Introduction

This guide provides an overview of the healthcare and medical sector, the key regulations you will need to comply with as an exporter or importer and selected sources of further help and support.

The guide outlines the sub-sectors of the healthcare and medical sector and looks at the strengths and key drivers of the industry.

You’ll find information on export licences and certificates and how to research an export country before trading. Importers can find out how to classify goods and what the tariffs, licences and intellectual property (IP) rights are.

In addition to regulations governing exports and imports, the guide provides access to a database of domestic regulations.

See the detailed guides for help with:

• classifying pharmaceutical products
• classifying placebos and comparators

Export regulations

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.

For more information, see the guides on:

• Dispatching your goods within the EU
• exporting your goods outside 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.

Learn how to classify your imports and exports using the UK Trade Tariff Tool.

Remember that in general it is much simpler to trade with other 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.

For more information about export licences for ‘strategic goods’ see UK Strategic Export Control Lists.

For information on export licences, read the guide on 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.

The Department for International Trade 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 about wholesale licences on the Medicines and Healthcare products.

Find guidance on exporting drugs and medicines: special rules.

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.

Find information about exports of controlled drugs.

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 the guide on 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.

Find information on Manufacturing, wholesaling, importing and exporting medicines.

Certificates of Free Sale

For medical devices, the importing country may require a Certificate of Free Sale, showing that the device meets UK standards.

The Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for the management of the Certificates of Free Sale (CFS).

Submit a request for a Certificate of Free Sale

Find out more about how to register for and use a Certificate of Free Sale.

Export 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 see the guide on outward processing relief (OPR).

For information on export licences, read the guide on import and export licenses.

Research your export destination

You should thoroughly research your export destination country when planning to export.

There are a number of issues that you ought to consider. As a starting point you may wish to seek advice from Department for International Trade (DIT).

Find your local DIT international trade advisor.

There are also various ways that you can research a potential export destination. These include trade associations.

You can use the UK Trade Tariff to check:

• special conditions such as prohibitions on your products
• licensing restrictions and requirements
• rates of duty payable when your goods enter your export market

You should consider product safety and medical and technical standards in your export market. For example, if you want to export a controlled drug, you will need a domestic licence before you can apply for an export licence. Your goods may need to be adapted to comply with these. Rules in your export market may be less or more strict than in the UK.

You should also be aware of any sanctions and embargoes which apply to your intended export destination. For more information see the guide on:

• current arms embargoes and other restrictions
• sanctions, embargoes and restrictions

You can ask for information about your export destination country from a range of organisations, including:

• your local DIT trade adviser
• your DIT team within the commercial section of the UK embassy in your destination country
• healthcare and medical sector trade associations
• the Chambers of Commerce in the UK and in your destination country

Department for International Trade (DIT) is a government organisation that supports UK businesses trading internationally and overseas enterprises seeking to set up or expand in the UK.

DIT has an impartial global presence in countries throughout the world and helps businesses realise their international potential through knowledge transfer and ongoing partnership support.

Tariffs and duties

There is a range of import-specific regulations that must be complied with by all businesses in this sector. The key issues relate to the Tariff, VAT and duties, and IP.

Use the Integrated Tariff

You can find details of specific tariff duties and measures are contained in the Integrated Tariff of the United Kingdom.

For more information on how the Integrated Tariff of the United Kingdom is important to your business, see the guide on an introduction to the Tariff.

The Tariff is used to determine the specific classification code of your goods, and to find out:

• any licensing requirements that apply
• the rates of duty and import VAT that apply
• any additional charges, such as anti-dumping duties
• any available preferential duty rates

Preferential rates of duty

The Generalised System of Preferences (GSP) allows products from a wide range of countries to be imported in the EU at a reduced or zero rate of duty.

The EC has a number of other preferential trade agreements with third countries, in which goods may attract preferential rates of duty. For instance, the EU duty on imports 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.

Find out if your goods qualify for a preferential rate of duty and meet the appropriate rules of origin.

Intrastat

If you are VAT registered and the goods you acquire from or supply to VAT-registered businesses in other EU countries reach the Intrastat exemption threshold for the year, you must submit monthly supplementary declarations to HMRC. Intrastat is the method of collecting information and producing statistics on goods traded between EU member states. Intrastat thresholds are reviewed annually.

See the guide on intrastat.

Intrastat is only applicable to VAT-registered traders.

Intellectual property

You should ensure that imported goods do not breach the IP rights of other businesses. For example, watch out for counterfeit goods and design infringements. Infringing goods can be seized and destroyed by HMRC. You can ask HMRC to check for imported counterfeit versions of your goods.

Read HMRC Notice 34: intellectual property rights to see how HMRC can help protect your IP rights.

For more information, see the guide on Protecting your UK intellectual property abroad.

In addition to checking the Tariff, you are advised to separately check the UK Strategic Export Control Lists if you intended to export controlled military or dual-use goods.

See the guide on the UK Strategic Export Control Lists.

Import regulations

As the EU is a customs union, member countries generally buy goods from other member countries without restrictions – although VAT and excise duty can still apply. For more information, see the guide on trading in the EU.

You can also see the guide on imports and purchases from abroad: paying and reclaiming VAT.

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 the guide on 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.

HMRC 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 1 tonne.

Read about REACH legislation on the Health and Safety Executive (HSE) website.

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.

For more information, see the guide on 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.

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 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.

Find out about importing unlicensed medicines.

Import licences for controlled substances

Additional requirements apply to imports of controlled substances such as opiates.

Find 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.

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 email the MHRA Enforcement Group at counterfeit@mhra.gov.uk.

Sources of help

As an importer or exporter in the healthcare and medical sector, you can turn to a range of bodies for help and information.

The government organisation with primary responsibility for providing trade support is Department for International Trade (DIT).

You can find information on the services DIT offers to exporters.

You can also find details of your local trade adviser.

Further information

Department of International Trade (DIT) Enquiry Line

020 7215 500

HMRC Tariff Classification Email Advice Service

Provision of non-legally binding tariff classification commodity codes advice is available through the Tariff Classification Service.

Medicines and Healthcare products Regulatory Agency (MHRA)

Services and information.

MHRA Enforcement Group (24 hours)

020 7084 2701

British Healthcare Trades Association Enquiry Line

020 7702 2141

Association of British Healthcare Industries Enquiry Line

020 7960 4360

Gambica Association for Instrumentation, Control, Automation & Laboratory Technology

020 7642 8080