The Medicines (Advisory Bodies) Regulations 2005

Prospective

3.  For section 22 of the Act (procedure in other cases) substitute the following sections—U.K.

“Procedure in other cases

22.—(1) This section applies when—

(a)an application is made for the grant of a licence under this Part of this Act; and

(b)the appropriate committee—

(i)is not consulted under subsection (3) of section 20, or

(ii)is consulted under that subsection but does not give a provisional opinion in accordance with section 21(1).

(2) If the licensing authority propose—

(a)to refuse to grant the licence, or

(b)to grant it otherwise than in accordance with the application,

they shall notify the applicant of their proposals and the reasons for them.

(3) If the applicant is so notified, he may, within the time allowed—

(a)notify the licensing authority of his wish to appear before and be heard by a person appointed by the licensing authority with respect to the proposal; or

(b)make representations in writing to the licensing authority with respect to the proposal referred to in the notification.

(4) If the applicant makes written representations in accordance with subsection (3)(b) of this section, the licensing authority shall take those representations into account before determining the application.

Hearing before person appointed

22A.—(1) If the applicant gives notice under section 21(11) or section 22(3) of his wish to appear before and be heard by a person appointed by the licensing authority, the authority shall—

(a)make that appointment; and

(b)arrange for the applicant to have an opportunity of appearing before that person.

(2) The person appointed—

(a)shall not be, or at any time have been, a member of—

(i)the Commission on Human Medicines or any of its Expert Advisory Groups,

(ii)the Medicines Commission formerly established under section 2 of this Act or any of its committees, or

(iii)a committee established under section 4 of this Act, or any sub-committee of such a committee; and

(b)shall not be an officer or servant of any Minister of the Crown.

(3) Subject to subsection (4) of this section, the applicant shall provide the person appointed with—

(a)a written summary of the oral representations he intends to make; and

(b)any documents on which he wishes to rely in support of those representations,

before the end of the period of three months beginning with the date of the notice referred to in subsection (1) of this section.

(4) If the applicant so requests, the person appointed may, after consulting the licensing authority, extend the time limit referred to in subsection (3) of this section, up to a maximum period of six months beginning with the date of the notice referred to in subsection (1) of this section.

(5) If the applicant fails to comply with the time limit in subsection (3) of this section, or, where he has been granted an extended time limit under subsection (4) of this section, that time limit—

(a)he may not appear before or be heard by the person appointed, and

(b)the licensing authority shall decide whether to grant or refuse the licence, or to grant it otherwise than in accordance with the application, and notify the applicant accordingly.

(6) The applicant may not submit any additional written representations or documents once the time limit has expired, except with the permission of the person appointed.

(7) At the hearing before the person appointed, both the applicant and the licensing authority may make representations.

(8) If the applicant so requests the hearing shall be in public.

(9) After the hearing—

(a)the person appointed shall provide a report to the licensing authority; and

(b)the licensing authority shall take the report into account and decide whether to grant or refuse the licence, or to grant it otherwise than in accordance with the application, or to confirm or alter their decision, as the case may be.

(10) The licensing authority shall then—

(a)notify the applicant of their decision;

(b)if the applicant so requests, provide the applicant with a copy of the report of the person appointed.”.