January 23, 2022

Volume XII, Number 23

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January 21, 2022

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Mandatory Registration and Logo for UK Online Sales of Medicines

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.

© 2022 Covington & Burling LLPNational Law Review, Volume V, Number 204
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About this Author

Grant Castle, Life sciences lawyer, Covington Burling
Partner

Grant Castle is a partner in the London office practicing in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation.

His advice on general regulatory matters includes: adverse event and other reporting obligations, manufacturing controls, labeling and promotion, and product life cycle management.  He has also advised extensively on EC and national laws governing clinical research, data protection, and the regulatory status of borderline products.

44-20-7067-2006
Colin Warriner, Covington, intellectual property lawyer
Associate

Colin Warriner is an associate in Covington’s commercial technology practice, having joined the firm as a trainee solicitor in 2013.

Mr. Warriner’s practice covers a broad range of technology transactions, licensing agreements, commercial matters, and regulatory advice on privacy and data security, information technology, product liability, consumer protection, and intellectual property. He is a member of the firm’s Diversity Committee in London.

Mr. Warriner also has valuable in-house experience, following multiple secondments to the in-house legal...

44 20 7067 2189
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