No. S 525
Medicines Act
(Chapter 176)
Medicines (Labelling) (Amendment)
Regulations 1997
In exercise of the powers conferred by section 44 of the Medicines Act, the Minister for Health hereby makes the following Regulations:
Citation and commencement
1.  These Regulations may be cited as the Medicines (Labelling) (Amendment) Regulations 1997 and shall come into operation on 1st January 1999.
Deletion and substitution of regulation 5
2.  Regulation 5 of the Medicines (Labelling) Regulations (Rg 5) (referred to in these Regulations as the principal Regulations) is deleted and the following regulation substituted therefor:
Certain substances to be labelled
5.—(1)  This regulation applies where any medicinal product for human consumption or use, containing any substance specified in the first column of the First Schedule, not being a dispensed medicinal product, is sold by retail or supplied in circumstances corresponding to retail sale or is in the possession of any person for the purpose of such sale or supply.
(2)  Every container of a product referred to in paragraph (1) and, where the container is immediately enclosed in a package, the package shall be labelled with a statement in English declaring the presence of that substance which may describe that substance by a corresponding term specified in the second column of the First Schedule or any other equivalent term.”.
Amendment of regulation 6
3.  Regulation 6 of the principal Regulations is amended by inserting, immediately before the word “Schedule” in the second line, the word “Second”.
Amendment of regulation 7
4.  Regulation 7 of the principal Regulations is amended by inserting, immediately before the word “Schedule” in the second line of paragraph (b), the word “Second”.
New First Schedule
5.  The principal Regulations are amended by inserting, immediately after regulation 9, the following Schedule:
Regulation 5
Term to be used
tartrazine (Code E102)
tartrazine (Code 102)
tartrazine (Code FD and C Yellow No. 5)
2.Benzoic acid
benzoic acid
benzoic acid (Code E210)
3.Sodium benzoate
sodium benzoate
sodium benzoate (Code E211)
Amendment of existing Schedule
6.  The principal Regulations are amended by deleting the words “THE SCHEDULE” and substituting the words “SECOND SCHEDULE”.
Made this 19th day of November 1997.
Permanent Secretary,
Ministry of Health,
[PD (DAD) 36:36/23 Vol. 2; AG/LEG/SL/176/95/2 Vol. 3]