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Supply Problems

To address a supply problem, under the prescribing cascade it is possible for a veterinary surgeon to use a veterinary medicine authorised in the UK for use with another animal species or for another condition in the same species. If this option is not available to the veterinarian then a human product authorised in the UK without any prior notification to the VMD may also be used. If there is no suitable UK authorised human product, veterinary surgeons may apply to import an EU authorised veterinary medicine or failing this, a veterinary medicine authorised outside the EU, once the necessary import certificate has been obtained. The veterinary surgeon may also decide to prescribe a medicine prepared extemporaneously (a "Special"). It should be noted that these options should only be explored after attempts to obtain and use UK authorised products have been unsuccessful.

The cascade is set out in Schedule 4 of the Veterinary Medicines Regulations. Guidance on the application of the cascade can be found in VMGN 13 - Guidance on the use of the Cascade (162 kb), and further information can be found on the cascade page.

For more information on the VMD's Import Certificate Schemes please see VMGN 5 - Import Certificate Schemes (133 kb), or the VMD's Special Import Site.

If you are a Marketing Authorisation Holder and wish to report a current or foreseen availability issue with any veterinary medicinal products, please complete a Reporting a Veterinary Medicinal Product UK Supply Problem form and email it to Renee Sheehan at r.sheehan@vmd.defra.gsi.gov.uk.

Viper Venom Antiserum (adder bite antivenom) for veterinary use

The VMD is aware there is no viper venom antiserum authorised in the UK for the treatment of adder bites in animals.

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

However, it has recently come to VMD’s attention that the Institute of Immunology are no longer manufacturing the antiserum. Therefore, we recommend that before submitting an application you contact the relevant manufacturer to ensure they are able to supply the quantity of product you wish to import.

The contact details of the approved manufacturers are:

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. For further information please contact Sam Ward on 01932 338496

If veterinary surgeons are aware of any other alternative products, you may submit import certificate applications for these. Each application will be assessed on its individual merits.


Edrophonium Injection BP 10mg/ml

The VMD is aware of a UK supply problem with the human authorised product Edrophonium Injection BP 10mg/ml, PL16853/0118. Edrophonium chloride is used in the veterinary industry in the diagnosis of Myaesthenia Gravis in cats and dogs. It is not known when stock levels are likely to return to normal.

To date, the VMD is not aware of any alternative veterinary products authorised in the EU; however, Enlon containing the active ingredient edrophonium chloride is authorised in USA. Applications to import this product should be made via Special Treatment Certificate (STC) using the VMD Special imports online application system, available at: https://www.vmd.defra.gov.uk/sis/default.aspx.

If veterinary surgeons are aware of any other alternative products, you may submit import certificate applications for these. Each application will be assessed on its individual merits.

If you would like further information on Edrophonium Injection BP 10mg/ml, please contact Alliance Pharmaceuticals Limited on 01249 466966.


Bovilis Ringvac

The VMD is aware of a UK supply problem with Bovilis Ringvac (Vm01546/2009), which is indicated for the active immunisation of cattle to reduce clinical signs of ringworm caused by Trichophyton verrucosum and to shorten the recovery time of infected cattle showing clinical signs of ringworm - due back in stock end of June 2014.

To date, the VMD is aware of one alternative veterinary product authorised in the EU; Trichoben containing the active ingredient Trichophyton verrucosum which is authorised in the Czech Republic.

Veterinary surgeon application(s) to import this product or any other alternative products from outside the UK should be submitted via the VMD Special imports online application system, available at: https://www.vmd.defra.gov.uk/sis/default.aspx.

Each application will be assessed on its individual merits.

If you would like further information on Bovilis Ringvac, please contact MSD Animal Health on 01908 685 685.


ACP Injectable Products

The VMD has been advised ACP Injection 2mg/ml (solution for injection), Vm12501/4124, which is indicated for anaesthetic premedication, tranquilisation and sedation in cats and dogs is now fully available in the UK. Applications to import alternative products are no longer being accepted.

