Guidance on the Import Certificate Scheme
Import Certificate Types
Import certificates are issued by the VMD to maintain a full audit trail of medicinal products permitted to enter the UK for veterinary use.
A suitable UK authorised veterinary (VMP) or human medicinal product may not always be available to treat a range of animals and / or diseases. The Special Import Scheme has been created to enable you to obtain medicines, which you need to treat animals under your care.
In these exceptional cases, you (the veterinary surgeon) can utilise Cascade legislation and may need to import an alternative medicine. For further information on the Cascade refer to the Cascade: Prescribing unauthorised medicines web page.
Before bringing the medicine into the UK, you should check the proposed import is available and then apply for the appropriate import certificate.
There are four types of import certificate:
Special Import Certificate (SIC) needed for a VMP authorised in another EU member state.
Special Treatment Certificate (STC) needed for a VMP authorised in a third country OR a human medicine authorised outside of the UK OR in very exceptional cases, an unauthorised medicine
Wholesale Dealers Import Certificate (WDIC) needed when a wholesaler imports and holds medicinal products that are then supplied to the holder of an SIC or STC.
Research Import Certificate (RIC) needed when a project licence holder needs a product or substance for use in research performed under a licence granted under an Animal (Scientific Procedure) Act (A(SP)A).
Who can apply
SIC or STC
You may apply for an SIC or STC 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 online.
The holder of the SIC or STC will be responsible for ensuring the conditions of the certificate are met, but they do not necessarily have to be the person administering the product, which may be done by a person acting in accordance with their instructions.
You must be the holder of a Wholesale Dealer’s Authorisation (WDA), or be a registered pharmacist to apply for a WDIC. On applying, you will need to provide your WDA or registration number.
You may only apply for an RIC if you are the project licence holder, you will need to provide your Home Office Project Licence number.
How to apply
SIC and STC
You can apply online for a SIC or STC on the VMD’s Special Imports Application page.
Some applications for SIC / STC may be applied for and fully completed online without the need for further input from the VMD; in these cases, where the VMD does not need to evaluate a clinical justification, you will be permitted to save or print the certificate upon successful completion of the online process.
If further evaluation is required, you will receive an email at the end of the online process advising you that the application is with the VMD for assessment.
Application forms are no longer available and have been removed from this guidance page. All special import applications should be submitted using the online system (SIS).
Patient Data needed
For SICs, an application can be made for a number of animals regardless of the species, because some products are authorised for use in many species and you may wish to keep these products in stock for use in multiple species on a case by case basis.
For STCs, due to a higher risk profile of the product, an application must be submitted for each individual animal. An application for a group of animals such as a herd or flock on the same treatment may be submitted as one application (CPH number needed); however, a group of horses is not regarded as a herd. Poultry cannot be used as a species type, but one application can cover either a flock of chickens or a flock of turkeys.
Justification for import needed
It is your responsibility to demonstrate that there is no suitable product authorised 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.
Product Data needed
If you are applying for a product that has not previously been permitted import into the UK in addition to a completed application you will need to provide:
- a copy of the Summary of Product Characteristics (SPC) or equivalent product information (for STC applications) in English
- copy of the product labels in the native language
This allows us to complete an import benefit:risk assessment and to correctly identify the product on the import certificate.
Further information may be requested during the assessment process.
Additional Data requirements for live vaccines
If you want to import a live vaccine you will also need to provide: * Full details of the product formulation. * Details on the origin of the strain and information on 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 details on the relationship between this and other know strains. * A risk assessment of the risk of TSEs being transmitted from any manufacturing materials of human or animal origin. * Proof of the stability of the attenuation characteristics of the seeds and data to confirm that 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
All initial STC applications for a particular animal must be evaluated. In some circumstances a ‘repeat STC’, allowing you to obtain further certificates for the same product, quantity and animal as applied for in the initial application, may be fully completed on-line. The option to apply for a repeat online and the due date will be stated on the initial certificate. A repeat may be applied for up to one week before the due date. If there is a supply problem, or known delays in receiving stock, please contact the VMD to agree a way forward.
A repeat may be applied for up to one week before the due date. If there is a supply problem, or known delays in receiving stock, please contact the VMD for resolution.
An application for WDIC can be made online.
An application for a RIC can only be made online.
Upon successful completion of the online process, you will be able to print your certificate.
The timescales start from the receipt of an application. The date of receipt is the first working day that the application is received, so those 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 (usually 14 days), the application will be refused and you will need to re-apply.
SIC and STC
|For new products||Up to 15 working days|
|For previously imported products||Up to 10 working days|
|Urgent for previously imported products||Up to 2 working days|
An application is treated as urgent if it is for a product for which the VMD thinks there is an immediate, clinically life threatening need.
However if you think your individual application is urgent, please mark it as such and provide an explanation of the urgency. We also recommend that you contact the VMD at: email@example.com.
Applications will be approved or refused within 10 working days of receipt.
A WDIC will not be issued for a new product without a SIC/STC being approved first.
A certificate is automatically issued upon successful completion of the application.
SIC and STC
No fee currently applies.
- If >100 SICs / STCs naming the wholesale dealer as the importer were issued in the 12 months prior to application, a fee of £760 applies.
The fee should not accompany the application; an invoice will be sent to you following issue of the certificate.
No fee currently applies.
Holding product in stock
Vets may hold stocks of EU authorised veterinary medicines to use as required in accordance with their import certificate conditions. Stocks of human medicines or veterinary medicines imported from third countries can only be held in stock (for use as required in exceptional circumstances) agreed by the VMD.
Validity of certificate
The certificate is valid for one year from the date of issue of the certificate.
You should only apply for a total volume that is a maximum of one years 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. There is no guarantee that a new certificate will be issued.
Due to the low risk nature of allergen products, the way in which they are authorised in other countries, and the animal welfare implications, special dispensation is allowed regarding their importation and provision.
If the product to be imported falls within the scope of the Misuse of Drugs Regulations 2001, in addition to an import certificate, you may also need additional approval documentation. Further information on import licences for controlled drugs is available from the Home Office.