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 competent authority of a member State in which the person named on the list is established;

“relevant website of the member State” means a website of the competent authority of a member State 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 member 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;

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

(a)

gives explicit information to the viewer on the relevant website of the member State containing information on persons authorised or entitled to supply medicinal products at a distance in that member State;

(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 hyperlinks to the relevant website of the member State.

[F3 (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 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)