Exporting medicines has never been more lucrative.
From herbal products to generic drugs, the global manufacturing and export of pharmaceutical products continue to reach newfound gargantuan heights.
Over the past two decades, the pharma industry’s revenues worldwide grew up to a whopping 1.42 trillion U.S. Dollars in 2021. The global pandemic was fuel to the fire as governments across the world bulk bought pharmaceutical products.
It’s clear that the foreign trade of pharmaceutical products is booming. It’s more important than ever before that every pharma export company has the necessary documents in place to streamline customs clearance.
In this article, we highlight what type of drugs require permission to export, and the sort of pharma export documentation you are required to provide before you are allowed to export.
This article at a glance
Any company that wants to export pharmaceutical products overseas may require an export licence — in effect, permission to export certain drugs and medicines. Depending on the type of pharmaceutical product you export, you will need to fill out the right export certificate or face a penalty.
Foreign trade is bound by bureaucracy — anyone looking to export goods has to fill out paperwork.
Exporting pharmaceutical products is no different.
There are certain documents required for the export of pharmaceutical products.
An exporters licence or certificate is critical — this acts as permission to export pharmaceutical products and will smoothen customs clearance.
3 common scenarios where you will require permission in the UK include the following:
Keep in mind that the above only applies if you are an exporter shipping large or bulk pharmaceutical products to other countries. Personal drug usage does not fall under the above rules.
First things first: know your HS code. The Harmonised System (HS) is an internationally-recognised import-export code that classifies goods based on type. The HS Code enables customs authorities to control the flow of goods into their home country and levy the correct tax.
This is particularly important for controlled goods, like pharma products, and helps the importing country know what goods they’re receiving.
In short, it’s one of those important freight details to get right and ensures smooth customs clearance.
If you are unsure of what constitutes a controlled drug, check out this list of the most commonly encountered drugs currently controlled under the misuse of drugs legislation in the UK.
You will require both:
Every pharmaceutical exporter needs a Home Office-controlled drug licence to export controlled drugs anywhere in the world. Here’s how to apply for one.
Your licence will be valid for up to 2 months or until your import permit expires, whichever is sooner. Note that the export of controlled drugs to the Channel Islands will require you to contact channel_islands@homeoffice.gov.uk.
The Home Office controlled drug licence costs £24. You will receive a written invoice to your registered address from the Drugs and Firearms Licensing Unit (DFLU).
To export pharma products that can be used in lethal injections, you will require the following:
The rules and steps for exporting these drugs are similar to those relating to the exporting of torture and capital punishment goods (barbiturates) and are controlled by the Torture Goods Regulations.
Before you apply for any licence, ensure that your drugs do not fall under this category: drugs that have no practical use other than capital punishment, torture and other cruel, inhuman or degrading treatment or punishment.
You will never be able to export those drugs, as they are strictly prohibited, except in specific circumstances.
However, you may be allowed to export these two categories of drugs through an export licence:
In other words, if you plan to export drugs that can be used in lethal injections, you must ensure that they serve other purposes other than simply being a form of punishment. For a list of goods that are prohibited and those that require export authorisation, check out this link.
Here’s how you can apply for an export licence for drugs used in lethal injections:
For more detailed information, refer to this guide.
You must hold a drug manufacturer, wholesale dealer and marketing licence and an export certificate if you wish to export veterinary and human pharmaceutical products.
Keep in mind that you will not need the above licences to export over-the-counter veterinary medicines classed as ‘AVM-GSL'. Here’s a list of veterinary medicines included in the Veterinary Medicines Directorate (VMD).
If your medicine is coated in or contains animal products such as gelatine, follow these additional rules.
There are two situations: exporting medicine for humans and medicine for animals.
You do not need to apply for all five certificates. The one you need will depend on the importing country’s requirements. Contact your importer to find out more.
Certificate and what is covered
1. Certificate of a pharmaceutical product (licensed)
The certificate shows details including the following: 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 Here’s how to apply.
2. Certificate of a pharmaceutical product (unlicensed)
Your drug must have been manufactured in the UK. You must also hold a manufacturer’s licence for the drug. Here’s how to apply.
3. Certificate of manufacturing status
The certificate confirms that named sites on a specified manufacturer licence meet good manufacturing practice requirements. Here’s how to apply.
4. Certificate of licensing status
This certificate is for importing agents who must screen bids made by an international tender for licensed or unlicensed products (excluding specials). Here’s how to apply.
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) Here’s how to apply.
You do not need to apply for all five certificates. Which one you need will depend on the importing country’s requirements. Contact your importer to find out more.
Certificate and What is covered
1. Defra-1
This certificate shows: 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 You have the option to fill in a schedule that lets you give additional specific information about your export. You can apply through email or the VMD website.
2. Defra-2
The information on this certificate shows that the export product is authorised for sale and supply in the UK. You can apply through email or the VMD website.
3. Defra-3
Same as Defra-1, but without the option to fill in additional specific information about your export. You can apply through email or the VMD website.
4. Defra-4
This certificate shows: 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. You can apply through email or the VMD website.
5. Defra-SFA
This certificate can show either: the same things as in the Defra-1 and Defra-3 certificates that your product is UK-authorised Apply for the Defra-SFA through email.
There are many licences and certificates you require when exporting pharmaceuticals overseas — and for good reason. Governments and businesses must ensure the highest standards of drug safety. Don’t make the process more difficult with complicated payment methods.
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Many countries export pharmaceuticals. After all, they are the world’s 6th most traded product (behind cars, refined petroleum, integrated circuits, vehicle parts and computers). India is the largest provider of generic drugs in the world and they exported 20% of all global drug exports. Germany was the largest exporter in the EU for 2022 (at € 68 billion). They were followed by Belgium at € 56 billion and then Ireland at € 42 billion.
The UK exports pharmaceuticals and life-saving medicines all over the world. In 2022, over £25.4 billion worth of medicinal and pharmaceutical products were exported from the UK.
Aside from exporting pharmaceuticals, the UK is a world leader in life sciences. The UK exports licensing treatments for production, converting its own IP into manufactured medicines in markets around the world, and shaping debates about the future of medicine regulations and pharmaceutical innovation.
In 2022, the UK imported £30.8 billion of medicinal and pharmaceutical products from all over the world. Their European suppliers included Belgium at £5.3 billion, closely followed by Germany.
The UK develops and manufactures a lot of pharmaceutical products too. There are around 700 businesses focused specifically on the manufacture of pharmaceutical products and preparations.
The largest companies include Cambridge-based AstraZeneca (which saw a significant boost after developing a Covid-19 vaccine) and London-based GlaxoSmithKline.
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