Paragraph 14 I1

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,”.”;

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.”.”;

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 ”.”;

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.”.”;

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 ”.”;

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.”.”.