The Human Medicines Regulations 2012

[F1 Interpretation U.K.

256A.— [F2 (1)] In this Part—

“common logo” means the common logo that is required to be clearly displayed on websites offering medicinal products for sale at a distance to the public in accordance with the requirements laid down in the implementing acts adopted by the Commission under Article 85c(3) of the 2001 Directive;

“information society services” means information society services as defined in Article 1(2) of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services;

“the list” means the list of persons who are entitled to supply medicinal products by information society services that is maintained on the website of the [F3 licensing authority];

F4 ...

“website of the EMA” means the website of the EMA that—

(a)

gives explicit information to the viewer on the [F5 website of the licensing authority] containing information on persons authorised or entitled to supply medicinal products at a distance in [F6 Northern Ireland];

(b)

provides information on the purpose of the common logo;

(c)

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

(d)

provides information on Community legislation applicable to falsified medicinal products;

(e)

contains [F7 a hyperlink to the website of the licensing authority].

[F8 “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;]

[F9 (2) In this Part, references to selling a medicinal product at a distance to the public by means of information society services, however expressed, include supplying and offering to sell or supply a medicinal product at a distance to the public by means of information society services (and related expressions are to be interpreted accordingly).]]

Textual Amendments

F1 Pt. 12A inserted (coming into force in accordance with reg. 1(2) of the amending S.I.) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(2), 28

F2 Reg. 256A renumbered as reg. 256A(1) (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 13(a) and reg. 256A renumbered as 256A(1) (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 13(a)

F3 Words in reg. 256A(1) substituted (31.12.2020) by S.I. 2019/775, reg. 197(2)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)

F4 Words in reg. 256A(1) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 197(2)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)

F5 Words in reg. 256A(1) substituted (31.12.2020) by S.I. 2019/775, reg. 197(2)(d)(i)(aa) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)

F6 Words in reg. 256A(1) substituted (31.12.2020) by S.I. 2019/775, reg. 197(2)(d)(i)(bb) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)

F7 Words in reg. 256A(1) substituted (31.12.2020) by S.I. 2019/775, reg. 197(2)(d)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)

F8 Words in reg. 256A(1) inserted (31.12.2020) by S.I. 2019/775, reg. 197(2)(c) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 151)

F9 Reg. 256A(2) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 13(b) and reg. 256A(2) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 13(b)