PART 3F1Manufacture and distribution of medicinal products and active substances
F2CHAPTER 2Manufacturing and wholesale dealing
Pt. 3 Ch. 2 heading inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 4
Grant etc of licences
Procedure where licensing authority proposes to suspend, revoke or vary licence27
1
This regulation applies where—
a
the provisions of regulation 28 do not apply; and
b
the licensing authority proposes to suspend, vary or revoke a licence under regulation 26.
2
The licensing authority must notify the licence holder in writing of—
a
its proposal;
b
the reasons for it; and
c
the date (which must be no earlier than 28 days from the notice given by the licensing authority) on which it is proposed that the suspension, revocation or variation should take effect.
3
The licence holder may before the date specified in the notice—
a
make written representations to the licensing authority with respect to the proposal; or
b
notify the licensing authority that the holder wishes the licensing authority to submit the proposal to review upon oral representations.
4
If the licence holder makes written representations in accordance with paragraph 3(a) the licensing authority must take those representations into account before making a decision in the matter.
F35
If the licence holder notifies the licensing authority that the holder wishes the licensing authority to submit the proposal to review upon oral representations in accordance with paragraph (3)(b)—
a
Schedule 5 has effect; and
b
the licence holder must pay a fee for a review upon oral representations in accordance with the Fees Regulations.
6
If the licensing authority proceeds to suspend, revoke or vary a licence in accordance with the provisions of regulation 26 it must give a notice to the licence holder.
7
The notice must—
a
give particulars of the suspension, revocation or variation; and
b
give reasons for the decision to suspend, revoke or vary the licence.
8
Paragraphs (6) and (7) are without prejudice to any requirement of Schedule 5 as to notification.
Pt. 3 heading and Pt. 3 Ch. 1 inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 4