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No. S 549

Medicines Act

(CHAPTER 176)

Medicines (Product Licence) (Exemption)
(Amendment) Order 2016

In exercise of the powers conferred by section 9 of the Medicines Act, the Minister for Health makes the following Order:

Citation and commencement

1. This Order is the Medicines (Product Licence) (Exemption) (Amendment) Order 2016 and comes into operation on 1 November 2016.

Amendment of paragraph 2

2. Paragraph 2 of the Medicines (Product Licence) (Exemption) Order (O 18) is amended by inserting, immediately after the words “ “healthcare establishment” ”, the words “, “medical clinic” ”.

Deletion and substitution of paragraph 3

3. Paragraph 3 of the Medicines (Product Licence) (Exemption) Order is deleted and the following paragraph substituted therefor:

“Product licence not necessary in certain circumstances

3. Sections 5(1) and 6(4) of the Act do not apply to any person who sells, supplies, assembles or manufactures a medicinal product that is assembled or manufactured —

(a)	under an agreement with the holder of a licence issued under the Private Hospitals and Medical Clinics Act (Cap. 248) for a private hospital, medical clinic or healthcare establishment;
(b)	in accordance with the written instructions of a doctor or dentist practising at that private hospital, medical clinic or healthcare establishment;
(c)	for the use solely by, or in connection with, a patient at that private hospital, medical clinic or healthcare establishment; and
(d)	in premises approved by the Authority.”.

Made on 25 October 2016.

CHAN HENG KEE

Permanent Secretary,
Ministry of Health,
Singapore.

[HSA/LPPD/711:12/72-005; AG/LEGIS/SL/176/2015/11 Vol. 1]