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

Amendment of regulation 43 (obligations of licence holder)I133

1

Regulation 43 M1 is amended as follows.

F32

For paragraph (1), substitute—

43

1

The licence holder must comply with the guidelines on good distribution practice—

a

in the case of a licence holder in Great Britain, published under, or that apply by virtue of, regulation C17;

b

in the case of a licence holder in Northern Ireland, published by the European Commission in accordance with Article 84 of the 2001 Directive.

F43

For paragraph (5)(a) substitute—

a

in the case of a product for sale or supply—

i

in Great Britain, there is a UKMA(GB), UKMA(UK), a COR(GB), a COR(UK), a THR(GB) or a THR(UK) (an “authorisation”), or

ii

in Northern Ireland, there is a UKMA(NI), UKMA(UK), a COR(NI), a COR(UK), a THR(NI), a THR(UK), and EU marketing authorisation or an Article 126a authorisation (an “authorisation”),

in force in relation to the product; and

4

In paragraph (6)—

a

in sub-paragraph (a), insert at the end “ in the United Kingdom ”; and

F5aa

in sub-paragraph (b), after “the export” insert “from Northern Ireland”;

b

F7after sub-paragraph (b), insert—

F8ba

the export F9from Great Britain to an approved country for import, or supply for the purposes of such export, of a medicinal product which may be placed on the market in that country without—

i

a marketing authorisation, certificate of registration or traditional herbal registration within the meaning of the 2001 Directive, by virtue of legislation adopted by that country under Article 5(1) of that Directive, where the approved country for import is an EEA State, or

ii

such equivalent authorisation, certificate or registration in the approved country for import, under legislation in that country that makes provision that is equivalent to Article 5(1) of the 2001 Directive, where the approved country for import is not an EEA State.

F6c

for sub-paragraph (d) substitute—

d

the wholesale distribution of medicinal products—

i

from Northern Ireland to a person in a country other than Great Britain or a country other than an EEA State; or

ii

from Great Britain to a person in a country other than Northern Ireland or a country other than an approved country for import.

5

In paragraph (7)—

a

in sub-paragraph (b)—

F10i

for sub-paragraph (i) substitute—

i

ordered by the licensing authority or—

aa

in the case of a licence holder in Great Britain, by an appropriate authority for the licensing of medicinal products in an approved country for import;

bb

in the case of a licence holder in Northern Ireland, by the competent authority of any EEA State, or

F11ii

for sub-paragraph (ii) substitute—

ii

carried out in co-operation with the manufacturer of, or the holder of—

aa

in the case of a product for sale or supply in Great Britain, the UKMA(GB) or UKMA(UK), certificate of registration or traditional herbal registration, or

bb

in the case of a product for sale or supply in Northern Ireland, the UKMA(NI) or UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration,

for, the product; and

F12b

in sub-paragraph (c)(vii), before “the batch number” insert “where the receipt, dispatch or brokering of medicinal products takes places in Northern Ireland,”;

F15A

In paragraph (8)—

a

after “A licence holder” insert “in Northern Ireland”;

b

for “third country” substitute ““country other than an EEA State”.

6

F13After paragraph (8) insert —

F148A

F15Paragraph (8B) applies to a person (“P”) who—

a

imports F16into Great Britain a medicinal product, other than for the sole purpose of wholesale distribution of that product to a person in a country other than the United Kingdom; but

b

is not the holder of a UK marketing authorisation, certificate of registration or traditional herbal registration in respect of that product.

F148B

Where this paragraph applies, P must—

a

notify—

i

the holder of any authorisation, certificate or registration, granted by an authority in the country from which the product is exported, to sell or supply that product in that country, and

ii

the licensing authority,

of the intention to import that product; and

b

pay a fee to the licensing authority in accordance with the Fees Regulations.

F177

In paragraph (10), after “The holder” insert “of a licence relating to wholesale dealings in Northern Ireland”.

F188

In paragraph (13), for “marketing authorisation holder” substitute “UK marketing authorisation holder or EU marketing authorisation holder”.

F29

For paragraph (14) substitute—

14

Where the medicinal product is obtained through brokering—

a

a licence holder in Great Britain must verify that the broker involved fulfils the requirements set out in regulation 45A(1)(b);

b

a licence holder in Northern Ireland must verify that the broker involved is validly registered with the licensing authority or the competent authority of an EEA State.

10

In paragraph (15), after “In this regulation” insert “as it applies in the case of a product for sale or supply in Northern Ireland”.