Medicines (Sale and
Supply) (Miscellaneous Provisions) (Jersey) Order 1997[1]
THE HEALTH AND SOCIAL SERVICES COMMITTEE in pursuance of Articles 52, 60, 65, 66, 84 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;
“effervescent”,
in relation to a tablet, means containing not less than 75%, by weight of the
tablet, of ingredients included wholly or mainly for the purpose of releasing
carbon dioxide when the tablet is dissolved or dispersed in water;
“health prescription”
means a prescription described in Article 15(2) of the Health
Insurance (Jersey) Law 1967;
“Law” means
the Medicines
(Jersey) Law 1995;
“pharmacy medicine”
means a medicinal product that is not a prescription only medicine, and
either –
(a) is
not a medicinal product on a general sale list; or
(b) is a
product to which Article 5 of this Order refers and is not presented for
sale in the manner described in relation to that product in that Article;
“prescription only
medicine” has the same meaning as it has in Article 1(1) of the Medicines
(Prescription Only) (Jersey) Order 1997;
“register”
means –
(a) a
book whose leaves are bound in; or
(b) a
computerized record;
“registered optometrist”
has the same meaning as it has in Article 1(1) of the Opticians
(Registration) (Jersey) Law 1962;
“repeatable prescription”
means a prescription containing a direction that it shall or may be dispensed
more than once.[2]
(2) In
this Order –
(a) a
reference to selling anything by way of wholesale dealing includes, except in Article 3(1),
selling by way of wholesale dealing by the person who manufactured it; and
(b) a
reference to supplying anything by way of wholesale dealing means supplying it
to a person who receives it for one or more of the purposes specified in Article 3(2)
of the Law.
(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 Safekeeping
of medicinal products[3]
(1) Every
person conducting a retail pharmacy business shall install and maintain at
every premises where the business is conducted an intruder alarm system in
accordance with paragraph (2).
(2) The
alarm system mentioned in paragraph (1) shall be activated whenever the
premises are unoccupied and shall be capable of detecting entry by any intruder
and alerting a monitoring station operated by a person approved by the
Minister.
3 Special restrictions on persons who may be supplied with
prescription only or pharmacy medicines
(1) No
person –
(a) being
the holder of a product licence; or
(b) in
the course of a business carried on by the person and consisting (wholly or
partly) of manufacturing medicinal products or of selling medicinal products by
way of wholesale dealing,
shall sell a prescription
only medicine or a pharmacy medicine by way of wholesale dealing to any person
who does not fall within a class specified in Schedule 1.
(2) The
restrictions in paragraph (1) shall not apply to a sale by way of
wholesale dealing, to a person specified in column 1 of any Part of Schedule 2
to the Medicines
(Prescription Only) (Jersey) Order 1997, of a prescription only
medicine that is specified in the corresponding paragraph in column 2 of that Part
in relation to that person.
(3) The
restrictions in paragraph (1) shall not apply to a sale to a person by way
of wholesale dealing of a prescription only medicine that the person may sell
by retail, or supply in circumstances corresponding to retail sale, free from
the restrictions in Article 57(2) of the Law, by reason of Article 7
of the Medicines
(Prescription Only) (Jersey) Order 1997.
(4) The
restrictions in paragraph (1) shall not apply to a sale by way of
wholesale dealing, to a registered optometrist, of –
(a) an
eye ointment that contains Oxyphenbutazone; or
(b) one
or more medicinal products that are prescription only medicines by reason only
that they contain any of the following substances –
Amethocaine hydrochloride
Framycetin sulphate
Lignocaine hydrochloride
Oxybuprocaine hydrochloride
Proxymetacaine hydrochloride and
Thymoxamine hydrochloride.[4]
(5) The
restrictions in paragraph (1) shall not apply to a sale, by way of
wholesale dealing, of a pharmacy medicine to a person who requires it for the
purpose of administering it lawfully to a human being in the course of a
business carried on by the purchaser.
(6) The
restrictions in paragraph (1) shall not apply to a sale of a pharmacy
medicine, by way of wholesale dealing, to a person who –
(a) under
an Order made under Article 54(2)(b) of the Law;
(b) under
Article 55 of the Law; or
(c) under
an Order made under Article 56(1) of the Law,
may sell such a pharmacy
medicine by retail, or supply it in circumstances corresponding to retail sale,
otherwise than by or under the supervision of a pharmacist.
