Part II Licences and Certificates Relating to Medicinal Products
C5Applications for, and grant and renewal of, licences
C2C3C4C6F1 22 Procedure in other cases. C1
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.
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