Export certificates for veterinary medicines
How to legally export veterinary medicinal products (VMPs) from the UK.
You must make sure that the product to be exported can be legally supplied and used in the country you’re exporting it to.
To be able to export products of any legal category, other than AVM-GSL, you must be authorised to be in possession of the product in the UK, ie:
- the holder of a marketing authorisation (MAH)
- a manufacturer that holds an authorisation (ManA) relevant to the product to be exported
- the holder of a wholesale dealer’s authorisation (WDA)
Types of certificate
You must apply for the type of certificate that meets your needs.
Certifies that the product to be exported is subject of a valid marketing authorisation (MA) in the UK, ie authorised for sale and supply in the UK.
Defra-1 and Defra-3
Certifies that the manufacturing site is in the UK and is GMP (Good Manufacturing Practice) compliant (Inspected by the Medicines and Healthcare products regulatory Agency (MHRA) or VMD). The certificate will include the UK administrative address and UK manufacturing site address(es) and the authorised operations at the site.
No schedule is required for a Defra-3.
Certifies that the:
- active substance(s) in the product to be exported is available in a UK authorised product
- exported product is manufactured in the UK by an authorised GMP compliant manufacturer
The certificate will include the UK administrative address and UK manufacturing site address(es) and the authorised operations at the site.
Defra-SFA (Specified Feed Additive)
Certifies one of the following:
- the manufacturing site is in the UK and is GMP compliant - if so the certificate will include the UK administrative address and UK manufacturing site address(es) and the authorised operations at the site
- the SFA is an authorised product
Content of certificates
The VMD can only approve details on certificates that can be found in either or both the UK ManA and MA.
Some countries need information that the VMD cannot verify. You can include extra information with your applications for Defra-1, 2, or 4 certificates.
The extra information must include the following standard wording, which the VMD will sign and date on issue:
Defra-1 and 4 wording
The VMD stamp and signature on this page confirm 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.
The VMD stamp and signature on this page confirm the veterinary medicines named on page two hold a Marketing Authorisation in the same name. It does not independently verify any of the other information contained on this page.
How to apply
You need a password to apply online - email firstname.lastname@example.org.
You can’t apply online for a Defra-SFA certificate.
Postal applications are no longer accepted.
All schedule templates referred to are also available online for you to download and use:
Defra-1 schedule template (MS Word Document, 19KB)
Defra-2 schedule template (MS Word Document, 18.5KB)
Defra-4 schedule template (MS Word Document, 18.3KB)
Defra-SFA schedule template (MS Word Document, 16.5KB)
The application and all supporting documentation must be in English.
Applications by email must include a covering letter on headed paper.
A valid email address for the invoice must be submitted and failure to do so will result in your application being rejected.
All applications, excluding those for Defra-3, must include a schedule; a document listing specific information about the proposed exporting activity.
Defra-2 certificates must include the name of the UK authorised product on the schedule. You may also include the name of the product in the importing country.
If you are not the manufacturer of the product to be exported, you must provide a letter of access from the manufacturer giving the VMD permission to use their details and authorisation number. This is only applicable if you are applying for a Defra-1, 3 or 4 certificates.
If required by the third country, you may include a statement in the schedule that the product is free from ingredients of a ruminant origin. You must make it clear that the statement is made by you and not by the VMD or Defra.
You may also request the following documents with your application, which we will attach to your export documentation once issued:
- Manufacturing Authorisation(s), which provides proof of manufacturing activities, which are authorised by the MHRA or VMD
- Summary of Product Characteristics (SPC) and / or product literature
- Marketing Authorisation certificate as issued by the VMD
If you want to submit Spanish or French versions of the documents, we’ll attach them to the export documentation. However, the VMD will include a statement on the certificate that we cannot verify the authenticity of these documents. You must make sure the documents are true and correct.
The VMD will either issue the export certificate or tell you why it hasn’t been issued within 10 days of receiving your complete application.
If any information is missing from your application, you’ll be asked to submit a new application. You will not be charged for the invalid application.
An export certificate may not be issued for reasons including:
the application is incomplete or, in the VMD’s view, contains false, misleading or unsubstantiated information.
the application contains information that the VMD cannot verify and is not required as part of the application for example:
- details of products that are not manufactured by a registered GMP UK manufacturer
- details of medical devices
- names the UK as country of import
- does not include the name of the country of import
- the schedule provided does not match the VMD template
The fee for an application for an export certificate is £30, and £15 for each certified copy.
The VMD will invoice you electronically after completion of the application process.