4 Pharmacy records
(1) Every
person conducting a retail pharmacy business shall –
(a) keep
a register of prescription only medicines that are sold and supplied in the
course of the business; and
(b) enter
in the register, in respect of every sale or supply of a prescription only
medicine and at the time specified in paragraph (2) of this Article, the
relevant information in paragraph 1, 2, 3 or 4 of Schedule 2 to this Order.
(2) The
information shall be entered in the register –
(a) if it
is reasonably practicable to do so, on the day on which the prescription only
medicine is sold or supplied; or
(b) if
not, on the following day,
except that where the
medicine is sold or supplied in accordance with Article 9(1) of the Medicines
(Prescription Only) (Jersey) Order 1997 (by reason that the
conditions in paragraph (2) of that Article are fulfilled), the
information in paragraph (1)(e) and (f) of Schedule 2 to this Order
may be entered on the day on which the prescription relating to the sale or
supply is received.
(3) The
requirements of paragraph (1) shall not apply in any of the following
cases –
(a) a
sale or supply in pursuance of a health prescription or a prescription for oral
contraceptives;
(b) a
sale or supply, where a separate record of the transaction is made under Article 16
of the Misuse of Drugs (General Provisions) (Jersey) Order 1989;
(c) a
sale by way of wholesale dealing, where the order or invoice relating to the
sale (or a copy) is retained by the person conducting the retail pharmacy
business; or
(d) a
sale or supply to a person employed or engaged, lawfully, in connection with a
scheme for testing the quality of drugs supplied under the Health
Insurance (Jersey) Law 1967.
(4) Every
person conducting a retail pharmacy business shall preserve for a period of 2
years from the relevant date –
(a) the
register that is to be kept under paragraph (1) of this Article;
(b) every
prescription (other than a health prescription) under which any prescription
only medicine has been sold or supplied;
(c) every
order or invoice (or copy) to which paragraph (3)(c) of this Article
refers; and
(d) every
order to which column 3 of any Part of Schedule 2 to the Medicines
(Prescription Only) (Jersey) Order 1997
refers, except an order to which paragraph 3 of Part 1 of that Schedule
refers.
(5) In
paragraph (4) the “relevant date” means –
(a) in
relation to sub-paragraph (a) of that paragraph, the date on which the
last entry was made in the register; and
(b) in
relation to sub-paragraphs (b), (c) and (d) of that paragraph –
(i) where the
prescription only medicine was sold or supplied under a repeatable
prescription, the date of the final sale or supply pursuant to that
prescription, and
(ii) in
every other case, the date on which the prescription only medicine was sold or
supplied.
(6) Any
person who contravenes any provision of this Article shall be guilty of an
offence and liable to a fine not exceeding level 3 on the standard scale.
5 Additional conditions for
sale or supply elsewhere than at pharmacy [5]
(1) Where
a medicinal product is in the course of a business sold by retail, offered or
exposed for sale by retail, or supplied in circumstances corresponding to
retail sale, elsewhere than at a pharmacy, the conditions in the following paragraphs
of this Article are prescribed conditions for the purpose of Article 52 of
the Law.
(2) Where
the medicinal product is for human use and contains aloxiprin, aspirin or
paracetamol, the product shall be presented for sale in a separate and
individual container, or package, containing –
(a) in
the case of effervescent tablets that do not include aspirin or in which the
amount of aspirin does not exceed 325 mg per tablet, not more than 30 tablets;
(b) in
the case of effervescent tablets that include aspirin, where the amount of
aspirin exceeds 325 mg per tablet but does not exceed 500 mg per tablet, not
more than 20 tablets;
(c) in
the case of tablets that are not effervescent, where they are enteric-coated
and contain aspirin only and the amount of aspirin in each tablet does not
exceed 75 mg, not more than 28 tablets;
(d) in
the case of tablets that are not effervescent, where they are not tablets to
which sub-paragraph (c) applies, not more than 16 tablets;
(e) in
the case of powder or granules, not more than 10 sachets;
(f) in
the case of capsules, not more than 16 capsules;
(g) in
the case of liquid preparations of paracetamol that are intended for persons
aged not less than 12 years, not more than 160 millilitres of the product; and
(h) in
the case of liquid preparations of paracetamol that are intended for persons
aged less than 12 years, individual unit doses (to a maximum of 20 unit doses)
not exceeding 5 ml each.
