PART 3Amendment of Part 3 (manufacture and distribution of medicinal products and active substances)

Amendment of Schedule 3 (applications for licences under Part 3)I118

1

Schedule 3 is amended as follows.

F22

For paragraph 1(2)(g) substitute—

g

the name, address, qualifications and experience of the person with responsibility for quality control in relation to the medicinal products to be manufactured or assembled under the licence (and, if that responsibility is to be carried out by the holder of—

i

in the case of a product for sale or supply in Great Britain, the UK marketing authorisation, certificate of registration or traditional herbal registration relating to the products, or

ii

in the case of a product for sale or supply in Northern Ireland, the marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration relating to the products,

a statement of that fact);

F33

For paragraph 2(1) substitute—

2

1

This paragraph applies to an application for a manufacturer’s licence relating to the import 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,

of medicinal products.

4

In paragraph 3—

a

in sub-paragraph (2)(d) at the end insert “ or the responsible person (import) ”.

b

in sub-paragraph (3)(b)—

F4i

for paragraph (i) substitute—

i

in the case of a product for sale or supply in Great Britain, a UK marketing authorisation,

ia

in the case of a product for sale or supply in Northern Ireland, a marketing authorisation,

F1ii

in paragraph (iv) before “an Article” insert “in the case of a product for sale or supply in Northern Ireland,”, and

iii

after paragraph (iii) insert—

v

an authorisation granted by an authority in a country other than the United Kingdom to sell or supply the medicinal product in that other country;

c

in sub-paragraph (3)(d)—

i

in paragraph (i) omit “or”,

ii

in paragraph (ii) for “etc);” substitute “ etc), or ”,

iii

at the end insert—

iii

to be distributed by means of export F5from Great Britain to an approved country for import;

d

for sub-paragraph (4) substitute—

4

In sub-paragraph (2)(d)—

  • “the responsible person” means the person who has the functions described in regulation 45(2);

  • “the responsible person (import)” means the person who has the functions described in regulation 45AA(4).