EU-konsultasjon om logo for godkjente on-line-apotekutsalg og -engrosselgere av legemidler
Public consultation on the implementing act on a common logo for legally-operating online pharmacies/retailers offering medicinal products for human use for sale at a distance to the public
EU-konsultasjon igangsatt 17.10.2012 (frist 17.1.2013)
Nærmere omtale
BAKGRUNN (fra Kommisjonens konsultasjonsdokument, engelsk utgave)
1. On 1 July 2011, Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products was published. [1] This Directive amends Directive 2001/83/EC on the Community Code relating to medicinal products for human use. [2]
2. Directive 2011/62/EU introduces EU-wide rules in relation to 'the offer of medicinal products for human use for sale at a distance to the public by means of information society services' as defined in EU legislation. [3] For simplicity and clarity reasons, the term 'online pharmacy/retailer' shall be used for the purpose of this concept paper.
3. Directive 2011/62/EU introduces a "common logo" for websites of legally-operating online pharmacies/retailers. [4] This logo has to be clearly displayed on every page of the website offering the medicinal products.
4. The common logo shall be recognisable throughout the Union, while enabling the identification of the Member State where the online pharmacy/retailer is established. [5]
5. In addition, Member States are under an obligation to set up a dedicated website providing, inter alia, the national list of all legally-operating online pharmacies/retailers. [6]
6. Each entry of this list shall contain a hyperlink to the website of the respective online pharmacy/retailer.
7. In parallel, the common logo shall contain a hyperlink to the entry of the online pharmacy/retailer in the national list (reciprocal link) [7].
8. This reciprocal link is aimed to allow customers to verify the authenticity of the logo displayed on the webpage of the online pharmacy/retailer.
9. The Commission is under an obligation to adopt implementing acts [8] regarding:
• the technical, electronic and cryptographic requirements for verification of the authenticity of the common logo;
• the design of the common logo.
10. This concept paper is being rolled out for public consultation with a view to preparing the implementing act.
11. The adoption of the implementing act is scheduled for 2013.
[Footnotes]:
1 OJ L 174, 1.7.2011, p. 74
2 OJ L311, 28.11.2001, p. 67. A consolidated version of Directive 2001/83/EC including the amendments by Directive 2011/62/EU can be consulted on: http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2001L0083:20110721:EN:PDF
3 Title VIIA of Directive 2001/83/EC.
4 Article 85c(1)(d)(iii) of Directive 2001/83/EC.
5 Article 85c(3) of Directive 2001/83/EC.
6 Article 85c(4) of Directive 2001/83/EC.
7 Article 85c(1)(d)(iii) of Directive 2001/83/EC.
8 Article 85c(3) of Directive 2001/83/EC.
1. On 1 July 2011, Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products was published. [1] This Directive amends Directive 2001/83/EC on the Community Code relating to medicinal products for human use. [2]
2. Directive 2011/62/EU introduces EU-wide rules in relation to 'the offer of medicinal products for human use for sale at a distance to the public by means of information society services' as defined in EU legislation. [3] For simplicity and clarity reasons, the term 'online pharmacy/retailer' shall be used for the purpose of this concept paper.
3. Directive 2011/62/EU introduces a "common logo" for websites of legally-operating online pharmacies/retailers. [4] This logo has to be clearly displayed on every page of the website offering the medicinal products.
4. The common logo shall be recognisable throughout the Union, while enabling the identification of the Member State where the online pharmacy/retailer is established. [5]
5. In addition, Member States are under an obligation to set up a dedicated website providing, inter alia, the national list of all legally-operating online pharmacies/retailers. [6]
6. Each entry of this list shall contain a hyperlink to the website of the respective online pharmacy/retailer.
7. In parallel, the common logo shall contain a hyperlink to the entry of the online pharmacy/retailer in the national list (reciprocal link) [7].
8. This reciprocal link is aimed to allow customers to verify the authenticity of the logo displayed on the webpage of the online pharmacy/retailer.
9. The Commission is under an obligation to adopt implementing acts [8] regarding:
• the technical, electronic and cryptographic requirements for verification of the authenticity of the common logo;
• the design of the common logo.
10. This concept paper is being rolled out for public consultation with a view to preparing the implementing act.
11. The adoption of the implementing act is scheduled for 2013.
[Footnotes]:
1 OJ L 174, 1.7.2011, p. 74
2 OJ L311, 28.11.2001, p. 67. A consolidated version of Directive 2001/83/EC including the amendments by Directive 2011/62/EU can be consulted on: http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2001L0083:20110721:EN:PDF
3 Title VIIA of Directive 2001/83/EC.
4 Article 85c(1)(d)(iii) of Directive 2001/83/EC.
5 Article 85c(3) of Directive 2001/83/EC.
6 Article 85c(4) of Directive 2001/83/EC.
7 Article 85c(1)(d)(iii) of Directive 2001/83/EC.
8 Article 85c(3) of Directive 2001/83/EC.