Health Products (Therapeutic Products) Regulations 2016 · As enacted · Part 7 · Exceptions — Manufacture, Import and Wholesale of Therapeutic Products Without Licence
51. Import of therapeutic products for patients’ use without importer’s licence
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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.
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.
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.
An application for the Authority’s approval under paragraph (3) must be made in the form and manner specified on the Authority’s website.
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.