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

Export regulations in the healthcare and medical sector

Regulations, charges or other restrictions may apply to healthcare and medical exports as they leave the UK and when they arrive at their destination country. It is important that you research both sides of the transaction.

Read more about exporting your goods from the EU to a third country and dispatching your goods within the EU.

First, you need to classify your goods. Use of standardised classification codes makes it easier to check if any restrictions or charges apply. For more information on how the Integrated Tariff of the United Kingdom is important to your export business, see an introduction to the Tariff.

You can use the Integrated Tariff of the United Kingdom to classify your goods. For more information, see our guide on classification of goods.

Access the UK Trade Tariff.

Remember that in general it is much simpler to trade with other European Union (EU) countries than with countries outside the EU. This is because the goods are in free circulation. The EU is a single market and the UK is in a customs union, so you can trade most goods, except medicines, with other EU countries without restriction (although some local charges may still apply).

In some countries preferential rates for export have been agreed. For instance, the EU duty on exports of certain medical equipment is zero as a result of the Uruguay Round of Multilateral Trade Negotiations agreed in 1994. Other countries where this deal is in force are the USA, Canada, Japan, Australia, New Zealand and South Korea.

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 (HMRC) runs the Authorised Economic Operator (AEO) scheme. While the scheme is not compulsory, companies that meet the requirements 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.

Export licensing and certification

An export licence is required to export specified goods with military or a potential military use. To determine if you need an export licence, you need to check the UK Strategic Export Control List which is a listing of controlled goods. The list of controlled goods includes materials, chemicals, 'micro-organisms' and 'toxins'.

On 16 April 2011, controls were also introduced on the export of specified pharmaceutical goods - potassium chloride, pancuronium bromide and sodium pentobarbital - to the USA. This follows controls placed on the export of thiopental sodium to the USA which came into force on 30 November 2010 and continue to be controlled. The relevant legislative order is the Export Control (Amendment) (No 3) Order 2011 (amending the Export Control Order 2008). These controls are in place due to the risk that the goods might potentially be used in the process of execution by lethal injection.

Read more about the Export Control Organisation.

For information on export licences, see: Do you need an export or import licence.

In addition to UK requirements, there are specific regulations that exporters in the healthcare and medical sector need to comply with to protect their business. These relate to the wholesaler dealer's licence, export licences for controlled substances, and Certificates of Free Sale. You will also need to find out the requirements of the country you are selling to, for instance, many medical devices should be CE-marked. Invest NI or your trade association may be able to help.

Wholesale dealer's licence

A licence is not generally required for exporting to countries outside the EU. However, you may require a licence if you store the products before exporting them. Find out more about wholesale licences.

Export licences for controlled substances

Additional requirements apply to exports of controlled substances such as opiates and nanotechnology. If you want to export a controlled drug, you will need a domestic licence before you can apply for an export licence. Read more about controlled drugs regulations. Similarly, export licences may be required where goods could be put to dual use or are exported to countries where sanctions are enforced. For information about countries where sanctions apply, see sanctions, embargoes and restrictions. For some substances, an import certificate from the country to which the substances are being exported is required before the Home Office will issue an export certificate.

For medicines and pharmaceutical components, many countries require an export certificate covering the product or its manufacturer. Export certificates are issued by the MHRA.

Certificates of Free Sale

For medical devices, the importing country may require a Certificate of Free Sale, showing that the device meets UK and European standards. These are issued by the Medicines and Healthcare products Regulatory Agency (MHRA). Medical equipment that contains radioactive materials may require additional certification. Find information on Certificates of Free Sale.

The Department for Business, Energy and Industrial Strategy (BEIS) also issues these certificates for some types of cosmetics and toiletries.

Exporting goods for processing

You may be able to obtain relief from customs duties when you re-import European Community (EC) goods that have previously been exported from the EC for processing. Outward Processing Relief (OPR) enables you to claim relief from customs duty if you can show that the exported goods were used in the products or are incorporated into the products being imported.

Before you can claim duty relief under OPR, however, you must have appropriate authorisation. For more information, read notice 3001 on OPR and see outward processing relief (OPR).

For information on export licences, see Do you need an export or import licence.