SCHEDULES
SCHEDULE 2Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019
PART 2Amendment of Part 3 (amendment of Part 3 (manufacture and distribution of medicinal products and active substances))
I114
In regulation 20 (amendment of Schedule 4 (standard provisions of licences under Part 3))—
a
for paragraph (2) substitute—
2
For paragraph 13(b) substitute—
b
in the case of a product for sale or supply—
i
in Great Britain, a UK marketing authorisation, certificate of registration or traditional herbal registration, or
ii
in Northern Ireland, a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration,
contains provisions relating to them,
b
after paragraph (2) insert—
2A
After paragraph 14 insert—
14A
A licence holder—
a
in Great Britain may only supply a special medicinal product to a person in Northern Ireland, and
b
in Northern Ireland may only supply a special medicinal product to a person in Great Britain,
in response to an order which satisfies the requirements of regulation 167.
c
for paragraph (3) substitute—
3
In the heading of Part 2, after “State Other Than an EEA State” insert
“ / Country other than an Approved Country for Import ”.
d
for paragraph (4) substitute—
4
In paragraph 15, for “from a state other than an EEA State” substitute—
from—
a
in the case of an import into Great Britain, a country other than Northern Ireland or a country other than an approved country for import, or
b
in the case of an import into Northern Ireland, a country other than an EEA State
4A
In paragraphs 22(1) and 23, for “a state other than an EEA State” substitute
“ , in the case of an import into Great Britain, a country other than Northern Ireland or a country other than an approved country for import and in the case of an import into Northern Ireland, a country other than an EEA State ”.4B
After paragraph 23, insert—
23A
A licence holder—
a
in Great Britain may only supply a special medicinal product to a person in Northern Ireland, and
b
in Northern Ireland may only supply a special medicinal product to a person in Great Britain,
in response to an order which satisfies the requirements of regulation 167.
e
for paragraph (6) substitute—
6
In paragraph 33, for “another EEA State” substitute
“ , in the case of an import into Great Britain, an approved country for import and in the case of an import into Northern Ireland, an EEA State ”.
f
after paragraph (6) insert—
7
After paragraph 41 insert—
41A
A licence holder—
a
in Great Britain may only supply a special medicinal product to a person in Northern Ireland, and
b
in Northern Ireland may only supply a special medicinal product to a person in Great Britain,
in response to an order which satisfies the requirements of regulation 167.