Section 35
Compliance with standards specified in monographs in certain publications
(1)
No person shall —
(a)
sell a medicinal product which has been requested by the purchaser 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.
Medicines
B.L.R.O. 5/2024 31
(4)
In this section “publication” means, the British Pharmacopeia, the
European
Pharmacopeia,
United
States
Pharmacopeia, the British Pharmaceutical Codex or the British Veterinary Codex; and
“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 the name, there was specified a particular edition of a particular publication, means the monograph headed by that name in that edition or if there is no such monograph in that edition, means the appropriate current monograph headed by that name;
(b)
if, together with the 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 “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;
(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; or
(c)
if there is no such monograph as in paragraphs (a)
and (b), then the monograph supplied by the manufacturer that has been approved during medicinal product registration.
Medicines 32
(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 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 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 in accordance with any general monograph or notice or any appendix, note or other explanatory material which is contained in that edition and which is applicable to that monograph, and any reference in this section to compliance with the standard specified in a monograph shall be constructed accordingly.
(7)
The Minister may, with the approval of His Majesty the Sultan and Yang Di-Pertuan and by order published in the Gazette amend subsections (4), (5) and (6).