Singapore legislation
Regulation 6
of Health Products (Clinical Research Materials) Regulations 2016
Regulation 6
Approval for export of consignments of certain clinical research materials
Subregulation 1
This regulation applies to any clinical research material that is a therapeutic product and that —
contains any psychotropic substance; or
is a codeine cough preparation.
Subregulation 2
Despite regulation 3(3), the person must not export the clinical research material except under and in accordance with a prior approval of the Authority for each consignment of the material to be exported.
Subregulation 3
An application for an approval under paragraph (2) 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, if the material contains any psychotropic substance.
Subregulation 4
Upon receiving an application under this regulation, the Authority may approve the application or refuse to approve the application.
Subregulation 5
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 6
The Authority may, at any time, suspend or revoke any approval.
Subregulation 7
In this regulation, “codeine cough preparation” means a therapeutic product that —
is in liquid or solid form;
contains codeine or its salts; and
is intended for the treatment of coughs.