Part II Licences and Certificates Relating to Medicinal Products

C3Applications for, and grant and renewal of, licences

Annotations:
Modifications etc. (not altering text)
C3

Definitions in ss. 18-22 applied (N.I.) (1.4.1992) by S.I. 1991/194 (N.I. 1), art. 7(2), Sch. 2 para. 5(4); S.R. 1991/131, art. 2(e), Sch. Pt.III

C224 Duration and renewal of licence. C1

1

Subject to the following provisions of this section, every licence granted under this Part of this Act, unless previously renewed or revoked, shall expire at the end of the period of five years from the date on which it was granted or the date as from which it was last renewed, as the case may be, or at the end of such shorter period from that date as may be specified in the licence as granted or last renewed.

F1(1A) Where any licence has been granted under this Part of this Act and the licensing authority subsequently consider that it would no longer be possible to grant that licence without contravening a Community obligation F2(other than an obligation under F3Title V of the 2001 Directive), the licence shall (notwithstanding subsection (1) above) expire on such date as may be specified in a notice served on the holder of the licence by the licence authority.

2

Any F4licence granted under this Part of this Act, if it has not been revoked, may, on the application of the holder of the licence, be renewed by the licensing authority for a further period of five years from the date on which it would otherwise expire or such shorter period from that date as the licensing authority may determine.

3

On an application to the licensing authority for the renewal of a licence under this Part of this Act, the licensing authority—

a

may renew the licence, with or without modifications, for such a further period as is mentioned in subsection (2) of this section, or

b

may grant to the applicant a new licence containing such provisions as the licensing authority consider appropriate, or

c

if, having regard to the provisions of this Act F5and any Community obligation under F6the 2001 Directive other than Titles VI, VII and VIII of that Directive, they consider it necessary or expedient to do so, may refuse to renew the licence or to grant a new licence.

4

In relation to any such application the provisions of sections 18 and 19, subsections (2) to (5) of section 20 and sections 21 and 22 of this Act shall have effect as if in those provisions any reference to refusing a licence included a reference to refusing to renew a licence and any reference to granting a licence included a reference to renewing it.

5

Every application for the grant or renewal of a licence under this Part of this Act shall, unless it otherwise expressly provides, be taken to be an application for the grant or renewal of the licence for the full period of five years mentioned in subsection (1) or subsection (2) of this section, as the case may be; and in this Part of this Act any reference (including a reference implied by virtue of the last preceding subsection) to the grant or renewal of a licence otherwise than in accordance with the application shall be construed accordingly.

6

Where an application for the renewal of a licence under this Act has been duly made—

a

the licence shall not cease to be in force by virtue of the preceding provisions of this section before the licensing authority have determined the application, and

b

if by an interim order made under section 107(3)(a) of this Act the operation of the decision of the licensing authority on the application is suspended, the licence shall not cease to be in force by virtue of those provisions so long as the operation of the decision continues to be suspended by the order.

F77

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