law the following classes of medicinal product are specified in relation
to certified midwives as classes to which the exemption applies –
(a) medicinal
products that are not prescription only medicines; and
(b) prescription
only medicines that, by virtue of an exemption conferred by an Order made under
Article 57(4) of the Law, may be sold or supplied by a certified midwife
otherwise than in accordance with a prescription given by a person who is an
appropriate practitioner for the purposes of that Article.
4 Exemptions for other categories of persons
(1) The
restrictions in Article 51 of the Law shall not apply –
(a) to
the sale or supply, by any person specified in column 1 of Part 1 of Schedule 1
to this Order; or
(b) to
the supply by any person specified in column 1 of Part 2 of that Schedule,
of the prescription only
medicines and the pharmacy medicines specified in the corresponding paragraph
in column 2 of such Part in relation to that person, where the conditions
specified in the corresponding paragraph in column 3 of such Part are
fulfilled.
(2) The
restrictions in Article 52 of the Law shall not apply to the sale or
supply, by any person specified in column 1 of Part 1 or 2 of Schedule 1
to this Order, of any medicinal product on a general sale list specified in the
corresponding paragraph in column 2 of such Part in relation to that person,
where the conditions in the corresponding paragraph in column 3 of such Part
are fulfilled.
5 Exemptions for highly diluted medicinal products
(1) The
restrictions in Articles 51 and 52 of the Law shall not apply to the sale
or supply of a medicinal product that is not for parenteral administration and
is not a controlled drug, and consists solely of one or more unit
preparations –
(a) of
any substance, where each unit preparation has been diluted to at least one part
in a million (6x);
(b) of
any substance specified in Part 1 of Schedule 2 to this Order, where
each unit preparation has been diluted to at least one part in a thousand (3x);
or
(c) of
any substance –
(i) specified in
column 1 of Table A of Schedule 2 to the Medicines (General Sale
List) (Jersey) Order 1997 or in Part 3 of Schedule 2 to this
Order, or
(ii) specified
(if the medicinal product in question is for external use only) in column 1 of
Table B of Schedule 2 to that Order or in Part 4 of Schedule 2
to this Order,
if (in either case)
each unit preparation has been diluted to at least one part in ten (1x),
where the person selling
or supplying the medicinal product 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.
(2) The
restrictions in Article 51 of the Law shall not apply to the sale or
supply of a medicinal product that is not for parenteral administration and is
not a controlled drug, and consists solely of one or more unit
preparations –
(a) of
any substance, where each unit preparation has been diluted to at least one part
in a million million (6c);
(b) of
any substance specified in Part 2 of Schedule 2 to this Order, where
each unit preparation has been diluted to at least one part in a million (6x);
or
(c) of
any substance –
(i) specified in
column 1 of Table A of Schedule 2 to the Medicines (General Sale
List) (Jersey) Order 1997 or in Part 3 of Schedule 2 to this
Order, or
(ii) specified
(if the medicinal product in question is for external use only) in column 1 of
Table B of Schedule 2 to that Order or in Part 4 of Schedule 2
to this Order,
if (in either case)
each unit preparation has been diluted to at least one part in ten (1x),
where the conditions in Article 52(2),
(3) and (4) of the Law are fulfilled.
6 Exemption for foods and cosmetics
For the purposes of the
sale or supply of any medicinal product on a general sale list that is for sale
either for oral administration as a food or for external use as a cosmetic, Article 52
of the Law shall have effect as if paragraph (2) of that Article had not
been enacted.
7 Citation
This Order may be cited
as the Medicines (Pharmacy and General Sale Exemptions) (Jersey)
Order 1997.
SCHEDULE
1
(Article 4(1) and (2))
Exemptions from Articles 51
and 52 of the Law
PART 1[2]
|
Column 1
|
Column 2
|
Column 3
|
|
Persons exempted
|
Medicinal products
to which the
exemption applies
|
Conditions
|
|
1. Registered chiropodists.
|
1.(1) Medicinal
products on a general sale list that are for external use and are not
veterinary drugs.
|
1.(1) The
sale or supply shall be only in the course of the chiropodist’s
professional practice.
|
|
(2) The following pharmacy medicines for external use –
|
(2) The medicinal product shall have been made up for sale or
supply in a container elsewhere than at the place at which it is sold or
supplied.
|
|
(a) Potassium permanganate crystals or solution;
|
|
(b) ointment of Heparinoid
and Hyaluronidase; and
|
|
(c) products containing, as
their only active ingredients, any of the following substances at a strength
not exceeding that specified in each case –
|
|
9.0% Borotannic complex
|
|
10.0% Buclosamide
|
|
3.0% Chlorquinaldol
|
|
1.0% Clotrimazole
|
|
10.0% Crotamiton
|
|
5.0% Diamthazole hydrochloride
|
|
1.0% Econazole nitrate
|
|
1.0% Fenticlor
|
|
10.0% Glutaraldehyde
|
|
0.4% Hydrargaphen
|
|
2.0% Mepyramine maleate
|
|
2.0% Miconazole nitrate
|
|
2.0% Phenoxypropan-2-0l
|
|
20.0% Podophyllum resin
|
|
10.0% Polynoxylin
|
|
70.0% Pyrogallol
|
|
70.0% Salicylic acid
|
|
0.1% Thiomersal.
|
|
2. Registered optometrists.
|
2.(1) All
medicinal products on a general sale list.
|
2.(1) The
sale or supply shall be only in the course of the optician’s
professional practice.
|
|
(2) All pharmacy medicines.
|
(2) The sale or supply shall be only in an emergency.
|
|
(3) Prescription only medicines (not being for parenteral
administration) that are of any of the following descriptions –
|
|
(a) eye drops that are prescription only medicines by reason
only that they contain not more than –
|
|
|
(i)
|
30.0% Sulphacetamide sodium; or
|
|
|
(ii)
|
0.5% Chloramphenicol; or
|
|
(b) eye ointments that are prescription only medicines by reason
only that they contain not more than –
|
|
|
(i)
|
30.0% Sulphacetamide sodium; or
|
|
|
(ii)
|
1.0% Chloramphenicol; or
|
|
(c) medicinal products that are prescription only medicines by
reason only that they contain any of the following substances –
|
|
Atropine sulphate
|
|
Bethanecol chloride
|
|
Carbachol
|
|
Cyclopentolate hydrochloride
|
|
Homatropine hydrobromide
|
|
Hyoscine hydrobromide
|
|
Naphazoline hydrochloride
|
|
Naphazoline nitrate
|
|
Neostigmine methylsulphate
|
|
Physostigmine salicylate
|
|
Physostigmine sulphate
|
|
Pilocarpine hydrochloride
|
|
Pilocarpine nitrate
|
|
Tropicamide.
|
PART 2
(Article 4(1) and
(2))
|
Column 1
|
Column 2
|
Column 3
|
|
Persons exempted
|
Medicinal products
to which the
exemption applies
|
Conditions
|
|
1.(1) The
Royal National Lifeboat Institution.
(2) Certificated first aiders of the Institution.
|
1. All medicinal products.
|
1. The supply shall be only so far as is necessary for the
treatment of sick or injured persons.
|
|
2.(1) The
St. John Ambulance Association and Brigade.
(2) Certificated first aid and certificated nursing members of
the Association and Brigade.
|
2.(1) All
medicinal products on a general sale list.
(2) All pharmacy medicines.
|
2. The supply shall be only so far as is necessary for the
treatment of sick or injured persons.
|
|
3. The owner or the master of a ship that does not carry a
doctor on board as part of the ship’s complement.
|
3. All medicinal products.
|
3. The supply shall be only so far as is necessary for the
treatment of persons on the ship.
|
|
4.The operator or commander of an aircraft.
|
4.(1) All medicinal products on a general sale list.