The VMD is aware of an ongoing supply problem with ACP Injection 10mg/ml (solution for injection), Vm12501/4125, which is indicated for anaesthetic premedication, tranquilisation and sedation in horses. It is not known when stocks will become available.

The VMD is aware of two EU alternatives containing the active ingredient Acepromazine Maleate:

  1. a) Calmivet Solution for Injection (5mg/ml), which is authorised in France. Applications to import this product for use in horses only are currently being accepted.
  2. b) Vetranquil 1% Solution for Injection (10mg/ml), which is authorised in Germany and the Netherlands. Applications to import this product for use in horses only are currently being accepted.

We will also consider permitting the import of the above alternative products for other heavy livestock where sound arguments are presented.

Applications to import these products should be made via Special Import Certificate (SIC) using the VMD Special imports online application system, available at: https://www.vmd.defra.gov.uk/sis/default.aspx.

If veterinary surgeons are aware of any other alternative veterinary products authorised in an EU country, you may submit an import certificate applications for these. Each application will be assessed on its individual merits.

If you would like further information or clarification please contact Novartis Animal Health UK on 01276 694402.


Equip EHV1,4

The VMD is aware of a UK supply problem with Equip EHV1,4 Vm 00057/4316, which is indicated for the active immunisation of horses to reduce clinical signs due to infection with Equine Herpesvirus 1 and 4 and to reduce abortion caused by EHV-1 infection.

In light of this availability issue, the VMD has been permitting the import of a known alternative authorised product from Spain; Pneumabort K+1B, which is indicated for the active immunisation of horses against respiratory disease caused by equine rhinopneumonitis herpesviruses EHV type 1p and EHV type 1b, and to prevent abortions induced by EHV type 1 in pregnant mares. However, the authorisation for this alternative product has now expired and the VMD anticipate availability issues with this alternative product in the near future.

If veterinary surgeons are aware of any other alternative products, you may submit import certificate applications for these. Each application will be assessed on its individual merits.

If you would like further information on Equip EHV1,4 please contact Zoetis UK Limited on 01737 332828


Synacthen

The VMD is aware of a European supply problem with the human authorised product Synacthen, PL16853/0017. Synacthen is a synthetic ACTH, indicated as a diagnostic test for the investigation of adrenocortical insufficiency. It is used for the diagnosis of hyperadrenocorticism (Cushings), hypoadrenocorticism (Addison’s) and for monitoring trilostane therapy in cats and dogs. Normal stock levels are due to return to market from the middle of October 2013 but priority will be given to human supply.

If veterinary surgeons are aware of any other alternative products, you may submit import certificate applications for these. Each application will be assessed on its individual merits.

If you would like further information on Synacthen, please contact Alliance Pharmaceuticals Limited on 01249 466966.

For further veterinary advice on how to monitor dogs treated with trilostane in the absence of synthetic ACTH, please contact Dechra Veterinary Products on 01939 211200.


Navilox 3% w/w Powder for In-Feed Use

The VMD has been made aware of a supply problem with Navilox 3% w/w Powder for In-Feed Use, Vm08007/4026, which is indicated for treatment of Navicular disease in horses. It is not currently known when stocks will be available.

To date, the VMD is not aware of any alternative veterinary products authorised in the EU; however, Circulon Oralject Paste containing the active ingredient Isoxsuprine Hydrochloride is authorised in Australia. Applications to import this product should be made via Special Treatment Certificate (STC) using the VMD Special imports online application system, available at: https://www.vmd.defra.gov.uk/sis/default.aspx.

If veterinary surgeons are aware of any other alternative products, you may submit import certificate applications for these. Each application will be assessed on its individual merits.

If you would like further information or clarification please contact Vetoquinol UK Limited, on 01280 814500.




Last Updated: 11 March 2013

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