Guide

International trade regulations in the Life Sciences - healthcare and medical sector

Import regulations in the healthcare and medical sector

As the European Union (EU) is a customs union, you can generally buy goods from other member countries without restrictions - although VAT and excise duty can still apply. Read more about trading in the European Union. For medicines, however, you will need at least one licence.

If you import from outside the EU, you may have to comply with import licensing requirements and with common customs tariffs that apply across the EU. For more information, see importing your goods from outside the EU.

The European Commission has identified the need to secure supply chains for goods leaving and entering the EU. However, increased customs checks may be likely to lead to delays in journey times for consignments, and possibly longer shipping lead times.

HM Revenue & Customs runs the Authorised Economic Operator (AEO) for business. While the scheme is not compulsory, companies that meet the requirements of the scheme will be registered as AEOs and can take advantage of simplified customs procedures that relate to the security and safety of their goods in transit.

Import licences

Under Registration, Evaluation, and Authorisation of Chemicals (REACH) legislation, importers or manufacturers of more than one tonne of chemicals a year must register with the European Chemicals Agency and build an inventory of every chemical that comes into, is part of, or goes out of the business. Traded products must be labelled and packaged according to specific rules. Importers must establish if any substance (which is intended to be released under normal or reasonably foreseeable conditions of use) is present in these articles in quantities totalling over one tonne.

Read more about REACH legislation.

Import restrictions can be product-specific or trade-specific. Many products are subject to product-specific standards and need to be supported by applicable certificates, product-specific licences and documentation.

Restrictions or limitations on the quantity of some imports mean that you may have to pay anti-dumping duties on your goods. Read more about anti-dumping and countervailing duties.

You can check the Tariff to see if your goods will be subject to these and other licences. The Tariff is a customs document which shows commodity codes, licences, duties, taxes and other measures to classify all goods for import and export. You can find out more by reading an introduction to the Tariff.

Access the UK Trade Tariff.

The trade in some goods may be prohibited unless you have a specific licence issued by the competent authority. These include wholesale dealer's licences and product licensing and approval.

Wholesale dealer's licence

If you purchase medicines from other countries within the EU, you must have a wholesale dealer's licence. If you import medicines from outside the European Economic Area, you must also have a wholesale dealer's import licence.

Licences are issued by the Medicines and Healthcare products Regulatory Agency (MHRA).

These licences allow you to import both licensed and unlicensed medicinal products. However, you must notify the MHRA before importing unlicensed products and can only supply them to meet the special needs of an individual patient.

Import licences for controlled substances

Additional requirements apply to imports of controlled substances such as opiates. Find more information about imports of controlled drugs.

Product licensing and approvals

Imported medicines and medical devices can only be sold in the UK if they meet UK requirements.

Medical devices that are imported from another EU country where they are approved for sale automatically meet UK requirements. Medicines that are already licensed in other EU states still need UK licensing, but can be licensed under the simpler parallel import licensing scheme. Read more about parallel import licences.

Where goods are imported from outside the EU, the importer must put the product through the appropriate licensing or approval process. However, it may be possible to simplify this process for medical devices that originated from within the EU. For example, the supplier might be able to provide the original Certificate of Free Sale showing that EU requirements have been met.

Goods imported to the UK must comply with domestic business standards, including a licence to manufacture and distribute medicines, approval of medical devices by notified bodies, and CE marking of medical devices.

Fake medicines

If you order medicines to import online, be aware that many drug websites originate outside the UK and are not regulated by UK authorities. This means that your business is at risk of receiving substandard or fake medicines. All retail pharmacies in Great Britain, including those providing internet services, must be registered with the Royal Pharmaceutical Society of Great Britain.

Traders with concerns about counterfeit medicines and devices can e-mail the MHRA Enforcement Group at counterfeit@mhra.gov.uk.