Guidance

Export drugs and medicines: special rules

You must get permission to export certain drugs and medicines.

You need permission to export:

There’s a different process if you travel with controlled drugs for personal use. For example, taking medicine with you on holiday.

Some countries have import rules for certain goods. You can check by talking to your importer or getting help researching your export market.

Controlled drugs

Check the list of common controlled drugs.

If your drug is controlled, you need a Home Office controlled drug licence to export it. This is in addition to any domestic licence you need to possess the drug in the UK.

If your drug is not on the list but you think it might have the properties of a controlled drug, check the relevant legislation to find out if it’s controlled. The list of common controlled drugs has links to the relevant legislation.

Apply for an export licence

You need a Home Office controlled drug licence to export controlled drugs anywhere in the world.

To apply:

Your licence will be valid for up to 2 months (or until your import permit expires, if sooner).

There’s a different form if you’re exporting controlled drugs to the Channel Islands. Contact channel_islands@homeoffice.gsi.gov.uk for details.

Fees

The export licence costs £24.

The Drugs and Firearms Licensing Unit (DFLU) will send you a written invoice to the registered address on your customer account.

Help with controlled drugs

Contact DFLU if you need help.

Drugs and Firearms Licensing Unit
DFLU.ie@homeoffice.gsi.gov.uk
Telephone: 020 7035 6330
Find out about call charges

Drugs that can be used for lethal injections

Follow the rules for exporting barbiturates outside the EU.

Medicines

To export veterinary and human medicines you must:

  • check you have a drug manufacturer, wholesale dealer and marketing licence - if you don’t, apply for the licence
  • check if you need an export certificate outside the EU - contact your importer or the authority in the destination country to find out

You don’t need an export certificate within the EU.

You don’t need one of these licences to export ‘over the counter’ veterinary medicines classed as ‘AVM-GSL’. You can check classifications on the Veterinary Medicines Directorate (VMD) product information database.

If you need an export certificate, how you apply depends on whether you’re exporting:

There are additional rules if your medicine is coated in or contains animal products like gelatine.

Export certificates for medicines for humans

There are 5 types of certificate.

Which one you need will depend on the requirements of the importing country. Talk to the importer who’s receiving your goods to find out.

1. Certificate of a pharmaceutical product (licensed)

The certificate shows details including:

  • the marketing authorisation holder
  • the active ingredients and excipients
  • the manufacturing, packaging and batch release sites
  • whether or not the product is on the market in the UK

How to apply

Complete your application form (MS Word Document, 453KB) and send it to MHRA. You can use the guidance notes (PDF, 36KB, 8 pages) to help you fill in the form.

Or, use the MHRA portal to submit it.

You must also send a letter on headed paper from the marketing authorisation holder giving permission for you to export on their behalf. The letter should give permission for either:

  • the specific product or an open authorisation
  • all products the holder has a licence for

2. Certificate of a pharmaceutical product (unlicensed)

The drug must have been manufactured in the UK and you must have a manufacturer licence for the drug.

How to apply

Complete your application form (MS Word Document, 458KB) and send it to MHRA. You can use the guidance notes (PDF, 26.6KB, 4 pages) to help you fill in the form.

Or, use the MHRA portal to submit it.

You must also send a document on headed paper showing the formulation of the product and that it’s being manufactured on site.

3. Certificate of manufacturing status

Apply for a certificate of manufacturing status.

The certificate confirms the named sites on a specified manufacturer licence meet good manufacturing practice requirements. All or any of the sites named on the manufacture licence can be listed on the certificate.

The certificate won’t show any product specific information.

How to apply

Complete your application form (MS Word Document, 44KB) and send it to MHRA. You can use the guidance notes (PDF, 14KB, 1 page) to help you fill in the form.

Or, use the MHRA portal to submit it.

4. Certificate of licensing status

The certificate of licensing status is for importing agents who must screen bids made by an international tender for licensed or unlicensed products (excluding specials).

The certificate has a limit of 10 products and one country for each certificate.

The product name, dosage form, active ingredients and amounts should be the same as the medicine’s product licence (if it’s licensed).

How to apply

Complete your application form (MS Word Document, 354KB) and send it to MHRA. You can use the guidance notes (PDF, 14.7KB, 1 page) to help you fill in the form.

Or, use the MHRA portal to submit it.

