Who: Medicines and Healthcare products Regulatory Agency (MHRA)
Where: United Kingdom
When: 1 July 2015
Law stated as at: 9 July 2015
On 1 July 2015, the provisions of the Human Medicines Regulations 2012 relating to the sale of medicines to the public at a distance came into force. Those provisions transpose into UK law the requirements of the EU’s Falsified Medicines Directive. The aim of the legislation is to control and monitor both the quality and trade of medicines across the EU and to diminish the availability of falsified medicines within the EU.
The legislation requires all online retailers of medicines to the general public to register with the MHRA and to clearly display the “EU Common Logo” on websites offering medicinal products for sale; it also provides that any medicines sold online must be licensed in the purchaser’s respective Member State.
Registration with the MHRA
Any person in the UK, including registered pharmacies, that offers a human medicine for sale online to either a member of the public in the UK or to a member of the public in another Member State must be registered with MHRA.
Applications to register must be made via the PCL portal on the MHRA’s website and can take up to 90 working days to process, excluding any time taken to provide further information or data required by MHRA.
If the application for registration is successful, the person will be listed on the MHRA list of UK registered online retail sellers and will receive a link to download their registered EU Common Logo.
EU Common Logo
The Falsified Medicines Directive gave the European Commission a platform for developing a common logo which is recognisable throughout the EU and assists the public in identifying websites which are legally offering medicinal products for sale online.
The EU Common Logo (shown below) must be displayed on each webpage of a website offering medicinal products for sale and contains a hyperlink to the registered seller’s entry in the MHRA’s list of registered online sellers.
The EU Common Logo is different to the voluntary logo scheme administered by the General Pharmaceutical Council.
Consequences of non-compliance
The sanctions for selling medicines online to the public without registering with the MHRA, and for failing to display the EU Common Logo, are up to two years in prison and/or a fine.
However, the MHRA has recognised that, although the legislation came into force on 1 July, there may be a period of time between MHRA receiving the application for registration and the seller displaying the logo. It has stated therefore that it would not expect sellers to stop trading during that period, as long as they have submitted an application to MHRA.
Why this matters: This legislation introduces further compliance hurdles for online medicine retailers, in addition to having to comply with existing e-commerce and consumer protection legislation. They should ensure that, if they have not already done so, they submit their application for registration with the MHRA as soon as possible.