Singapore legislation
Regulation 51
Regulation 51
Import of therapeutic products for patients’ use without importer’s licence
Subregulation 1
Subject to paragraph (3), a specified healthcare service licensee may, without holding an importer’s licence, import a therapeutic product that is not registered, if the therapeutic product —
is required by, and on the written instructions of, a qualified practitioner who is a personnel of the specified healthcare service licensee; and
is for the use of the qualified practitioner’s patient.
Subregulation 2
Subject to paragraph (3), the holder of a pharmacy licence may import, without holding an importer’s licence, a therapeutic product that is not registered, if the therapeutic product is intended for the use by a patient of a qualified practitioner pursuant to a valid prescription given by the qualified practitioner.
Subregulation 3
The Authority’s prior approval must be obtained for each consignment of a therapeutic product that is imported under paragraph (1) or (2), and the amount imported must not exceed —
a total dosage of 3 months per patient as recommended by the manufacturer of the therapeutic product; or
such other quantity as approved by the Authority.
Subregulation 4
An application for the Authority’s approval under paragraph (3) must be made in the form and manner specified on the Authority’s website.