
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.