37.—(1) Where, in the circumstances described in regulation 36(1), the Minister proposes to cancel an approval or, as the case may be, registration, relating to the exercise of an establishment activity on an approved or, as the case may be, registered, third country establishment, he shall not cancel it unless—
(a)he serves a written notice complying with the requirements of paragraph (2) on the representative established within the United Kingdom of the establishment (“the recipient”), and
(b)after the time for compliance with the notice has expired, he is not satisfied that the manufacturer or, as the case may be, the recipient, has complied with the requirements specified in the notice.
(2) A notice served by the Minister under paragraph (1) shall—
(a)state that he proposes to cancel the approval or, as the case may be, registration, relating to the establishment activity concerned, because he is not satisfied that—
(i)the manufacturer is complying, in relation to that activity, with the essential conditions, or, as the case may be,
(ii)the recipient is complying with the essential representative conditions;
(b)specify—
(i)the essential conditions or, as the case may be, the essential representative conditions, he is not satisfied that the manufacturer or, as the case may be, the recipient, is complying with; and
(ii)the requirements that the manufacturer or, as the case may be, the recipient, must comply with in order to satisfy the Minister as to compliance with those essential conditions or, as the case may be, those essential representative conditions; and
(c)state that, unless he is satisfied that the manufacturer or, as the case may be, the recipient, has complied with those requirements, within such reasonable time as is specified in the notice, the approval or, as the case may be, registration, relating to the establishment activity concerned will be cancelled.