No. S 309
Medicines Act
(Chapter 176)
Medicines (Licensing, Standard Provisions
and Fees) (Amendment) Regulations 2001
In exercise of the powers conferred by sections 15 and 74 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 (Licensing, Standard Provisions and Fees) (Amendment) Regulations 2001 and shall come into operation on 1st September 2001.
Amendment of regulation 3
2.  Regulation 3 of the Medicines (Licensing, Standard Provisions and Fees) Regulations (Rg 6) is amended —
(a)by inserting, immediately after the word “except” in paragraph (4)(a), the words “for paragraph 4(b) thereof and except”; and
(b)by deleting the words “paragraph 4” in paragraph (4)(a)(i) and substituting the words “paragraph 4(a)”.
Amendment of Fourth Schedule
3.  The Fourth Schedule to the Medicines (Licensing, Standard Provisions and Fees) Regulations is amended —
(a)by deleting paragraph 4 and substituting the following paragraph:
4.  The holder of the licence shall —
(a)conduct all manufacture and assembly operations in such a way as to ensure that the medicinal products are of the correct identities and conform with the standards of strength, quality and purity applicable to them under the relevant product licences; and
(b)comply with the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-operation Scheme Guide to Good Manufacturing Practice for Medicinal Products, as revised or amended from time to time.”; and
(b)by inserting, immediately after paragraph 5, the following paragraph:
5A.  Where the holder of the licence does not carry out the tests referred to in paragraph 5 himself, he shall engage a testing laboratory that is approved by the licensing authority to carry out the tests.”.

Made this 1st day of June 2001.

MOSES LEE
Permanent Secretary,
Ministry of Health,
Singapore.
[NPA(GMP) 78:01/2(cf); AG/LEG/SL/176/97/4 Vol.1]