5. Certificate for the importation of a pharmaceutical constituent

The specific active ingredient or excipient must be in either a:

  • current licensed human medicine
  • national or international pharmacopoeia (official standards for pharmaceutical substances and medicines)

The manufacturing site must hold a valid certificate of inspection from Medicines and Healthcare products Regulatory Agency (MHRA).

The certificate is country and ingredient specific. A certificate can only be for one site function, for example manufacture, packaging or batch release. You can apply for a certificate for each function.

How to apply

Complete your application form (MS Word Document, 36.5KB) and send it to MHRA. You can use the guidance notes (PDF, 11.5KB, 1 page) to help you fill in the form.

Or, use the MHRA portal to submit it.

You must send a letter on headed paper from the manufacturer confirming they’re the manufacturer.

Where to post or email your application form

Send your application form to either:

exports@mhra.gov.uk

or

Export Certificate Group, 5th Floor
The Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road
London
SW1W 9SZ

How much it costs

Fee How long it takes to get a decision
£68 10 working days
£152 2 working days

If your application is successful, you’ll get the original version of your certificate and 2 copies.

You can get extra copies of certificates for £34 each.

Export certificates for medicines for animals

There are 5 types of certificate.

Which one you need will depend on what you need to prove to the country you’re exporting to. Talk to the importer who’s receiving your goods to find out.

You can ask for extra information on the certificate if the importing country requires it.

Defra-2

The Defra-2 certificate and information that comes with it (the ‘schedule’) show that the export product is authorised for sale and supply in the UK.

Defra-1 and Defra-3

Both Defra-1 and Defra-3 show:

  • the product is manufactured in the UK
  • the product meets good manufacturing practice (GMP) requirements
  • the UK administrative address
  • the UK manufacturing site addresses
  • the authorised operations at the UK manufacturing sites

For Defra-1, you fill in a schedule that lets you give additional specific information about your export. You don’t have this option with Defra-3.

Defra-4

The Defra-4 certificate and the information that comes with it (the ‘schedule’), shows both:

  • the same things as in the Defra-1 and Defra-3 certificates
  • that active substances in your product are available in a UK-authorised product

Defra-SFA

The Defra-SFA certificate (and the ‘schedule’ information that comes with it) is for specified feed additives (SFA). It can show either:

  • the same things as in the Defra-1 and Defra-3 certificates
  • that your product is UK-authorised

Say which you’d like the certificate to show when you apply.

Apply for an animal medicine export certificate

For Defra-SFA, you have to apply by email.

For all other certificates:

You should get your certificate or be told why it hasn’t been issued within 10 days.

The fee is £30 (plus £15 for each certified copy, if you need these). You’ll get an invoice after you’ve applied.

The importing country may need more information about your export.

If you need extra information on the certificate

Some countries need information that is not on the standard certificates or schedule templates.

When you apply, you can ask for this information to be included for Defra-1, 2, or 4 certificates, but you must also include some standard wording in your application.

You can also ask for the following to be attached to your export documentation:

  • manufacturing authorisation
  • a summary of product characteristics (SPC) or product literature (or both)
  • a marketing authorisation certificate
  • Spanish or French versions of the ‘schedule’ documents

Other ways to apply

You can apply by emailing exportcert@vmd.defra.gsi.gov.uk.

Include:

  • a covering letter on headed paper
  • an email address for the invoice to be sent to
  • if you’re not the manufacturer, a letter from them giving permission for their details to be used in your application (Defra-1, 3 or 4 only)
  • a completed ‘schedule’ template (not required for Defra-3)

A schedule gives specific information about your export.

Download and fill in one of the following:

In the Defra-2 schedule, you can include that the product is ‘free from ingredients of a ruminant origin’ (if requested by the importing country). You must make it clear that the statement is made by you and not the VMD - ask them to verify the statement.

Standard wording

If you need extra information on the ‘schedule’ because the importing country requires it, you must also include the appropriate standard wording on every additional page.

Defra-1 and 4 wording:

The VMD stamp and signature on this page confirms the site is GMP compliant and holds a Manufacturing Authorisation. It does not independently verify any of the other information contained on this page. The Qualified Person at the site named on page one is responsible for the veracity and validity of the other information on this document.

Defra-2 wording:

The VMD stamp and signature on this page confirms the veterinary medicines named on the attached schedule hold a Marketing Authorisation in the same name. It does not independently verify any of the other information contained on this page.

Published 11 November 2016