Guidance

Export drugs and medicines: special rules

You must get permission to export certain drugs and medicines.

From:
Home Office, Veterinary Medicines Directorate and Medicines and Healthcare products Regulatory Agency
Published
11 November 2016
Last updated
19 March 2024 — See all updates

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.

For further information about exporting controlled drugs, see our controlled drugs guidance.

Drugs that can be used for lethal injections

If the product you are exporting contains a substance which could be used for lethal injections, your VMD export certificate scheme application must be supported by submitting an export licence issued by the Export Control Joint Unit (Department for Business and Trade (DBT)). This can be uploaded in the online application.

Follow the rules for exporting barbiturates.

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 - contact your importer or the authority in the destination country to find out

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 Certificate of a pharmaceutical product (licensed) application form (MS Word Document, 476 KB) and send it to MHRA. You can use the Certificate of a pharmaceutical product (licensed) guidance notes (MS Word Document, 83 KB) 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

Get a CPP for a centrally authorised product from 1 January 2021

The way you apply for a Certificate of Pharmaceutical Product (CPP) will not change from 1 January 2021, after the end of the transition period.

You’ll need to submit data about the product you’re applying for at least 2 days before you make your CPP application.

You must also email [email protected] to let them know when you’re about to make your first CPP application. You only need to do this once.

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 Certificate of a pharmaceutical product (unlicensed) application form (MS Word Document, 200 KB) and send it to MHRA. You can use the Certificate of a pharmaceutical product (unlicensed) guidance notes (MS Word Document, 72 KB) to help you fill in the form.

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 Certificate of manufacturing status application form (MS Word Document, 62.5 KB) and send it to MHRA. You can use the Certificate of manufacturing status guidance notes (MS Word Document, 52.5 KB) 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 Certificate of licensing status application form (MS Word Document, 87 KB) and send it to MHRA. You can use the Certificate of licensing status guidance notes (MS Word Document, 56 KB) 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 Certificate for the importation of a pharmaceutical constituent application form (MS Word Document, 52 KB) and send it to MHRA. You can use the Certificate for the importation of a pharmaceutical constituent guidance notes (MS Word Document, 54 KB) 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 email your application form

Send your application form to:

[email protected]

How much it costs

Fee How long it takes to get a decision
£75 10 working days
£167 2 working days

Make a payment to the MHRA using GOV.UK pay

Register of electronic export certificates

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 and holds a GMP certificate
  • 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.

Export Certificates are issued to you electronically by email.

On a Defra-1, Defra-3 or Defra-SFA certificate, if the named manufacturing site is situated in GB, the fee is £54. If the manufacturing site is situated in NI, the fee is £30.

On a Defra-2 certificate, if the product holds a UK wide marketing authorisation, or solely in GB, the fee is £54. If the product holds a marketing authorisation solely in NI, the fee is £30.

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 [email protected].

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.

For a Defra-2 certificate, please include up to 3 products in the schedule document.

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, but 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, but it does not independently verify any of the other information contained on this page

Updates to this page

Published 11 November 2016
Last updated 19 March 2024 + show all updates

  1. Fee cost's updated in the cost section.

  2. Removed details about applying for an export licence and linked to the controlled drugs page.

  3. Added: For a (VMD) Defra-2 certificate, please include up to 3 products in the schedule document.

  4. Updated department name from Department for International Trade (DIT) to Department for Business and Trade (DBT).

  5. Updated following documents: Certificate of a pharmaceutical product (licensed) application form - file attachment updated Certificate of a pharmaceutical product (licensed) guidance notes - file attachment updated Certificate of a pharmaceutical product (unlicensed) guidance notes - file attachment updated Certificate of manufacturing status application form - file attachment updated Certificate of manufacturing status guidance notes - file attachment updated Certificate of licensing status application form - file attachment updated Certificate for the importation of a pharmaceutical constituent guidance notes - file attachment

  6. Updated the payment info section to include the GOV.UK Pay payment platform

  7. Added new wording around getting a CPP for a centrally authorised product from 1 January 2021, after the transition period. This replaces a separate page which included the same content.

  8. Updated 5 export files/certificates

  9. We have updated 10 documents, adding an email address for invoicing.

  10. Updated email addresses to [email protected] and [email protected] (removing .gsi)

  11. VMD email address change

  12. Updated application forms and guidance notes.

  13. Changed MHRA address.

  14. First published.

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Contents

Part of Export goods from the UK: step by step

  1. Step 1 Check if you need to follow this process

    Follow these steps if you're moving goods permanently from:

    • England, Wales or Scotland (Great Britain) to a country outside the UK
    • Northern Ireland to a country outside the UK and the EU

    What you need to do is different if you are:

    1. Learn about exporting, including making export plans, on great.gov.uk

  2. Step 2 Check the rules for exporting your goods

    1. Check duties, rules and restrictions for your goods in the destination country

  3. and Apply for any licences you need to export your goods

    There are special rules and you may need to get licences or certificates if you are exporting any of the following:

  4. Step 3 Get your business ready to export

    You need an EORI number that starts with GB to export goods from England, Wales or Scotland.

    If you move goods to or from Northern Ireland you may need one that starts with XI.

    1. Get an EORI number
    1. Check if you need to register for VAT

    There are processes that can make clearing customs quicker and easier to manage if you export goods regularly.

    1. Find out about using simplified declaration procedures
    2. Check if you can use Common Transit to move your goods
    3. Check if Authorised Economic Operator status is right for you

  5. and Check whoever's receiving the goods can import them

    The business or person receiving the goods may need:

    • to make an import declaration in their country
    • licences or certificates to receive goods from the UK

    Check whoever you are sending the goods to is able to import them into their country.

  6. Step 4 Decide who will make export declarations and transport the goods

    You can hire someone to deal with customs and transport the goods for you, or you can do it yourself.

    1. Find out how to hire someone to deal with customs for you
    2. Find out how to make export declarations yourself
    3. Find out how to transport goods out of the UK by road

  7. Step 5 Classify your goods

    You must find the right commodity code to classify the goods you're exporting.

    Your customs agent or transporter might be able to help you with this.

    1. Find the right commodity code for your goods

  8. Step 6 Prepare the invoice and other documentation for your goods

    The completed invoice and any licences or certificates must travel with the goods.

    When filling in the value of your goods on the invoice, use the price you’re selling them for. If you're not selling the goods, use the market value of the goods. List any freight or export insurance you included in the price separately.

    You may need proof of origin if exporting to a country where your goods have a reduced or zero rate of duty.

    1. Get proof of origin for your goods

    You might be able to zero rate the goods for VAT. This means you can charge your customers VAT at 0%.

    1. Check if you can zero rate the goods for VAT

  9. Step 7 Get your goods through customs

    If you've appointed someone to deal with UK customs for you, they'll make the declaration and get your goods through the UK border.

    1. Make an export declaration and get your goods cleared by UK customs

    You may need other documentation to get your goods into the destination country. Ask the person or business buying your goods what information you need to provide.

    1. Check how to bring goods back into the UK if they were rejected for import at another country’s border

  10. Step 8 Keep invoices and records

    You must keep commercial invoices and any customs paperwork.

    If you're VAT registered, record the goods in your VAT accounts even if they are zero-rated.

    1. Find out how to record the goods in your VAT accounts

    If you exported controlled goods, for example firearms, keep the paperwork that shows who owns the goods.