Amendment of Part 12A197

1

Before regulation 256A (interpretation) insert—

Application of Part256ZA

This part applies to Northern Ireland only.

2

In regulation 256A(1) (interpretation)—

a

in the definition of “the list”, for “competent authority of a member State in which the person named on the list is established” substitute “ licensing authority ”;

b

omit the definition of “relevant website of the member State”;

c

at the appropriate place in the alphabetical order insert—

“website of the licensing authority” means a website of the licensing authority providing information on—

a

the national legislation applicable to the offering of medicinal products for sale at a distance to the public by information society services;

b

the differences between Northern Ireland and EEA States regarding classification of medicinal products and the conditions for their supply;

c

the purpose of the common logo;

d

the list of persons offering medicinal products for sale at a distance by means of information society services as well as their website addresses;

e

background information about the risks related to medicinal products supplied illegally to the public by means of information society services;

f

a hyperlink to the website of the EMA;

d

in the definition of “website of the EMA”—

i

in paragraph (a)—

aa

for “relevant website of the member State” substitute “ website of the licensing authority ”;

bb

for “that member State” substitute “ Northern Ireland ”;

ii

in paragraph (e), for “hyperlinks to the relevant website of the member State” substitute “ a hyperlink to the website of the licensing authority ”.

3

In regulation 256B (person who may sell medicinal products by information society services)—

a

before paragraph (1) insert—

A1

This regulation applies to a person who is an established service provider (as defined in regulation 2(1) of the Electronic Commerce (EC Directive) Regulations 2002 M1) in Northern Ireland.

b

in paragraph (2), omit “of persons selling medicinal products at a distance that is published on the relevant website of the member State”;

c

for paragraph (3) substitute—

3

Condition B is that the product to be sold by information society services is covered by a UK marketing authorisation or an authorisation granted—

a

under Regulation (EC) No 726/2004; or

b

by a competent authority of the member State in which that product is destined to be sold.

3A

Condition B does not apply to—

a

a special medicinal product;

b

a medicinal product where the product is the result of a process of manufacture to which regulation 17(1) does not apply by virtue of any provision of section 10 of the Medicines Act 1968 M2; or

c

a medicinal product where—

i

the product is a result of a process of assembly of a medicinal product that is an authorised medicinal product within the meaning of regulation 3(15);

ii

regulation 17(1) does not apply to the process of assembly by virtue of any provision of section 10 of the Medicines Act 1968;

iii

the process of assembly results in a change in the presentation of the authorised medicinal product; and

iv

by reason of the change in paragraph (iii) the product does not comply with condition B.

d

in paragraph (4), omit “in the member State in which that person is established”;

e

in paragraphs (6), for “the competent authority in a member State in which the person is established” substitute “ the licensing authority ”;

f

in each of paragraphs (8)(b) and (c), for “the competent authority of a member State” substitute “ the licensing authority ”.

4

In regulations 256C (notification requirements for sellers of medicinal products at a distance) to 256M (offences: breach of regulations and false information), for “competent authority of a member State” in each place it occurs (including in the headings to regulations 256F and 256J) substitute “ licensing authority ”.

5

In regulation 256C (notification requirements for sellers of medicinal products at a distance), in paragraph (2)(b)(iv), for “informantion” substitute “ information ”.

6

In regulation 256D(3) (procedure for listing persons who may supply medicinal products at a distance), for “that competent authority” in both places substitute “ the licensing authority ”.

7

In regulation 256G (grant or refusal to list a person)—

a

in paragraph (2), for “that competent authority” substitute “ the licensing authority ”;

b

in paragraph (3)—

i

for “that competent authority” substitute “ the licensing authority ”;

ii

for “relevant website of the member State” substitute “ website of the licensing authority ”.

8

In regulation 256H(3) (conditions to be met by a person entered on the list)—

a

in sub-paragraph (a), omit “which is responsible for maintaining the list on which the person selling products at a distance is included”;

b

in sub-paragraph (b), for “relevant website of the Member State” substitute “ website of the licensing authority ”.

9

In regulation 256J (procedure where the licensing authority proposes to suspend, vary or remove a person's entry on the list), omit sub-paragraph (6)(b) (and the “and” at the end of sub-paragraph (a)).

10

In regulation 256K(1) (suspension of a person's entry on the list in cases of urgency), for “that competent authority” substitute “ the licensing authority ”.

11

In regulation 256L (variation of a person's entry on the list on the application of that person)—

a

in paragraph (3), for “that competent authority” substitute “ the licensing authority ”;

b

in paragraph (6)(b), for “that competent authority's” substitute “the licensing authority's”.