F5PART 12ASale of medicines to the public at a distance

Annotations:
Amendments (Textual)
F5

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

Interpretation256A

F91

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 F1licensing authority;

  • F4...

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

    1. a

      gives explicit information to the viewer on the F2website of the licensing authority containing information on persons authorised or entitled to supply medicinal products at a distance in F8Northern Ireland;

    2. b

      provides information on the purpose of the common logo;

    3. c

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

    4. d

      provides information on Community legislation applicable to falsified medicinal products;

    5. e

      contains F6a hyperlink to the website of the licensing authority.

  • F3website of the licensing authority” means a website of the licensing authority providing information on—

    1. (a)

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

    2. (b)

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

    3. (c)

      the purpose of the common logo;

    4. (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;

    5. (e)

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

    6. (f)

      a hyperlink to the website of the EMA;

F72

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).