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The transposition of directive 2011/62/UE in United Kingdom

All retail pharmacies operating in the United Kingdom (UK) must be registered with the General Pharmaceutical Council (GPhC). The GPhC operates a voluntary internet pharmacy logo scheme to identify legitimate online pharmacies so that the public can be sure they are purchasing safe and genuine medicines online.
The logo not only provides a visual means to help patients identify whether a website is connected to a registered pharmacy, but it also provides a direct link to the GPhC website. By clicking on the logo, visitors can verify the registration details of both the pharmacy and the pharmacist(s) behind the website.
General sales list medicines can be sold online without any specific medicines regulatory controls.
 
What’s wrong with the current approach?
The GPhC registration and logo is voluntary and common to the UK. It does not apply to registered pharmacies in other parts of the European Union (EU).
 
Changes brought in by the directive
All persons offering medicinal products at distance should be registered and display the common logo recognised throughout the UK and European Economic Area (EEA).
The common logo [] is recognisable throughout the UE not just the UK, and allows for the identification of the Member State where the person offering medicinal products for sale at a distance is established. This logo has to be clearly displayed on the websites of persons in the UK who can legally offer medicinal products for sale at a distance to the public.
New measures require that any person offering a medicinal product to the public at a distance not only have to be entitled to supply medicinal products but also is required to notify to register their premises with appropriate authority.
The medicines that are supplied by way of distance selling are restricted to those that are authorised under the current regulatory framework for medicines, it will not be possible for a registered premises to offer unlicensed medicines online.
 
In addition to the provisions of the directive, national provisions have been introduced that allow the new registration regime to be appropriately operated. A registered person selling at a distance will therefore be subject to a procedure for:

  • consideration of applications for registration
  • de-registration
  • compulsory variation of their registration
  • suspension of their registration
  • revocation of their registration
  • an appeals procedure

 
These procedures reflect similar principles as to those which exist within an established licensing regime for medicines for human use.
 
The person selling medicines at a distance is required, if they suspect that they are handling a counterfeit medicine, to notify the authorisation holder of the products and the Medicines and Healthcare Products Regulatory Agency (MHRA).
The notified authority will also be required to set up a website providing at least the following:

  • information on the national legislation applicable to the offering of medicinal products for sale at a distance to the public by means of information society services, including information on the fact that there may be differences between Member States regarding classification of medicinal products and the conditions for their supply
  • information on the purpose of the common logo
  • the list of persons offering the medicinal products for sale at a distance to the public by means of information society services as well as their website addresses
  • background information on the risks related to medicinal products supplied illegally to the public by means of information society services
  •  
    Under these new requirements the role of the European Medicines Agency (EMA) is to coordinate the information and is required to set up a website providing information on the purpose of the common logo background, information on the risks related to medicinal products supplied illegally to the public by means of information society services, information on the Union legislation applicable to falsified medicinal products as well as hyperlinks to the authority’s’ websites.
    The EMA’s website will explicitly mention that the authority’s websites contain information on persons authorised or entitled to supply medicinal products at a distance to the public by means of information society services in the Member State concerned. The authority’s website will contain a hyperlink to the EMA’s website.
     

    Further information on the legislation:
    directive 2011/62/EU
    The Human Medicines Regulations 2012 n. 1916
    The Human Medicines (Amendment) Regulations 2013 n. 1855

    See also the MHRA web pages dedicated to the falsified medicines directive