Apply for an import certificate to import a medicinal product into the UK for veterinary use.
A suitable UK authorised veterinary (VMP) or UK authorised human medicinal product may not always be available to treat a range of animals or diseases. In such scenarios, you can apply to the Veterinary Medicines Directorate (VMD) for an import certificate to bring a medicinal product into the UK for veterinary use using Cascade legislation.
You must be in receipt of an import certificate before bringing the medicine in to the UK. You should also check the proposed imported product is available.
Import certificate types
There are 3 types of import certificate:
- Special Import Certificate (SIC) - for a medicinal product imported from outside the UK
- Wholesale Dealers Import Certificate (WDIC) - for medicinal products imported and held by a wholesaler to supply SIC holders
- Research Import Certificate (RIC) - for a product or substance for research licensed under the Animal (Scientific Procedure) Act
Who can apply
A Special Import Certificate (SIC) is needed when a veterinary surgeon imports, uses or holds any medicinal product from outside the UK for veterinary use.
The holder of the SIC will be fully responsible for ensuring the conditions of the certificate are met. Administration of the product may be done by a person acting in accordance with their instructions.
A Wholesale Dealer Import Certificate (WDIC) is needed when a wholesale dealer imports and holds medicinal products that are then supplied to the holder of an appropriate import certificate.
A Research Import Certificate (RIC) is needed when a Home Office project license holder needs a medicinal product for use in animal research used in accordance with a license granted under an Animal (Scientific Procedure) Act (A(SP)A).
How to apply
Apply for a SIC using the VMD’s online Special Imports Scheme Application
You may apply for a SIC if you are a veterinary surgeon registered with the Royal College of Veterinary Surgeons (RCVS). You will need to enter your RCVS membership number when applying for a certificate.
a) Products that appear in the online drop down
Products for which VMD are currently issuing import certificates for will appear in a drop down menu on the online application page. In order to complete an application for one of these products, please follow the on screen instructions.
b) Products that do not appear in the online drop down
Products that require full assessment will not appear in the online drop down, for example new proposed import products. The VMD conducts an import benefit:risk assessment. The data required to complete this analysis will vary on a case-by-case basis.
Justification for import
It is your responsibility to demonstrate that there is no suitable UK authorised veterinary product available to justify your intended use of the Cascade. Factors such as the cost of the products and the withdrawal period are not acceptable reasons to import alternatives.
To help you with this, a list of all authorised veterinary medicines in the UK is available on the Product Information Database.
If a UK authorised product is unavailable due to a temporary supply issue, the VMD will only consider the importation of an alternative when no other suitable alternative UK product exists and will only permit import until the supply issue is resolved or another suitable product becomes available on the UK market. In such scenarios you should consider the likely quantities needed and purchase appropriately.
Data you need to provide
For products that have not previously been permitted into the UK you must provide:
- a completed online application form
- a copy of the Summary of Product Characteristics (SPC) or equivalent product information in English
- copy of the product labels in the native language
This allows the VMD to do an import benefit-risk assessment and to correctly identify the product on the import certificate.
Extra data for live vaccines
To import a live vaccine, you also need to provide:
- full details of the product formulation
- details of the origin of the strain and whether the strain is considered exotic to the UK. If the strain is not considered exotic to the UK, provide evidence to confirm this
- information on the genotype of the strain and the relationship between this and other known strains
- a risk assessment of Transmissible Spongiform Encephalopathies (TSE) being transmitted from any manufacturing materials of human or animal origin
- proof of the stability of the attenuation characteristics of the seeds and data confirming there is no risk of reversion to virulence for the vaccine strains
- details of any extraneous agents testing performed on the product
- a batch release protocol for a recent batch detailing all the tests conducted on the finished product together with the results of these tests
An import certificate will be available immediately upon successful completion of your application. You can choose to print this and it will also be automatically emailed to you.
Certificate following assessment
Following assessment, a product may be considered to have a higher import risk profile. This means a certificate will be emailed to you but restricted to use in a named individual animal or herd/flock. For this purpose, horses cannot be considered as a group animal.
During assessment, you may be asked to provide additional product or patient data in support of your application.
The VMD will contact you if further information is required using the contact details you have provided. In exceptional cases, the VMD may permit product to be held in stock for emergency use.
If your application is unsuccessful, a letter describing the reason why will be emailed to you.
Validity of Certificate
Import certificates are valid for one year from date of issue. You should only apply to import a volume that meets your immediate clinical need and only up to a maximum of one year’s supply.
If you have product remaining when your certificate expires, you must re-apply for a new certificate to continue to hold and use that product.
If the product to be imported falls within the scope of the Misuse of Drugs Regulations 2001, you may also need additional approval documentation. Further information on import licences for controlled drugs is available from the Home Office.
Apply for a WDIC using the VMD’s online Special Imports Scheme Application
You must be the holder of a Wholesale Dealer’s Authorisation (WDA) with the appropriate permissions or be a registered pharmacist to apply for a WDIC. On applying, you will need to provide your WDA or registration number.
Applications will be considered if a valid SIC has been issued, otherwise your application will remain on hold for a maximum 14 days awaiting a SIC approval.
Products for which the VMD are currently issuing SICs for will appear in a drop-down menu on the online application page. In order to complete a WDIC application for one of these products, please follow the on-screen instructions.
If a UK authorised product is unavailable due to a temporary supply issue, the VMD will only consider the importation of an alternative when no other suitable alternative UK product exists. We will only permit import until the supply issue is resolved or another suitable product becomes available on the UK market.
In such scenarios you should consider the likely quantities needed and purchase stock appropriately.
Apply for a RIC using the VMD’s online Special Imports Scheme Application
You may only apply for a RIC if you are the project licence holder, you will need to provide your Home Office Project Licence number.
The timescales start from the receipt of a valid application. Applications submitted at a weekend, or on a bank holiday, will be classed as received on the first working day thereafter.
If any information is missing, or further clarification is required, the VMD will contact you to request this. The timescales will be suspended pending a response from you. If a response is not received within the specified deadline the application will be refused and you will need to re-apply.
|Previously imported SIC products||Instantly available or up to 10 working days if further assessment is required|
|New SIC products (including applications for emergency stock use and new species)||Up to 15 working days|
Where there is an immediate, clinically life-threatening need, email the VMD at firstname.lastname@example.org,mark it as urgent and provide an explanation.
There are no fees for online applications
If at least 100 SICs naming the wholesale dealer as the importer were issued in the last 12 months, the fee is £760. You’ll be sent an invoice following issue of the certificate.
Report a supply problem
You can report a known or foreseen supply problem on our Report a supply problem page