(2) All pharmacy medicines.
(3) Prescription only medicines that are not for parenteral
administration and have been sold or supplied to the operator or commander of
the aircraft in response to an order in writing signed by a doctor.
|
4.(1) The supply shall be only so far as is necessary for the
immediate treatment of sick or injured persons on the aircraft.
(2) In the case of a prescription only medicine, the supply
shall be in accordance with the written instructions of a doctor as to the
circumstances in which prescription only medicines of the description in
question are to be used on the aircraft.
|
|
5. Persons operating an occupational health scheme.
|
5.(1) All medicinal products on a general sale list.
(2) All pharmacy medicines.
(3) Such prescription only medicines as are sold or supplied to
a person operating an occupational health scheme in response to an order in
writing signed by a doctor or a registered nurse.
|
5.(1) The supply shall be in the course of an occupational
health scheme.
(2) The person supplying the medicinal product shall be –
(a) a doctor; or
(b) a registered nurse.
(3) Where the person supplying the medicinal product is a
registered nurse and it is a prescription only medicine, the nurse shall be
acting in accordance with the written instructions of a doctor as to the
circumstances in which prescription only medicines of the description in
question are to be used in the course of the scheme.
|
|
6. Persons carrying on the business of a school providing
full-time education.
|
6. Pharmacy medicines that are for use in the prevention of
dental caries and consist of or contain sodium fluoride.
|
6. The supply shall be –
(a) in the course of a school dental scheme; and
(b) if to a child under 16, only where the parent or
guardian of that child has consented to such supply.
|
|
7. The Health and Social Services Department, and any other
department of the States that provides a pre-school dental scheme.
|
7. Pharmacy medicines that are for use in the prevention of
dental caries and consist of or contain sodium fluoride.
|
7. The supply shall be –
(a) in the course of a pre-school dental scheme, in which the
person supplying the medicinal product is a registered nurse or an enrolled
dental hygienist; or
(b) in the course of a school dental scheme and, if to a child
under 16, only where the parent or guardian of that child has consented
to such supply.
|
SCHEDULE 2
Exemptions for highly
diluted medicinal products
PART 1
(Article 5(1)(b))
Unit preparations diluted to at least one part in a thousand (3x)
Agaricus muscarius
Ailanthus glandulosa
Apocynum cannabinum
Aurum iodatum
Belladonna
Bismuth subgallate
Bryonia alba dioica
Calcium fluoride
Cantharis
Cerium oxalicum
Chelidonium majus
Chenopodium oil
Cina
Colocynthis
Convallaria majalis
Gelsemium sempervirens
Hyoscyamus niger
Lycopodium
Manganese acetate
Ranunculus bulbosus
Terebinthinae oleum
Agaricus muscarius
Ailanthus glandulosa
Apocynum cannabinum
Aurum iodatum
Belladonna
Bismuth subgallate
Bryonia alba dioica
Calcium fluoride
Cantharis
Cerium oxalicum
Chelidonium majus
Chenopodium oil
Cina
Colocynthis
Convallaria majalis
Gelsemium sempervirens
Hyoscyamus niger
Lycopodium
Manganese acetate
Ranunculus bulbosus
Terebinthinae oleum
PART 2
(Article 5(2)(b))
Unit preparations diluted to at least one part in a million (6x)
Adonis vernalis
Agaricus bulbosus
Agaricus muscarius
Agnus castus
Ailanthus glandulosa
Alum
Amethyst
Ammonium iodide
Amygdalae amarae
Apatite
Apocynum androsaemifolium
Apocynum cannabinum
Argentite
Argentum chloride
Argentum iodide
Arnica
Artemisia cina
Aspidium anthelmintica
Aspidium filix-mas
Aurum sulphide
Balsamum copaivae
Balsamum peruvianum
Barium citrate
Barium sulphate
Bismuth metal
Bismuth subgallate
Bismuth subnitrate
Boletus laricis
Bovista
Cade oil
Calcium fluoride
Cantharis
Carduus marianus
Cedar wood oil
Cerium oxalicum
Chalcocite
Chalcopyrite
Chelidonium majus
Chenopodium
oil
Colocynthis
Convallaria
majalis
Copper
silicate, nat.
Crotalus
horridus
Cucumis
melo
Cucurbita
Datura
stramonium
Derris
Diamond
Ephedra vulgaris
Ferric acetate
Ferrous iodide
Ferrous oxalate
Ferrous sulphide
Formic acid
Gall
Gelsemium sempervirens
Gneiss
Granatum (Pomegranate bark)
Hamamelis virginiana
Hepar
sulfuris
Hyoscyamus
niger
Iris
florentine
Jaborandi
Juniperus
sabina
Kaolinite
Lachmanthus
tinctoria
Lapis
albus
Lycopodium
Magnesium
Magnesium
acetate
Magnesium
chloride
Magnetite
Manganese
acetate
Nicotiana tabacum
Nicotiana tabacum oil
Oleander
Opuntia
vulgaris
Oxalic
acid
Petroleum
Phellandrum
aquaticum
Pix
liquida
Platinum
Platinum
chloride
Potassium
hydroxide
Potassium
silicate
Pyrethrum
Pyrolusite
Ranunculus
acris
Ranunculus
bulbosus
Ranunculus
flammula
Ranunculus
repens
Ranunculus
sceleratus
Rhodium
oxynitrate
Rhododendron chrysanthemum
Rhus toxicodendron
Salicylic acid
Scrophularia aquatica
Sodium aluminium chloride
Sodium auro-chloride
Sodium hypochlorite
Sodium nitrate
Squill
Stannum metal
Staphisagria
Sulphur iodide
Tamus communis
Tannic acid
Terebinthinae oleum
Theridion
Thuja occidentalis
Topaz
Uric acid
Zinc hypophosphite
Zinc isovalerate
PART 3
(Article 5(1)(c)(i) and (2)(c)(i))
Unit preparations diluted to at least one part in ten (1x)
Abies excelsa
Abies nigra
Abies nobilis
Acalypha indica
Agate
Alisma plantago aq.
Alstonia scholaris
Aluminium
Amber (Succinum)
Ambra grisea
Ammonium phosphate
Angostura
vera
Anthoxanthum
Apis
mellifera
Aqua
marina
Aqua mellis
Aralia racemosa
Aranea diadema
Arum maculatum
Arum triphyllum
Asarum
Asperula odorata
Astacus fluviatilis
Auric chloride
Badiaga
Beech (Fagus sylvestris)
Bellis perennis
Berberis aquifolium
Borago officinalis
Butyric acid
Calcium chloride
Calcium metal
Calcium oxide
Calcium sulphate
Castoreum
Ceanothus americanus
Cedron
Cerato (Ceratostigma willmottiana)
Cherry plum (Prunus cerasifera)
Chestnut, red and sweet
Cholesterinum
Chrysolite
Cistus Canadensis
Clematis erecta
Conchae vera
Conchiolinum
Corallium rubrum
Crab apple
Crocus sativus
Erbium
Erigeron canadense
Fuligo
Genista tinctoria
Geum urbanum
Glycogen
Gnaphalium leontopodium
Gold
Gorse (Ulex europocus)
Graphites
Gratiola officinalis
Gymnocladus (American coffee tree)
Haematoxylon campechianum
Hecla lava (ash from Mount Hecla)
Hedeoma pulegioides
Hedera helix
Heliotrope
Heracleum spondylium
Herniaria
Hornbeam (Carpinus betulus)
Iberis amara
Impatiens
Iris
germanica
Iris
pseudacorus
Jacaranda
procera
Jatropha
curcas
Juncus
communis
Justicia adhatoda
Lamium album
Laurocerasus
Laurus nobilis oil
Ledum palustre
Lilium tigrinum
Lonicera caprifolium
Lysimachia
vulgaris
Magnesite
