GovWire

Guidance: Export drugs and medicines: special rules

Home Office

October 5
07:20 2022

You need permission to export:

Theres 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 its 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).

Theres a different form if youre exporting controlled drugs to the Channel Islands. Contact channel_islands@homeoffice.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.gov.uk
Telephone: 020 7035 6330
Find out about call charges

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 International Trade). 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 dont, 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 dont 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 youre 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 whos 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.

Youll need to submit data about the product youre applying for at least 2 days before you make your CPP application.

You must also email exports@mhra.gov.uk to let them know when youre 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 produc

Related Articles

Comments

  1. We don't have any comments for this article yet. Why not join in and start a discussion.

Write a Comment

Your name:
Your email:
Comments:

Post my comment

Recent Comments

Follow Us on Twitter

Share This


Enjoyed this? Why not share it with others if you've found it useful by using one of the tools below: