Singapore legislation
Regulation 5
of Health Products (Clinical Research Materials) Regulations 2016
Regulation 5
Approval for import of consignments of clinical research materials containing psychotropic substances
Subregulation 1
Despite regulation 3(2), an importer must not import any clinical research material that is a therapeutic product and that contains any psychotropic substance, except under and in accordance with a prior approval of the Authority for each consignment of the material to be imported.
Subregulation 2
An application for an approval under paragraph (1) must —
be made in the form and manner specified on the Authority’s website;
be accompanied by such particulars, information, documents and samples as the Authority may require; and
be accompanied by the relevant fee.
Subregulation 3
Upon receiving an application under this regulation, the Authority may approve the application or refuse to approve the application.
Subregulation 4
The Authority may subject its approval to such conditions as the Authority thinks necessary and may, from time to time, by notice in writing to the person granted the approval —
modify or remove any condition of the approval; or
impose any new condition on the approval.
Subregulation 5
The conditions referred to in paragraph (4) may include a condition limiting the quantity which may be imported in the consignment under the approval, and different limits may be imposed under different approvals.
Subregulation 6
The Authority may, at any time, suspend or revoke any approval.
Subregulation 7
To avoid doubt, this regulation applies in addition to regulation 4.
Subregulation 8
In this regulation, “prior approval of the Authority” includes a permission given before 1 November 2016 by the licensing authority under the Medicines Act 1975, for the importer to import a consignment of the clinical research material on or after that date in accordance with the conditions of the permission (if any).