GovWire

Guidance: Known supply problems with animal medicines

Veterinary Medicines Directorate

April 13
14:32 2023

Companies are encouraged to report supply problems to the Veterinary Medicines Directorate.

Where a supply problem exists and there is no alternative product, vets may prescribe using the cascade. Vets are reminded that it is their responsibility to apply use of the Cascade appropriately based on clinical need

More information can be found on The Cascade: Prescribing unauthorised medicines page.

For non-UK products vets must apply for a certificate to import a Veterinary Medicine into the UK.

For information on manufacturers of extemporaneous products, please read the ManSA Register

Supply problems exist with the following products

Veterinary replacement fluids for infusion

The VMD is aware of a shortage of veterinary replacement fluids for infusion.

We understand that whilst some UK authorised veterinary fluids remain available, these are in limited quantities.For details of the supply situation for individual UK authorised products, please contact the relevant Marketing Authorisation Holder or your usual wholesaler.

While there are supply issues with some replacement fluids, vets may consider use of alternative products under the Cascade, however vets should make every effort to first obtain a UK authorised product.

Due to the clinical need for this category of product, the VMD has recently assessed the following products for import under the Special Import Scheme:

Product Country of Origin MA Numbers
Ringer lattato soluzione per infusione endovenosa per tutte le specie Italy 102322029, 102322043, 102322068, 102322031, 102322070, 102322056, 102322082, 102322094, 102322118, 102322120, 102322132, 102322144, 102322157
Vetivex solution au ringer lactate pour perfusion pour bovins chevaux chiens et chats France FR/1/2198629 1/2013

To address the shortage, veterinary surgeons may consider use of the above products under the cascade once the necessary import certificate has been obtained. If veterinary surgeons are aware of any other alternative products, they can submit an SIC application for these.

As a reminder, where authorised products are temporarily unavailable vets should consider the likely quantities needed and purchase appropriately.As soon as an authorised product is available again, vets are expected to use this even if they still have stocks of unauthorised products.

Vaccines for immunisation against equine influenza and tetanus

The VMD have been informed that there is now returned supply of UK authorised equine flu and tetanus vaccines.

The VMD will no longer accept applications to import alternative products, including Vetera 2XP licensed in the USA.

Vaccine for immunisation against ringworm

The VMD is aware of a supply problem for Bovilis Ringvac (MSD Animal Health UK Ltd), indicated for the active immunisation of cattle to reduce clinical signs of ringworm caused by Trichophyton verrucosum.

Due to the clinical need for a vaccine of this indication in the UK, the VMD has approved Trichoben for import. Trichoben is authorised in both the Czech Republic and Netherlands as per the following

Product: Trichoben
Country of Origin: Czech Republic
MA number: 97/200/92-C
Product: Trichoben
Country of Origin: Netherlands
MA Number: REG NL 121040
Distributor Contact Details Animal Health Distributors. email: SDMHOUSE@blueyonder.co.uk or tfleming@cahg.ie telephone: 07804 601851 or +353 87 230 2034

To address the supply problem, veterinary surgeons may consider use of the above products under the cascade once the necessary import certificate has been obtained. If veterinary surgeons are aware of any other alternative vaccines, they can submit an SIC application for these vaccines. Each application will be assessed on its individual merits.

In advance of applying for SICs for any product it is recommended that the supplier is contacted to ensure that sufficient stock is available to meet your needs.

More information can be found on the VMDs Special Import Scheme guidance page.

Products containing acepromazine for anaesthetic premedication, tranquilisation and sedation in horses

Following the granting of a marketing authorisation the VMD have been informed that there is availability of a 10mg/ml acepromazine solution for injection:

  • AceSedate 10mg/ml solution for injection for horses Vm: 25296/4008

Therefore the VMD will no longer issue import certificates for alternative acepromazine products, including:

  • Calmivet solution for injection (5mg/ml), licensed in France
  • Vetranquiol 1% solution for injection (10mg/ml), licensed in Germany and Netherlands

This will take effect immediately.

Existing certificates will remain valid until their date of expiry, however veterinary surgeons are reminded to apply the Cascade responsibly and use UK authorised product where available.

2mg/ml presentations are also available. Information on authorised acepromazine-containing products is available on the VMDs Product Information Database.

Viper Venom Antiserum for veterinary use (adder bite antivenom)

There is no viper venom antiserum licensed in the UK for the treatment of adder bites in animals.

VMD accept applications to import European Viper Antiserum from Biomed (Poland) and Institute of Immunology, Zagreb (Croatia).

Before submitting an application contact the relevant manufacturer to ensure they are able to supply the quantity of product you wish to import.

Contact details of the approved manufacturers

BIOMED Warsaw
Wytwornia Surowic i szczepionek BIOMED Ltd
Ul. Chelmska 30/34
00-725 Warsaw
Phone. 022 841 4071

Institute of Immunology
Rockefellerova 2
10000 Zagreb, Croatia
Phone +385 1 46 84 500

In urgent cases the antivenom may be supplied, purchased and used prior to the special treatment certificate being obtained from the VMD. This is a special dispensation made for this clinical condition only.

Published 30 September 2014
Last updated 13 April 2023 +show all updates
  1. Information updated concerning availability of equine influenza and tetanus vaccines.

  2. Information updated concerning availability of equine influenza and tetanus vaccines.

Related Articles

Comments

  1. We don't have any comments for this article yet. Why not join in and start a discussion.

Write a Comment

Your name:
Your email:
Comments:

Post my comment

Recent Comments

Follow Us on Twitter

Share This


Enjoyed this? Why not share it with others if you've found it useful by using one of the tools below: