Singapore legislation
Section 33
Section 33
Compliance with standards specified in monographs in certain publications
(1)
A person must not —
sell a medicinal product which has been demanded by the purchaser by or by express reference to a particular name; or
sell or supply a medicinal product pursuant to 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)
A person must not 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 must be taken not to comply with the standard specified in the relevant monograph if, insofar 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 —
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;
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;
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 —
the monograph headed by that name in the current edition of the British Pharmacopoeia, the European Pharmacopoeia or the United States Pharmacopoeia; or
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 —
if it is the current edition of that publication, must 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 mentioned in subsection (4)); or
if it is an edition previous to the current edition of that publication, must 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 is to 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 is to be construed accordingly.
(7)
The Minister may by order amend subsections (4), (5) and (6).