(3) Where
the medicinal product is for human use and contains sodium picosulphate –
(a) in
the case of gel-filled capsules, the product shall be presented in a separate
and individual container, or package, containing not more than 24 capsules; and
(b) in
any other case, the product shall be presented for sale in a separate and
individual container, or package, containing not more than 60 ml of the
product.
(4) Where
the medicinal product is for human use and contains loperamide hydrochloride,
the product shall be presented for sale in a separate and individual container,
or package, containing not more than 6 tablets or capsules.
(5) Where
the medicinal product is for human use and contains mepyramine maleate, the
product shall be presented for sale in a separate and individual container or
package containing not more than 20 g of the product.
(6) Where
the medicinal product is for human use and contains bisacodyl, the product
shall be presented for sale in a separate and individual container or package
containing not more than 20 tablets.
(7) Where
the medicinal product is for human use and contains heparinoid, the product
shall be presented for sale in a separate and individual container or package
containing not more than 20 g of the product.
6 Citation
This Order may be cited
as the Medicines (Sale and Supply) (Miscellaneous Provisions) (Jersey)
Order 1997.
SCHEDULE 1
(Article 3(1))
Classes of persons to whom
restrictions on supply of prescription only and pharmacy medicines do not apply
1 Practitioners.
2 Persons
who are, within the meaning of Article 68(3) of the Law, lawfully
conducting retail pharmacy businesses.
3 Authorities
or persons carrying on the business of a hospital or health centre.
4 Holders
of wholesale dealer’s licences.
5 Persons
to whom, by reason of any exemption conferred by or under the Law or by reason
of Article 47 of the Law, the restrictions in Article 9(3) of the Law
do not apply.
6 States
departments, and officers of those departments in the course of their duties.
SCHEDULE 2
(Article 4(1)(b))
Information to be entered in
pharmacy registers
1 Where
the sale or supply of a prescription only medicine is made under a prescription
given by a practitioner or in accordance with Article 9(1) of the Medicines
(Prescription Only) (Jersey) Order 1997 (by reason that the
conditions in paragraph (2) of that Article are fulfilled), the
information to which Article 4(1)(b) of this Order refers is –
(a) the date on which the prescription only
medicine is sold or supplied;
(b) the
name, quantity and (unless it is apparent from the name) the pharmaceutical
form and strength of the prescription only medicine;
(c) the
name and address of the practitioner giving the prescription;
(d) the
name and address of the person for whom the prescription only medicine is
prescribed;
(e) the
date on the prescription; and
(f) in
relation to the sale or supply of a prescription only medicine in accordance
with Article 9(1) of the Medicines
(Prescription Only) (Jersey) Order 1997,
the date on which the prescription relating to that sale or supply is received.
2 Where
the sale or supply is made under a repeatable prescription, and is not the first
sale or supply under that prescription –
(a) the
date on which the prescription only medicine is sold or supplied; and
(b) a
reference to an entry made in the register, in accordance with paragraph 1 of
this Schedule, in respect of the first sale or supply under that prescription,
may be entered in the
register instead of the information in that paragraph.
3 Where
the sale or supply of a prescription only medicine is a sale or supply in
accordance with Article 9(1) of the Medicines
(Prescription Only) (Jersey) Order 1997 (by reason that the
conditions in paragraph (3) of that Article are fulfilled), the
information to which Article 4(1)(b) of this Order refers is –
(a) the
date on which the prescription only medicine is sold or supplied;
(b) the
name, quantity and (unless it is apparent from the name) the pharmaceutical
form and strength of the prescription only medicine;
(c) the
name and address of the person requesting the prescription only medicine; and
(d) the
nature of the emergency.
4 Where –
(a) the
sale or supply of a prescription only medicine is by way of wholesale dealing,
and no order or invoice (or copy of an order or invoice) relating to the
transaction has been retained under Article 4(3)(c) of this Order; or
(b) although
the sale or supply is by retail or in circumstances corresponding to retail
sale, it is one to which the restrictions in Article 57(2) of the Law do
not apply, because of an exemption conferred otherwise than by Article 9
of the Medicines
(Prescription Only) (Jersey) Order 1997,
the information to which Article 4(1)(b)
of this Order refers is –
(i) the date on which
the prescription only medicine is sold or supplied,
(ii) the
name, quantity and (unless it is apparent from the name) the pharmaceutical
form and strength of the prescription only medicine,
(iii) the
name and address, and the trade, business or profession of the person to whom
the prescription only medicine is sold or supplied, and
(iv) the
purpose for which the prescription only medicine is sold or supplied.