In forceAmendedAs enacted

Contents

Health Products (Clinical Research Materials) Regulations 2016 · As enacted · Part 2 · Exceptions for Manufacture, Import and Supply of Clinical Research Materials

6. Approval for export of consignments of certain clinical research materials

Feedback & support

Amended

Last amended by an amending law of 2022. 2 amendments in all.

(1)

This regulation applies to any clinical research material that is a therapeutic product and that —

(a)

contains any psychotropic substance; or

(b)

is a codeine cough preparation.

(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.

(3)

An application for an approval under paragraph (2) must —

(a)

be made in the form and manner specified on the Authority’s website;

(b)

be accompanied by such particulars, information, documents and samples as the Authority may require; and

(c)

be accompanied by the relevant fee, if the material contains any psychotropic substance.

(4)

Upon receiving an application under this regulation, the Authority may approve the application or refuse to approve the application.

(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 —

(a)

modify or remove any condition of the approval; or

(b)

impose any new condition on the approval.

(6)

The Authority may, at any time, suspend or revoke any approval.

(7)

In this regulation, “codeine cough preparation” means a therapeutic product that —

(a)

is in liquid or solid form;

(b)

contains codeine or its salts; and

(c)

is intended for the treatment of coughs.

Subregulation 1