Biotechnology and pharmaceuticals sector: international trade regulations

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Introduction

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

You need to know how to comply with export regulations if you plan to trade overseas, and meet all the requirements of importers, including how to comply with domestic regulations and the payment of tariffs and duties on imported goods. It will also help you access details of sector-specific issues of which you should be aware.

Export regulations for biotechnology and pharmaceuticals products

Regulations, charges or other restrictions may apply to biotechnology and pharmaceutical 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.

Find commodity codes and other measures applying to imports and exports in the life sciences sector by accessing our online trade tariff

The above tool will enable you to classify your goods. Using standardised classification codes makes it easier to check if any restrictions or charges apply.

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 with other EU countries without restriction. However, biotechnology and pharmaceutical products are likely to be exceptions.

Export licensing and certification

Pharmaceutical products tend to be restricted and stringent licensing requirements are applied. An export licence is required in order to export specified goods with military uses. You may require an export licence for dual-use goods which have a potential military use, eg components of chemical and biological weapons. Biotechnologists, for example, must comply with the export control regulations co-ordinated by the Department for Business, Innovation and Skills (BIS) Export Control Organisation.

Read about the Export Control Organisation.

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

Exporting goods for processing

You may be able to obtain relief from customs duties when you reimport 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 - or are incorporated into - the products being imported.

Before you can claim duty relief under OPR, however, you must have the appropriate authorisation. Read more in the guide on OPR.

Licensing for biotechnology and pharmaceutical products

If you export medicines, animals, animal products or plants and related materials, you need to be aware of specific licensing requirements.

If you deal in medicines - including veterinary medicines - within the EU, you must be licensed in the same way as for sales within the UK. If you export to countries outside the EU, you may need a licence to store products within the UK.

Exports of controlled drugs and precursor chemicals require additional licensing, which must be obtained online from the Home Office.

Launched in 2011, the online National Drugs Control System (NDS) administers the UK’s import and export licensing regime for controlled drugs and precursor chemicals. Run by the Home Office, NDS aims to speed up licence applications processing. You must register online to use NDS before you apply for a licence.

Register as a licensee to create a user account for controlled drugs and chemical licences.

Once you have completed registration process, import and export licence applications must be made online though the NDS portal. You will need to upload supporting documents, such as import permits from the destination country, to the system as well as to the Home Office’s drugs licensing and compliance unit (DLCU).

Export licences will be valid for up to 2 months, while import licences will be valid for up to 3 months.

Export controls on other products are administered by the regulatory bodies for each sector. For example, the MHRA Export Section licenses medicines for human use.

Contact the International Trade division of the Department for Environment, Food and Rural Affairs (Defra) to arrange health certification for animals and animal products. You can find more information about animal health certificates.

You can also obtain information for plants and related materials in the UK or the equivalent body in your country.

Any trade in products made from endangered plant and animal species must be accompanied by a licence. Read more about international trade in specimens of endangered species.

Researching your export destination for biotechnology and pharmaceutical products

When planning to export, you should thoroughly research your export destination country.

There are a number of issues that you ought to consider. As a starting point you may wish to seek advice from UK Trade and Investment (UKTI).

Find commodity codes and other measures applying to imports and exports in the life sciences sector by accessing our online trade tariff

You can also use the above tool to find out if your goods are affected by restrictions and charges at their destination country, together with all applicable duties and taxes. Key things to check include:

prohibitions or quotas on your products
import licensing restrictions
rates of duty payable when your goods enter your export market

You should also consider product safety and other technical standards in your export market. 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.

For a general guide to market information on sectors and countries, see the guide on researching and entering overseas markets.

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

your local UK Trade and Investment trade team
your UK Trade and Investment team within the commercial section of the UK embassy in your destination country
biotechnology and pharmaceuticals sector trade associations
the Chambers of Commerce in the UK and in your destination country

Tariffs and duties in the biotechnology and pharmaceuticals sector

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, duties and Intrastat and intellectual property.

Using the Integrated Tariff

A common customs tariff is applied across all EU countries on goods imported from outside the EU. Details of specific tariff duties and measures are contained in the Integrated Tariff of the UK.

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

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, as a result of which goods may attract preferential rates of duty.

Find out if your goods qualify for a preferential rate of duty and meet the appropriate rules of origin in Notice 828.

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.

See the guide on Intrastat: an overview.

Intrastat is the method of collecting information and producing statistics on goods traded between EU member states. See the guide on Intrastat - reporting the value and volume of intra-EU trade. Intrastat is only applicable to VAT-registered traders.

Intellectual property

You should ensure that imported goods do not breach the intellectual property rights of other businesses, eg watch out for counterfeit goods and patent infringements. Infringing goods in Europe can be seized and destroyed by HMRC or local customs authorities. You can ask HMRC to check for imported counterfeit versions of your goods. Read how HMRC can help protect your intellectual property rights in Notice 34.

Import regulations in the biotechnology and pharmaceuticals sector

As the EU is a customs union, you can 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 page VAT on goods from EU countries in the guide on imports and purchases from abroad: paying and reclaiming VAT.

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 imports from outside the EU.

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.

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.

Quite separately, quantitative restrictions or limitations and anti-dumping duties may apply to certain imported commodities.

For help identifying whether you require an import licence see the guide on import and export licences.

The trade in some goods may be prohibited unless you have a specific licence issued by the competent authority. If you import medicines, veterinary medicines or controlled drugs, you must be licensed in the same way as for sales within the UK. In some cases additional licensing is required. Check with the regulatory body in your sub-sector. Additional licences may be required for imports of:

medicines or unlicensed medicinal products
controlled drugs and precursors

Once you have completed the registration process, your licence applications must be made online though the NDS portal. You will need to supply supporting documents, such as the overseas trading partner addresses and preparations form, to NDS as well as supplying them to the Home Office. Import licences will be valid for up to 3 months.

Controls also exist for products of animal origin and plant material. Products:

of animal origin from within the EU must typically be accompanied by a health certificate
imported from elsewhere must be inspected at an approved border inspection post - read about animals and animal products international trade regulations
similar requirements apply to imports of plant material

Many pharmaceutical products can be imported without customs duty. The Tariff lists which products attract duty.

Goods imported to the UK must comply with domestic business standards. Find out which regulations and licences apply to the biotechnology and pharmaceuticals sector.

Transport regulations for dangerous goods (pharmaceuticals)

Many goods used in biotechnology and pharmaceuticals are potentially hazardous. You must ensure they are properly packaged and handled, and special documentation is required. Some types of goods are subject to particular rules, such as pesticides and biocides.

The requirements depend on the nature of the goods and how they’re being transported. For example, transport of oil by sea presents different pollution risks from transport by road or rail. Similarly, higher risks are associated with transporting, for example, chloroform by air than by road (where the container can be ventilated).

There are 3 broad sets of international regulations:

carriage of dangerous goods by road or rail
shipping dangerous goods
transport of dangerous goods by air

Key requirements generally include ensuring that goods are appropriately classified, packaged and labelled. It is also important that everyone involved understands how to minimise risks. Special training may be required.

In practice, you may use a specialist freight forwarder to handle your goods. However, it is still your responsibility to provide the right information to them. Completing a dangerous goods note is an effective way to do this for international shipments. See the section on the Dangerous Goods Note in the guide on transport document completion.

Sources of help and support in the biotechnology and pharmaceuticals sector

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

The government organisation with primary responsibility for providing trade support to UK exporters is UK Trade and Investment (UKTI). UKTI has an impartial global presence in countries throughout the world and helps businesses realise their international potential through knowledge transfer and ongoing partnership support.