On 20/05/2013,
you requested for the version in force on 20/05/2013
incorporating all amendments published on or before 20/05/2013.
The closest version currently available is that of 01/09/2008.
PART III
FURTHER PROVISIONS RELATING TO DEALINGS WITH MEDICINAL PRODUCTS
23.1
—(1) The Minister may by order specify descriptions or classes of medicinal products, as being products which in his opinion can with reasonable safety be sold or supplied otherwise than by or under the supervision of a pharmacist.
(2) In this Act any reference to a medicinal product on a general sale list is a reference to a medicinal product of a description, or falling within a class, specified in an order under this section which is for the time being in force.
1 wef 3.5.93 vide S156/93
24. 2Subject to any exemption conferred by or under this Part, on and after such day as the Minister may appoint for the commencement of this Part (referred to in this Part as the appointed day) no person shall sell by retail or supply in circumstances corresponding to retail sale any medicinal product which is not a medicinal product on a general sale list, unless —
(a)
the product is sold or supplied on premises which are a registered pharmacy; and
(b)
that person is or acts under the personal supervision of a pharmacist.
2 wef 3.5.93 vide S156/93
25. 3Nothing in this Act shall prevent any person from selling by retail or supplying in circumstances corresponding to retail sale any medicinal product on a general sale list subject to such conditions as may be prescribed for the purposes of this section.
3 wef 3.5.93 vide S156/93
26. 4On and after the appointed day a medicinal product shall not be sold by means of an automatic machine unless it is a medicinal product in the automatic machine section of a general sale list and complies with such conditions as may be prescribed.
4 wef 3.5.93 vide S156/93
27.5
—(1) The restrictions imposed by section 24 shall not apply to the supply of a medicinal product —
(a)
by a doctor or dentist to his patient; or
(b)
by a hospital where the product is supplied for the purpose of being administered in accordance with the directions of a doctor or a dentist.
(2) The restrictions imposed by that section shall not apply to the supply of a medicinal product by a veterinary surgeon for administration by him or under his direction to an animal under his care.
(3) The restrictions imposed by that section shall not apply to anything done at premises of which the person carrying on the business in question is the occupier and which he is able to close so as to exclude the public, and which consists of the sale or the supply in circumstances corresponding to retail sale of a herbal remedy where the processes to which the plant or plants are subjected consist of drying, crushing or comminuting, with or without diluting with water, but not any other process.
5 wef 3.5.93 vide S156/93
28.6
—(1) The Minister may by order provide that section 24 shall have effect subject to such exemptions (other than those for the time being having effect by virtue of section 27) as may be specified in the order.
(2) Any exemption conferred by an order under subsection (1) may be conferred subject to such conditions or limitations as may be specified in the order.
(3) The Minister may by order provide that section 27 shall have effect subject to such exceptions or modifications as may be specified in the order.
6 wef 3.5.93 vide S156/93
29.7
—(1) The Minister may by order specify descriptions or classes of medicinal products for the purposes of this section; and, in relation to any description or class so specified, the order shall state which of the following are to be appropriate practitioners for the purposes of this section:
(a)
doctors;
(b)
dentists; and
(c)
veterinary surgeons.
(2) Subject to the following provisions of this section —
(a)
no person shall sell by retail, or supply in circumstances corresponding to retail sale, a medicinal product of a description, or falling within a class, specified in an order under this section except in accordance with a prescription given by an appropriate practitioner; and
(b)
no person shall administer (otherwise than to himself) any such medicinal product unless he is an appropriate practitioner or a person acting in accordance with the directions of an appropriate practitioner.
(3) An order made by the Minister for the purposes of this section may provide —
(a)
that subsection (2)(a) or (b), or subsection (2)(a) and (b), shall have effect subject to such exemptions as may be specified in the order; or
(b)
that, for the purpose of subsection (2)(a), a medicinal product shall not be taken to be supplied in accordance with a prescription given by an appropriate practitioner unless such conditions as are prescribed by the order are fulfilled.
