By Colin Warriner

Since 1 July 2015, anyone in the UK selling medicines online to the general public must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA), and be on the MHRA’s list of UK registered online retail sellers.  In addition, those retailers now need to display, on every relevant page of their websites, the new EU common logo, which will hyperlink directly to the MHRA’s list of registered online sellers.  The MHRA has issued guidance on registration and the use of the logo.

MHRA Registration

A company wishing to register with the MHRA to sell medicines online to the general public should do so through the MHRA Process Licensing Portal.  Each registration can cover one company, but multiple websites.  There is currently no fee to register, but the MHRA has said that it will consult on fee proposals later in 2015, with the aim of recovering the costs of administering the logo scheme.

Registration of new applications can take up to 90 working days (excluding time taken to respond to queries), but since the portal opened on 16 June 2015, the MHRA has adopted a pragmatic approach: it has said that it does not expect sellers to stop trading during the period between MHRA receiving an application and the seller displaying the EU common logo.  Once a company has completed the registration process, the MHRA will send them a link for downloading the EU common logo.

EU common logo

The UK has transposed the Falsified Medicines Directive (2011/62/EU), which established the EU common logo, through amendments to the Human Medicines Regulations 2012 (SI 2012/1916).  The aim of the logo is to help members of the public identify websites that can legally sell medicines, and therefore reduce the risk of falsified medicines entering the market or harming buyers.  When announcing the scheme in June 2015, Lynn Scammell, senior policy advisor at the MHRA said: “The new logo scheme should provide people buying medicines online with the reassurance that they are buying from a legitimate site.  People will be able to click through to a list of registered sellers so they know the site is properly registered.  Buying from an unregistered site could mean you do not know what medicines you are getting, and you could even be damaging your health.” The EU Commission has issued technical guidance on using the logo.

While the General Pharmaceutical Council (GPhC) has for some time operated a voluntary internet pharmacy logo scheme for registered pharmacies to help reassure patients and the public in the UK, displaying the EU common logo is now a legal requirement.  All companies based in the UK and offering medicines for sale to the public in the UK or in another European Economic Area country via a website must ensure they comply or risk a penalty.  Failing to display the logo as required is an offence punishable with a fine or up to two years’ imprisonment.

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Photo of Grant Castle Grant Castle

Grant Castle is a partner in London and Dublin practicing in the areas of EU, UK and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law litigation…

Grant Castle is a partner in London and Dublin practicing in the areas of EU, UK and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law litigation matters in the EU, UK, and Irish Courts.

He is one of the Co-chairs of Covington’s Life Sciences Industry Group and is Head of Covington’s European Life Sciences Regulatory Practice.

Grant regularly advises on:

  • EU and UK regulatory pathways to market for pharmaceuticals and medical devices, including in vitro diagnostics and on associated product life cycle management;
  • Pharmaceutical GxPs, including those governing pharmacovigilance, manufacturing, the supply chain and both clinical and non-clinical research;
  • Medical device CE and UKCA marking, quality systems, device vigilance and rules governing clinical investigations and performance evaluations of medical devices and in vitro diagnostics;
  • Advertising and promotion of both pharmaceuticals and medical devices; and
  • Pricing, reimbursement and market access for both pharmaceuticals and medical devices.

Grant also handles procedural matters before EU, UK and Irish regulators and UK and Irish market access bodies, where necessary bringing judicial reviews for his life sciences clients before the EU, UK and Irish Courts.

Chambers UK has ranked Grant in Band 1 for Life Sciences Regulatory for the last 18 years. He is recognized by Chambers UK, Life Sciences as “excellent,” “a knowledgeable lawyer with a strong presence in the industry,” who provides “absolutely first-rate regulatory advice,” according to sources, who also describe him as “one of the key players in that area,” whilst Chambers Global sources report that “he worked in the sector for many years, and has a thorough understanding of how the industry ticks.” He is praised by clients for his “absolutely first-rate” European regulatory practice. Legal 500 UK notes that he is “highly competent in understanding legal and technical biological issues.”