Paul-Ehrlich-Institut

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

Manufacurer

Year

201420152016201720182019
Number171717171818

Number of batches produced of stock specific ITAM

Batches for animal species

Year

201420152016201720182019
Total number13.57714.13014.81913.76716.02216.681
Ruminants4.5744.0453.8703.7043.3183.606
Pig3.8754.4024.6833.9545.2105.586
Poultry including ornamental birds2.6853.1733.4643.1544.4984.126
Dog, cat, mink1.6621.8582.0582.0822.1962.477
Horse546559583702605640
Rabbit, pets / small animals1774079608279
Fish4135668779117
Zoo animals171816243450

Number of vaccines produced by specific ITAM

Vaccine doses for animal species

Year

201420152016201720182019
Total number>140 Mio.> 116 Mio.>189 Mio.>167 Mio.>176 Mio.> 218 Mio.
Ruminants>1,1 Mio.634.024677.984>1,26 Mio.>1,1 Mio.807.085
Pig>25 Mio.>21 Mio.>9,7 Mio.>7,76 Mio.>13,9 Mio.> 15,2 Mio.
Poultry including ornamental birds>110 Mio.>90,5 Mio.>138 Mio.>132,1 Mio.>145,5 Mio.> 184,3 Mio.
Dog, cat, mink287.436214.590152.427147.996136.436134.567
Horse10.7978.1986.13213.7436,9817.992
Rabbit, pets / small animals34.55211.34825.22324.74030.46026.967
Fish>3,3 Mio.>3,5 Mio.>40 Mio.>26,5 Mio.>16 Mio.> 17,6 Mio.
Zoo animals8011.4642.1231.5874.50478.692

Updated: 23.12.2020