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ITAM

Evaluation of the Notifications

Immunological veterinary medicines (ITAM) require a marketing authorisation. Excluded are inactivated immunological veterinary medicinal products produced from pathogens that are found specifically in livestock are exempted. These must be reported to the Länder authorities. The Paul-Ehrlich-Institut (PEI) has collected and evaluated these reports.

Pursuant to Section 11 (1) of the Animal Health Act (TierGesG), immunological veterinary medicinal products (ITAM) may only be marketed or used if they have been authorised by the PEI or approved by the European Commission.

This does not apply to inactivated ITAMs that have been produced using animal disease pathogens isolated on a particular animal stock in a particular animal facility and are only used in this stock. However, such so-called "subject-specific" ITAM may only be placed on the market or used if an approved or authorized immunological veterinary medicinal product is not available.

Pursuant to Section 12 (2) TierGesG, producers of stock-specific ITAM must inform the competent (state) authority about the production of this ITAM, indicating the infectious agent and the quantity produced, the number of batches produced and the size of the batches.

The competent authorities inform the PEI

  1. for which manufacturer specific ITAM a license has been granted, as well as
  2. the animal pathogen for which a manufacturing licence has been issued in accordance with point 1 and the quantity produced, the number of batches produced and the size of the batches of the ITAM specific to the stock.

The evaluations carried out so far by the PEI, based on the reports of the competent authorities, can be found in the following tables.

Evaluations

Number of manufacturers who have been granted a manufacturing license for specific ITAM

ManufacurerYear
2016201720182019202020212022
Number17171818151615

Number of batches produced of stock specific ITAM

Batches for animal speciesYear
2016201720182019202020212022
Total number14.81913.76716.02216.68114.84614.80811.433
Ruminants3.8703.7043.3183.6063.4663.3522.319
Pig4.6833.9545.2105.5865.2285.1693.926
Poultry including ornamental birds3.4643.1544.4984.1263.7433.6663.037
Dog, cat, (mink)2.0582.0822.1962.4771.5811.6001.396
Horse583702605640559616514
Rabbit, pets / small animals7960827987223110
Fish66877911711313487
Zoo animals, others16243450694844

Number of vaccines produced by specific ITAM

Vaccine doses for animal speciesYear
2016201720182019202020212022
Total number>189 Mio.>167 Mio.>176 Mio.> 218 Mio.> 202,1 Mio.> 281,7 Mio.> 220,2 Mio.
Ruminants677.984>1,26 Mio.>1,1 Mio.807.085847.904906.312747.521
Pig>9,7 Mio.>7,76 Mio.>13,9 Mio.> 15,2 Mio.> 17,0 Mio.> 15,8 Mio.> 14,7 Mio.
Poultry including ornamental birds>138 Mio.>132,1 Mio.>145,5 Mio.> 184,3 Mio.> 168,9 Mio.> 186,1 Mio.> 165,8 Mio.
Dog, cat, (mink)152.427147.996136.436134.567147.841147.841181.422
Horse6.13213.7436,9817.99210.4509.2856.109
Rabbit, pets / small animals25.22324.74030.46026.96716.77736.42127.752
Fish>40 Mio.>26,5 Mio.>16 Mio.> 17,6 Mio.> 15,0 Mio.> 78,5 Mio.> 38,4 Mio.
Zoo animals, others2.1231.5874.50478.692180.25618.709204.188

Updated: 06.02.2024