5. Approval for import of consignments of clinical research materials containing psychotropic substances

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.

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.

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

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.

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.

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

To avoid doubt, this regulation applies in addition to regulation 4.

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).

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.

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.

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

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.

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.

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

To avoid doubt, this regulation applies in addition to regulation 4.

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).