In Germany, immunological veterinary medicinal products (IVMP) may only be placed on the market or used if they have been granted a marketing authorisation by the Paul-Ehrlich-Institut (PEI) or the European Commission. This does not apply to inactivated immunological veterinary medicinal products that are manufactured from pathogens and antigens obtained from an animal or animals in an epidemiological unit and used for the treatment of that animal or those animals in the same epidemiological unit or for the treatment of an animal or animals in a unit having a confirmed epidemiological link. An epidemiological unit means a group of animals with the same likelihood of exposure to a pathogen.
These so-called autogenous vaccines may only be placed on the market or used in exceptional circumstances and where no authorised or registered immunological veterinary medicinal product is available.
According to Article 2 (3) of Regulation (EU) 2019/6, certain rules apply for autogenous vaccines including the manufacture, veterinary prescription and prohibition of advertising.
Although inactivated immunological veterinary medicinal product shall be manufactured in accordance with the principles of good manufacturing practice according to Article 2 (3) of Regulation (EU) 2019/6, detailed guidelines on good manufacturing practice should be drawn up specifically for these products, as they are manufactured in a way that differs from industrially produced products. This ensures their quality without compromising their production and availability.
For the purpose of Section 12 (2) Animal Health Act (Tiergesundheitsgesetz, TierGesG) manufacturers of autogenous vaccines must inform the competent (state) authority about the production of this veterinary medicinal product, indicating the animal pathogens and the quantity produced, the number of batches produced and the size of the batches.
The competent authorities inform the Paul-Ehrlich-Institut about:
The Paul-Ehrlich-Institut compiles and evaluates these reports. The evaluations carried out so far by the Paul-Ehrlich can be found in the following tables.
| Manufacurer | Year | ||||||
|---|---|---|---|---|---|---|---|
| 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | |
| Number | 17 | 17 | 18 | 18 | 15 | 16 | 15 |
| Batches for animal species | Year | ||||||
|---|---|---|---|---|---|---|---|
| 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | |
| Total number | 14.819 | 13.767 | 16.022 | 16.681 | 14.846 | 14.808 | 11.433 |
| Ruminants | 3.870 | 3.704 | 3.318 | 3.606 | 3.466 | 3.352 | 2.319 |
| Pig | 4.683 | 3.954 | 5.210 | 5.586 | 5.228 | 5.169 | 3.926 |
| Poultry including ornamental birds | 3.464 | 3.154 | 4.498 | 4.126 | 3.743 | 3.666 | 3.037 |
| Dog, cat, (mink) | 2.058 | 2.082 | 2.196 | 2.477 | 1.581 | 1.600 | 1.396 |
| Horse | 583 | 702 | 605 | 640 | 559 | 616 | 514 |
| Rabbit, pets / small animals | 79 | 60 | 82 | 79 | 87 | 223 | 110 |
| Fish | 66 | 87 | 79 | 117 | 113 | 134 | 87 |
| Zoo animals, others | 16 | 24 | 34 | 50 | 69 | 48 | 44 |
| Vaccine doses for animal species | Year | ||||||
|---|---|---|---|---|---|---|---|
| 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | |
| Total number | >189 Mio. | >167 Mio. | >176 Mio. | > 218 Mio. | > 202,1 Mio. | > 281,7 Mio. | > 220,2 Mio. |
| Ruminants | 677.984 | >1,26 Mio. | >1,1 Mio. | 807.085 | 847.904 | 906.312 | 747.521 |
| 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) | 152.427 | 147.996 | 136.436 | 134.567 | 147.841 | 147.841 | 181.422 |
| Horse | 6.132 | 13.743 | 6,981 | 7.992 | 10.450 | 9.285 | 6.109 |
| Rabbit, pets / small animals | 25.223 | 24.740 | 30.460 | 26.967 | 16.777 | 36.421 | 27.752 |
| Fish | >40 Mio. | >26,5 Mio. | >16 Mio. | > 17,6 Mio. | > 15,0 Mio. | > 78,5 Mio. | > 38,4 Mio. |
| Zoo animals, others | 2.123 | 1.587 | 4.504 | 78.692 | 180.256 | 18.709 | 204.188 |
Updated: 26.09.2024
