SCHEDULES
SCHEDULE 11Advice and representations
PART 1General procedures
Licensing authority decisions in other cases
12
1
This paragraph applies if the appropriate committee has not been consulted under paragraph 2(1) because the licensing authority proposes on grounds not relating to safety, quality or efficacy—
a
to refuse to grant or renew a UK marketing authorisation F1, parallel import licence or traditional herbal registration in response to the application;
b
to grant or renew a UK marketing authorisation F1, parallel import licence or traditional herbal registration otherwise than in accordance with the application; or
c
to revoke, vary or suspend a UK marketing authorisation F1, parallel import licence or traditional herbal registration.
2
This paragraph also applies if, having been consulted under paragraph 2(1), the appropriate committee has not given a provisional opinion in the terms described in paragraph 5(1), and the licensing authority proposes—
a
to determine the application for the UK marketing authorisation or traditional herbal registration in a way that differs from the appropriate committee's advice;
b
to revoke, vary or suspend the authorisation or registration against such advice; or
c
on grounds not relating to safety, quality or efficacy—
i
to refuse to grant or renew the authorisation or registration,
ii
to grant or renew the authorisation or registration otherwise than in accordance with the application, or
iii
to revoke, vary or suspend the authorisation or registration.
3
This paragraph also applies if the appropriate committee has not been consulted under paragraph 2(2) because the licensing authority proposes on grounds not relating to safety or quality—
a
to refuse to grant or renew a certificate of registration in response to the application;
b
to grant or renew a certificate of registration otherwise than in accordance with the application; or
c
to revoke, vary or suspend a certificate of registration.
4
This paragraph also applies if, having been consulted under paragraph 2(2), the appropriate committee has not given a provisional opinion in the terms described in paragraph 5(2), and the licensing authority proposes—
a
to determine the application for the certificate of registration in a way that differs from the appropriate committee's advice;
b
to revoke, vary or suspend the authorisation against such advice; or
c
on grounds not relating to safety or quality—
i
to refuse to grant or renew the certificate,
ii
to grant or renew the certificate otherwise than in accordance with the application, or
iii
to revoke, vary or suspend the certificate.
F34A
This paragraph also applies if, having been consulted under paragraph 2(2A), the appropriate committee has not given a provisional opinion in the terms described in paragraph 5(2A) and the licensing authority proposes to decide, against that committee's advice, that the orphan criteria are not met in relation to a medicinal product which is the subject of an application for the grant of a UK marketing authorisation.
5
The licensing authority must notify the applicant for the grant or renewal or (as the case may be) the holder of the authorisation F2, licence, certificate or registration in writing of its proposal.
6
The notification must state—
a
the reasons for the proposal; and
b
any advice of the appropriate committee and any reasons it has given for that advice.