Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what guidance the Medicines and Healthcare products Regulatory Agency provides on purchasing prescription-only medicines from overseas online providers for personal use.

The Medicines and Healthcare products Regulatory Agency (MHRA) enforces the Human Medicines Regulations 2012 but it does not hold responsibility for regulating the prescribing or retail supply of medicines, which sits across various sector and professional regulators. Regulators have the powers to take action against any services putting patients in danger.

The regulations establish that a person may not, except in accordance with a licence, manufacture, assemble or import a medicinal product or possess a medicinal product for the purposes of manufacturing, assembling or importing a medicinal product. However, this does not apply to a person who imports a medicinal product for administration to themselves or to any other person who is a member of that person’s household. This is commonly referred to as “personal imports” and applies to any medicinal product. This activity is thus not regulated by the MHRA and as a result no specific guidance has been issued by the agency.

In order to sell medicines in the European Union, 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 is no longer processing new applications for the Distance Selling Logo in Great Britain.