Friday, October 11, 2019

From 7 October there will be only one type of certificate, the new Special Import Certificate (SIC), issued to veterinary surgeons wishing to import a medicine for veterinary use. The VMD will no longer issue Special Treatment Certificates (STC).

Applying for a certificate will continue to be a simple, online application process. The application form will give one option; ‘I am a Veterinary Surgeon and wish to import a product from outside the UK’.

An SIC will be issued for:

  • a veterinary medicine authorised outside the UK
  • a human medicine authorised outside the UK
  • in very exceptional cases, an unauthorised medicine

An SIC will be issued for either a specified number of animals or for a named animal or herd for products considered by the VMD to have a higher risk profile. The VMD will define products with a higher risk profile based on an initial assessment of the product and available literature.

Assessment

For a product that the VMD has not assessed before, and therefore is not visible in the dropdown menu of products, you must continue to submit a minimum data package with your application, consisting of:

  • a copy of the Summary of Product Characteristics (SPC) or equivalent product information in English
  • a copy of the product labels in the native language

You must also provide sound justification indicating why there is no suitable UK authorised veterinary product you can use. Factors such as the cheaper cost of the products and preferred withdrawal periods are not acceptable reasons to import medicines.

During assessment, you may be contacted by a VMD scientific assessor to seek further data about the product you wish to import or clarification on how it will be used and why. This may include, but is not limited to, the following:

  • Animal safety data
  • Full details of the product ingredients
  • Manufacturing/production information, such as Batch release protocol
  • Quality assurance information, such as tests of live vaccines for viral contamination (extraneous agents)

If during assessment, we consider the product to be a higher risk import you will be required to provide the following details:

  • Name of individual animal or herd CPH number
  • Number of animals, if it is a herd/flock of animals (a group of horses is not accepted as a herd)
  • Animal/herd owner’s surname
  • Animal/herd owner’s address, including post code

Registration

You must register to use the online application system on GOV.UK if you have not used it before. A Video tutorial on how to register and apply for an SIC will be available soon on YouTube.

Existing import certificates

All existing import certificates, including STCs, will continue to remain valid for up to one year from the date of issue. If your application for an STC is undergoing assessment on the 7 October 2019 the VMD will continue to assess your application to our published timescales. If your application is approved you will receive an SIC, if not, a refusal letter.

If you have any questions, please email: importcert@vmd.gov.uk

Futher information


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