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
- for which manufacturer specific ITAM a license has been granted, as well as
- 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.
Number of manufacturers who have been granted a manufacturing license for specific ITAM
Number of batches produced of stock specific ITAM
|Batches for animal species|
|Poultry including ornamental birds||2.685||3.173||3.464||3.154||4.498||4.126|
|Dog, cat, mink||1.662||1.858||2.058||2.082||2.196||2.477|
|Rabbit, pets / small animals||177||40||79||60||82||79|
Number of vaccines produced by specific ITAM
|Vaccine doses for animal species|
|Total number||>140 Mio.||> 116 Mio.||>189 Mio.||>167 Mio.||>176 Mio.||> 218 Mio.|
|Ruminants||>1,1 Mio.||634.024||677.984||>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, mink||287.436||214.590||152.427||147.996||136.436||134.567|
|Rabbit, pets / small animals||34.552||11.348||25.223||24.740||30.460||26.967|
|Fish||>3,3 Mio.||>3,5 Mio.||>40 Mio.||>26,5 Mio.||>16 Mio.||> 17,6 Mio.|