Register for the Distance Selling logo
Anyone in Northern Ireland selling medicines to the public via a website must still comply with the requirement to apply the EU common logo.
Overview
In order to sell medicines in the EU, EU-based online sellers must register, comply with relevant requirements and display an EU common logo linked to the competent authority of the country in which they are based.
From 1 January 2021 Great Britain (England, Wales and Scotland) based online sellers are no longer required to display the EU common logo (in the UK known as the Distance selling Logo).
Because of the Northern Ireland Protocol, anyone in Northern Ireland selling medicines to the public via a website must still comply with the requirement to apply the EU common logo. This means they must be registered with the MHRA and display a Distance Selling Logo on every page of the website offering medicines for sale.
For Great Britain the MHRA will be considering an alternative to the use of the Distance Selling Logo in the future.
The MHRA will continue to disrupt illegitimate online retailers through enforcement activity, and the MHRA will promote guidance to inform consumer choice when buying healthcare products online through public health campaigns across the UK.
The MHRA is no longer processing new applications for the Distance Selling Logo in Great Britain.
When to use the logo in Northern Ireland
The aim of the Distance Selling Logo is to help members of the public in Northern Ireland to identify anyone in Northern Ireland selling medicines via a website as a legitimate seller.
The Distance Selling Logo must be displayed on every web page that offers to sell medicines to the public in Northern Ireland.
If you are selling a medicine through a third-party marketplace website, you must include the Distance Selling Logo on each page of your listings where you offer medicines for sale to the public.
The European Commission has created technical guidance on using the logo.
The logo will be linked to a public register which can be checked by clicking on the logo on the page.
Check the register to see which websites are authorised by the MHRA to sell medicines online.
Selling medicines from the UK via the internet
If you are based in Northern Ireland and offer medicines for sale to the public in Northern Ireland or in a European Economic Area (EEA) country via a website, you must be registered with the MHRA. You must also be included in the MHRA’s list of Northern Ireland registered online retail sellers.
You must:
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display the Distance Selling Logo on the pages of the website that you use to offer the medicines
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provide the MHRA contact details
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provide a link to the MHRA website
You must also comply with the Electronic Commerce (EC Directive) Regulations 2002.
Registered pharmacies in Northern Ireland can sell general sales list medicines, pharmacy only medicines or supply licensed or unlicensed medicines that they have dispensed against a prescription. All other general retailers can only sell general sales list products.
All products sold or supplied by registered users of the Distance Selling Logo must be authorised for use in the destination European Economic Area (EEA) country. You can only sell or supply a medicine to a specific EEA country if it is authorised for use in that country. This means that the medicinal product being sold or supplied has to be the authorised product, in its authorised packaging and language as agreed in the product authorisation. In addition, some EEA countries do not allow medicines to be sold online in their country or they have other specific rules that apply. It is your responsibility to follow the law of the country that you are selling medicines to.
If you know, suspect or have reasonable grounds for knowing or suspecting that a medicine you are selling is falsified, then you must inform the MHRA immediately or where applicable the competent authority of another member state and the marketing authorisation holder of that medicine.
You can only get licensed medicines to be sold on a website from licensed manufacturers, importers and distributors in Northern Ireland, Great Britain or in an EEA country.
The registration process
A registration can only cover one company but more than one website can be registered to that company.
New applications can take up to 90 working days to process, excluding time taken to provide further information or data required. The MHRA will conduct checks to verify the information provided.
When the process is complete you will be sent a confirmation email including a link for downloading the Distance Selling logo.
If you are in Northern Ireland and sell or supply medicinal products at a distance to the Northern Ireland and EEA public online and you are registered with the MHRA, you will remain registered with the MHRA to sell medicines at a distance to members of the public.
Fees and payment
Application fees
Online sellers need to pay on application.
| Type of fee | Fee |
|---|---|
| Registration fee | £100 |
Annual renewal fees
Registration needs to be renewed annually, the annual charge is payable on 1 April of each year.
| Type of fee | Fee |
|---|---|
| Annual renewal fee | £97 |
Update MHRA on your websites
If you are in NI and sell or supply medicinal products at a distance to the NI and EEA public online, you should notify the MHRA of any changes to your registration details using the PCL portal.
You can use this register to check if a website is legally allowed to sell medicines to the public.
Remove your details from the register
To end your registration, submit a request using the PCL portal. Once you have been removed from the register you will not be allowed to sell any medicines online.
Legislation
The Distance Selling logo was brought in by the Falsified Medicines Directive.
The Falsified Medicines Directive is transposed into UK law through amendments to The Human Medicines Regulations 2012 [SI 2012/1916].
Report a suspicious website
Report a website if you think it is selling medicines illegally.
Further information
European Commission – EU logo for online sale of medicines
NHS Choices – Dangers of buying your medicines online
A guide for business to the Electronic Commerce (EC Directive) Regulations 2002 (SI 2002/2013)
Contact
- For queries relating to your DSL applications, please email dsl@mhra.gov.uk
- For all other queries please email MHRACustomerServices@mhra.gov.uk.
Last updated 21 December 2020 + show all updates
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Changes to the Distant Selling Logo from 1 January 2021.
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Guidance on supplying medicines online updated.
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Replaced 'interim arrangement for fees' with two sections: Application fees and Annual Renewal Fees.
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Updated information regarding upcoming renewal and application fees.
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First published.