Safety control of veterinary vaccines reduces risks of animal diseases


<p>Controlled veterinary vaccines decrease the risk of spread of animal diseases both nationally and cross-borders. The Finnish Food Safety Authority Evira is the Official Medicines Control Laboratory (OMCL) of veterinary vaccines in Finland. Finland is a member of a network of EU countries where each vaccine batch is certified only by one medicines control laboratory. This mutual recognition reduces the amount of work for medicines control laboratories and facilitates the release of vaccines on the market. Batch control of vaccines ensures that veterinary vaccines imported to Finland comply with the specifications of the marketing authorisation.</p>

The official medicines control laboratory in an EU country inspects the production and testing documentation of the manufacturer of the veterinary vaccine and certifies the vaccine before it is released on the market.

Evira tests a part of the vaccine batches in the marketplace every year. In addition, a vaccine can be tested by using various tests whenever there is suspicion that a vaccine has caused adverse reactions for an animal or when the efficacy of the vaccine has not been as expected.

Evira does not test all batches but focuses on vaccines that are deemed to constitute the greatest threat to the status of animal diseases in Finland. For example, Finland is free of Newcastle disease in poultry, so live poultry vaccines are tested for the presence of this virus. Any spreading of the virus vaccine to poultry could jeopardise freedom from disease and incur significant costs.

Few veterinary vaccines for sale in Finland
Products with marketing authorisation are not available for the prevention of all diseases. Instead, the Finnish Medicines Agency Fimea grants products special permits or fixed-term licences. These products are released by national decisions to the Finnish market only. National release is also used when a vaccine is needed for use urgently and there is no product in Finlandagainst the disease. In all, 37 batches were released nationally in 2012. The number of national releases has decreased substantially in the past few years as collaboration within the OMCL network has been enhanced.

Evira releases annually slightly fewer than 300 batches of vaccines in Finland. That number has remained unchanged in recent years. In 2012 Evira recognised 168 batches of vaccines for which another OMCL had inspected the testing documentation. Evira certified 78 batches. The number of batches annually certified by Evira has ranged between 75 and 99.

Additional information:
Professor Liisa Kaartinen, Head of Unit , Veterinary Virology Research Unit
tel. +358 40 840 7364, liisa.kaartinen at-merkki-kapea.gif : 0 kB

Karoliina Alm-Packalén, Senior Researcher, Veterinary Virology Research Unit
tel. +358 40 486 0052, karoliina.alm-packalen at-merkki-kapea.gif : 0 kB

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