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New UK Registration Requirements for Online Medicine Retailers

By Jane Summerfield & Amy Merrick on June 19, 2015
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From 1 July 2015, any UK-based online retailer that sells medicines to consumers in the UK or any EU or European Economic Area (EEA) country must be registered with the UK competent authority, the Medicines and Healthcare Products Regulatory Agency (MHRA). They must also display the EU common logo for online retailers and pharmacies, together with a hyperlink to the retailer’s entry in the MHRA’s list of registered retailers, on every page of the website that offers to sell medicines to the public. These requirements also apply to companies selling medicines through a third-party market place website.

Only one company can be named on each registration, but multiple websites can be registered against that company’s registration. The MHRA’s timeline for processing registration applications is 90 working days.

In the UK, registered pharmacies can sell general sales list and pharmacy (“over-the-counter”) medicines or supply prescription-only medicines dispensed against a prescription online. All other retailers can only sell general sales list medicines online. In addition, the medicines being offered online must be licensed in the EU Member State where the consumer purchasing that medicine is based.

The aim of the new requirements is to help the public check whether the website they are visiting can legally sell medicines and reduce the risk of buying counterfeit products.

The EU common logo was introduced under the Falsified Medicines Directive 2011/62/EU. The European Commission has published technical guidance on using the EU common logo: http://ec.europa.eu/health/files/eu-logo/logosancointernet_charte_v2.pdf
For further information on the UK requirements see: https://www.gov.uk/register-for-the-eu-common-logo

Photo of Jane Summerfield Jane Summerfield

Partner, London

Jane focuses on regulatory compliance and commercial agreements in the life sciences and food sectors. Jane advises on legal and regulatory requirements that apply during the product lifecycle, including clinical trial requirements, early access schemes, marketing authorisations, manufacturing and distribution licences…

Partner, London

Jane focuses on regulatory compliance and commercial agreements in the life sciences and food sectors. Jane advises on legal and regulatory requirements that apply during the product lifecycle, including clinical trial requirements, early access schemes, marketing authorisations, manufacturing and distribution licences, CE marking, product labelling, product composition, advertising and marketing activities, and pricing and reimbursement. Jane also advises on a wide range of commercial contractual arrangements, including consultancy, sponsorship, co-promotion, collaboration, manufacturing, distribution, services, quality and pharmacovigilance agreements, as well as helping clients to resolve issues with UK enforcement authorities and regulatory bodies, such as the Medicines and Healthcare products Regulatory Agency (MHRA), Prescription Medicines Code of Practice Authority (PMCPA), Advertising Standards Authority (ASA), Food Standards Agency (FSA) and Trading Standards.
Jane combines commercial acumen with deep regulatory knowledge. She understands the business pressures faced by clients, having provided in-house regulatory compliance and commercial support to a major pharmaceutical client and a multinational food company. Jane provides “clear responses with business impact” Chambers UK.

Read more about Jane SummerfieldEmail
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  • Posted in:
    Health Care and Life Sciences
  • Blog:
    Focus on Regulation
  • Organization:
    Hogan Lovells
  • Article: View Original Source

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