Magnesium
phosphate
Magnolia
Marum verum
Melilotus officinalis
Menispermum canadense
Mephitis putorius
Mercurialis perennis
Mimulus (Mimullis guttatus)
Moschus
Myrica gale
Myrtus communis
Ocimum basilicum
Olive
Oxalis acetosella
Pangamic acid
Paullinia cupana
Penthorum sedoides
Pollen (mixed)
Polygonatum multiflorum
Polygonum
aviculare
Polypodium
vulgare
Primula
vulgaris
Prunella
vulgaris
Ptelea trifoliata
Ratanhia
Robinia pseudoacacia
Rubia tinctorum
Rumex acetosella
Sal marina
Sarcolactic acid
Sarracenia purpurea
Scleranthus (Scleranthus annuus)
Silica
Silphium laciniatum
Sodium benzoate
Spongia marina
Star of Bethlehem (Ornithogalum
umbellatum)
Ulmus campestris
Vine
Walnut (juglerus regia)
Water violet (Hottonia palustris)
Wild oat
Wild rose
PART 4
(Article 5(1)(c)(ii) and (2)(c)(ii))
Unit preparations diluted to at least one part in ten (1x) for
external use
Adonis vernalis
Agaricus bulbosus
Agaricus muscarius
Agnus castus
Ailanthus glandulosa
Alum
Amethyst
Ammonium iodide
Amygdalae amarae
Apatite
Apocynum androsaemifolium
Apocynum cannabinum
Argentite
Argentum chloride
Argentum iodide
Artemisia cina
Aspidium anthelmintica
Aspidium filix-mas
Aurum Sulphide
Balsamum copaivae
Balsamum peruvianum
Barium citrate
Barium sulphate
Bismuth metal
Bismuth subgallate
Bismuth subnitrate
Boletus laricis
Bovista
Cade oil
Calcium fluoride
Carduus marianus
Cedar wood oil
Cerium oxalicum
Chalcocite
Chalcopyrite
Chelidonium majus
Chenopodium
oil
Colocynthis
Convallaria
majalis
Copper
silicate, nat
Crotalus
horridus
Cucumis
melo
Cucurbita
Datura
stramonium
Derris
Diamond
Ephedra vulgaris
Ferric acetate
Ferrous iodide
Ferrous oxalate
Ferrous sulphide
Formic acid
Gall
Gelsemium sempervirens
Gneiss
Hamamelis virginiana
Hepar sulfuris
Hyoscyamus
niger
Iris
Florentine
Jaborandi
Juniperus
Sabina
Kaolinite
Lachmanthus
tinctoria
Lapis
albus
Lycopodium
Magnesium
Magnesium
acetate
Magnesium
chloride
Magnesium
chloride
Magnetite
Magnetite
Manganese
acetate
Manganese
acetate
Nicotiana tabacum
Nicotiana tabacum oil
Oleander
Opuntia
vulgaris
Oxalic
acid
Petroleum
Phellandrium
aquaticum
Pix
liquida
Platinum
Platinum
chloride
Potassium
hydroxide
Potassium
silicate
Pyrethrum
Pyrolusite
Ranunculus
acris
Ranunculus
bulbosus
Ranunculus
flammula
Ranunculus
repens
Ranunculus
sceleratus
Rhodium
oxynitrate
Rhododendron chrysanthemum
Rhus toxicodendron
Salicylic acid
Scrophularia aquatica
Sodium aluminium chloride
Sodium auro-chloride
Sodium hypochlorite
Sodium nitrate
Squill
Stannum metal
Sulphur iodide
Tannic acid
Terebinthinae oleum
Topaz
Uric acid
Zinc hypophosphite
Zinc isovalerate