# Export drugs and medicines: special rules Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/43aeb73e-75a6-47ab-b017-89630f48b0b3 Type: Detailed Guide Published: November 11, 2016 Updated: May 6, 2026 > This regulatory guidance outlines the mandatory requirements for exporting controlled drugs, human medicines, and veterinary medicines from the UK. The framework is governed by the Medicines and Healthcare products Regulatory Agency (MHRA), the Veterinary Medicines Directorate (VMD), and the Home Office. While the document does not reference a specific company inspection, it establishes the compliance standards all exporters must meet regarding Good Manufacturing Practice (GMP) and legal authorizations. Key requirements include securing specific licenses based on the substance type. Controlled drugs, such as opioids and stimulants, require a Home Office controlled drug licence. Products potentially used for lethal injections must be supported by an Export Control Joint Unit licence. For general human and veterinary medicines, companies must possess valid manufacturer, wholesale dealer, and marketing authorizations. To facilitate international trade, exporters must apply for specific export certificates. The MHRA manages five certificate types for human medicines, including Certificates of Pharmaceutical Products and Manufacturing Status. The VMD oversees the 'Defra' certificate series for animal medicines, verifying that products are UK-authorized and manufactured at sites meeting GMP standards. Required actions for companies include identifying the necessary certificate via importer consultation, submitting applications through the MHRA portal or VMD email, providing supporting evidence from marketing authorization holders, and paying the prescribed fees. Failure to adhere to these certification and licensing protocols may result in the prohibition of exports. --- ## Content You need permission to export: controlled drugs like opioids, certain stimulants or psychotropic substances certain drugs that can be used in lethal injections outside the EU medicines for humans or animals 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: medicine for humans medicine for animals 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 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: exports@mhra.gov.uk How much it costs Find out more about the fees we charge at MHRA fees 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: register to apply online by emailing exportcert@vmd.gov.uk sign in to apply for a certificate 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 exportcert@vmd.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. Select the relevant template from the document below: Export Certificate Schedule templates ( ODT , 10 KB ) 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 ## Attachments - [Certificate of licensing status application form](https://assets.publishing.service.gov.uk/media/633d2fc8d3bf7f1882807a92/Statement_of_licensing_status_of_pharmaceutical_product_s__1_.doc) - [Certificate of licensing status guidance notes](https://assets.publishing.service.gov.uk/media/5e26c732ed915d1f27a73e8a/Statement_of_licensing_status_of_pharmaceutical_products_-_guidance_notes_to_complete_application_form.doc) - [Certificate for the importation of a pharmaceutical constituent application form](https://assets.publishing.service.gov.uk/media/5e26c855ed915d1f223cdd0f/Form_-_certificate_to_export_a_pharmaceutical_constituent.doc) - [Certificate of a pharmaceutical product (licensed) guidance notes](https://assets.publishing.service.gov.uk/media/633d2f328fa8f5643908a7f2/Certiifcate_of_pharmaceutical_product_licensed_products_guidance_notes_to_complete_application_form.doc) - [Certificate of a pharmaceutical product (licensed) application form](https://assets.publishing.service.gov.uk/media/633d2f1e8fa8f56432bac969/Certiifcate_of_pharmaceutical_product_licensed_products_application_form.doc) - [Certificate of a pharmaceutical product (unlicensed) application form](https://assets.publishing.service.gov.uk/media/5ed0f5b886650c76ab17fc6c/Certiifcate_of_pharmaceutical_product_unlicensed_products_.doc) - [Certificate of a pharmaceutical product (unlicensed) guidance notes](https://assets.publishing.service.gov.uk/media/633d2f64e90e0743feb2d5c0/Certiifcate_of_pharmaceutical_product_unlicensed_products_guidance_notes_to_complete_application_form.doc) - [Certificate of manufacturing status application form](https://assets.publishing.service.gov.uk/media/633d2f738fa8f56430e70c67/Certiifcate_of_manufacturing_status_form.doc) - [Certificate of manufacturing status guidance notes](https://assets.publishing.service.gov.uk/media/633d2f9ed3bf7f187b4b3e63/Certiifcate_of_manufacturing_status_guidance_notes_to_complete_application_form.doc) - [Certificate for the importation of a pharmaceutical constituent guidance notes](https://assets.publishing.service.gov.uk/media/633d2fded3bf7f1882807a93/Export_certification_for_the_importation_of_a_pharmaceutical-constituent_-_guidance_notes_to_complete_application_form.doc) - [Export Certificate Schedule templates](https://assets.publishing.service.gov.uk/media/69f1dabfb0c3a4023e5d6df4/Export_Certificate_schedule_templates.odt)