(4) Any exemption conferred by an order in accordance with subsection (3)(a) may be conferred subject to such conditions or limitations as may be specified in the order.
7 wef 3.5.93 vide S156/93
Prohibition of sale, supply or importation of medicinal products of specified description or of animal feeding stuffs incorporating such products
30.
—(1) The Minister may, where it appears to him to be necessary to do so in the interests of safety, by order —
(a)
prohibit the sale or supply, or the importation, of medicinal products of any description, or falling within any class, specified in the order; and
(b)
prohibit the sale or supply, or the importation, of animal feeding stuffs in which medicinal products of any description, or falling within any class, specified in the order have been incorporated.
(2) A prohibition imposed by order under this section may be a total prohibition or may be imposed subject to such exceptions as may be specified in the order.
31. No person shall —
(a)
add any substance to, or abstract any substance from, a medicinal product so as to affect injuriously the composition of the product, with intent that the product shall be sold or supplied in that state; or
(b)
sell or supply any medicinal product whose composition has been injuriously affected by the addition or abstraction of any substance.
32.8
—(1) No person shall, to the prejudice of the purchaser, sell any medicinal product which is not of the nature or quality demanded by the purchaser.
(2) For the purposes of this section the sale of a medicinal product shall not be taken to be otherwise than to the prejudice of the purchaser by reason only that the purchaser buys the product for the purpose of analysis or examination.
(3) Subsection (1) shall not be taken to be contravened by reason only that a medicinal product contains some extraneous matter, if it is proved that the presence of that matter was an inevitable consequence of the process of manufacture of the product.
(4) Subsection (1) shall not be taken to be contravened by reason only that a substance has been added to, or abstracted from, the medicinal product, if it is proved that —
(a)
the addition or abstraction was not carried out fraudulently, and did not injuriously affect the composition of the product; and
(b)
the product was sold having attached to it, or to a container or package in which it was sold, a conspicuous notice of adequate size and legibly printed, specifying the substance added or abstracted.
(5) Where a medicinal product is sold or supplied in pursuance of a prescription given by a practitioner, subsections (1) to (4) shall have effect as if —
(a)
in those provisions any reference to sale included a reference to supply and (except as provided by paragraph (b)) any reference to the purchaser included a reference to the person for whom the product was prescribed by the practitioner; and
(b)
in subsection (1), for the words “demanded by the purchaser”, there were substituted the words “specified in the prescription”.
8 wef 3.5.93 vide S156/93
33.9
—(1) No person shall —
(a)
sell a medicinal product which has been demanded by the purchaser by or by express reference to a particular name; or
(b)
sell or supply a medicinal product in pursuance of a prescription given by a practitioner in which the product required is described by or by express reference to a particular name,
if that name is a name at the head of the relevant monograph and the product does not comply with the standard specified in that monograph.
(2) No person shall sell or supply a medicinal product by or by express reference to a particular name, if that name is a name at the head of the relevant monograph unless the product complies with the standard specified in that monograph.
(3) Where a medicinal product is sold or supplied in the circumstances specified in subsection (1) or (2), and the name in question is the name, not of the product itself, but of an active ingredient of the product, then for the purposes of the subsection in question the product shall be taken not to comply with the standard specified in the relevant monograph if, in so far as it consists of that ingredient, it does not comply with the standard so specified.
(4) In this section “publication” means one of the following, that is to say, the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopoeia, the British Pharmaceutical Codex and the British Veterinary Codex; and “the relevant monograph”, in relation to the sale or supply of a medicinal product by or by express reference to a particular name —
(a)
if, together with that name, there was specified a particular edition of a particular publication, means the monograph headed by that name in that edition of that publication or if there is no such monograph in that edition, means the appropriate current monograph headed by that name;
(b)
if, together with that name, there was specified a particular publication, but not a particular edition of that publication, means the monograph headed by that name in the current edition of that publication, or, if there is no such monograph in that edition, means the appropriate current monograph headed by that name, or, in default of such a monograph, means the monograph headed by that name in the latest edition of the specified publication which contained a monograph so headed;
(c)
if no publication was specified together with that name, means the appropriate current monograph,
and “current” means current at the time when the medicinal product in question is sold or supplied.
(5) In this section
“the appropriate current monograph”, in relation to a particular name, means —
(a)
the monograph headed by that name in the current edition of the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopoeia; or
(b)
if there is no such monograph, then the monograph headed by that name in the current edition of the British Pharmaceutical Codex or the British Veterinary Codex .
(6) For the purposes of this section an edition of a publication —
(a)
if it is the current edition of that publication, shall be taken as it is for the time being in force (that is to say, together with any amendments, additions and deletions made to it up to the time referred to in subsection (4)); or
(b)
if it is an edition previous to the current edition of that publication, shall be taken as it was immediately before the time when it was superseded by a subsequent edition of that publication (that is to say, together with any amendments, additions and deletions made to it up to that time),
and any monograph in an edition of a publication shall be construed in accordance with any general monograph or notice or any appendix, note or other explanatory material which is contained in that edition and is applicable to that monograph, and any reference in this section to compliance with the standard specified in a monograph shall be construed accordingly.
9 wef 3.5.93 vide S156/93
34.
—(1) The Minister may by regulations prescribe such requirements as he may consider necessary or expedient with respect to any of the following matters:
(a)
the manner in which, or persons under whose supervision, medicinal products may be prepared or may be dispensed;
(b)
the amount of space to be provided in any premises for persons preparing or dispensing medicinal products, the separation of any such space from the remainder of the premises, and the facilities to be provided in any premises for such persons;
(c)
the amount of space to be provided in any premises for the sale or supply of medicinal products;
(d)
the accommodation (including the amount of space) to be provided in any premises for members of the public to whom medicinal products are sold or supplied or for whom medicinal products are being prepared or assembled;
(e)
the amount of space to be provided in any premises for the storage of medicinal products;
(f)
the safekeeping of medicinal products;
(g)
the disposal of medicinal products which have become unusable or otherwise unwanted;
(h)
precautions to be observed before medicinal products are sold or supplied;
(i)
the keeping of records relating to the sale or supply of medicinal products;
(j)
the supply of medicinal products distributed as samples;
(k)
sanitation, cleanliness, temperature, humidity or other factors relating to the risks of deterioration or contamination in connection with the manufacture, storage, transportation, sale or supply of medicinal products;
(l)
the construction, location and use of automatic machines for the sale of medicinal products.
(2) Without prejudice to the generality of subsection (1), such regulations may prescribe requirements in respect of —
(a)
the construction, lay-out, drainage, equipment, maintenance, ventilation, lighting and water supply of premises at or from which medicinal products are manufactured, stored, transported, sold or supplied;
(b)
the disposal of refuse at or from any such premises; and
(c)
any apparatus, equipment, furnishings or utensils used at any such premises.
35.
—(1) Any person who contravenes section 24, 26, 29, 31, 32 or 33 or who contravenes any order made under section 30, shall be guilty of an offence.
(2) Where a medicinal product is sold, supplied or imported in contravention of an order made under section 30, any person who, otherwise than for the purpose of performing or exercising a duty or power imposed or conferred by or under this Act or any other written law, is in possession of the medicinal product, knowing or having reasonable cause to suspect that it was sold, supplied or imported in contravention of the order, shall be guilty of an offence.
(3) Any person guilty of an offence under subsection (1) or (2) shall be liable on conviction to a fine not exceeding $5,000 or to imprisonment for a term not exceeding 2 years or to both.
(4) Any person who contravenes any conditions prescribed for the purpose of section 25 shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $2,000.