Regulation 61
Certification of therapeutic products intended for export
of Health Products (Therapeutic Products) Regulations 2016
Subregulation 1
The Authority may, on the application of a person who intends to export a therapeutic product, issue to the person a certificate certifying —
in a case where the therapeutic product is registered under the Act, that it is so registered; or
in a case where the therapeutic product is not so registered, that it complies with such standards or requirements as may be specified in the certificate.
Subregulation 2
An application for a certificate under paragraph (1) must —
be made in the form and manner specified on the Authority’s website; and
be accompanied by the relevant fee.