The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on...06 January 2017
COMMON EU LOGO FOR ONLINE PHARMACIES AND RETAILERS TO COME INTO EFFECT FROM 1 JULY 2015
The common EU logo has been established in accordance with Directive 2011/62/EU 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. Article 85c(1)(d)(iii) of Directive 2001/83/EC lays down the requirement for all legally-operating online purveyors of medicinal products to display an EU-wide recognisable logo on every webpage offering the concerned medicinal product.
Technical specifications of the logo
In practice, the harmonised logo is intended to ensure the accurate identification of the EU Member State where the online pharmacy or retailer is established. The technical specifications of the logo may be viewed in the technical paper on the Common EU logo for online pharmacies and retailers, as developed by the European Commission. The design of the logo has two important aspects: (i) The national flag of the relevant EU Member State must be placed on the left side of the logo; and (ii) A text which must be provided in the corresponding language of the EU Member State. The national flags of EEA states Norway, Iceland and Lichtenstein are also permitted. The use of the EU flag is, however, prohibited.
The presence of the logo on a webpage will not be sufficient to ensure that the online pharmacy or retailer is authorised. The verification of the logo must be executed through a reciprocal link. By clicking on the link, the national list of legally-operating online pharmacies and retailers must be accessible. This list will be provided by the competent authority of the concerned EU Member State.
Failure by on-line pharmacies to appropriately display the logo could result in a monetary penalty and/or a term of imprisonment which will be determined by EU Member States.
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