Since 1 May 2014, the Paul-Ehrlich-Institut (PEI) has been responsible for the approval of field trials of immunological veterinary medicinal products outside scientific institutes in Germany. Such field trials shall be carried out in preparation for a marketing authorisation or during the authorisation procedure of those veterinary medicinal products. Thus, at least in part, they correspond to clinical trials of medicinal products for humans. With the new responsibility, an application for the appropriate permit can now be submitted to the PEI, even if the planned field trial concerns companies in more than one federal German state.
The so-called field trials with immunological veterinary drugs are clinical trials in the natural environment of the animals under controlled conditions (field conditions). Thus, they significantly differ from studies which, strictly monitored, are carried out in closed livestock facilities such as universities.
Field trials have been regulated since the entry into force of the relevant regulation of the Animal Health Act (TierGesG) on 1 May 2014 in accordance with Section 11 (5) TierGesG. Since then, the responsibility for field trials in the Federal Republic of Germany has been at the PEI.
Applications for field trials are submitted to and also granted by the PEI. The PEI informs the respective competent senior land (state) authority about granted approvals of field trials.
Before a decision is made on an approval or rejection of an application, an assessment shall be made of the animal disease control aspects of the trials and an assessment of the documents submitted by the applicant.
The planning, structure, and process of field trials should comply with the requirements of Good Clinical Practice (GCP). Evidence for this must be provided in the study protocol. This is the only way to reliably use and evaluate the experimental results obtained for national or EU-wide marketing authorisations or related follow-up procedures (such as variations).
For all batches to be used, the production and test report must be submitted.
The PEI has compiled appropriate requirements for applications for waivers for immunological veterinary medicinal products pursuant to § 11 (5) TierGesG.
This compilation is to be understood as a provisional version, since with the entry into force of the relevant regulation of the animal health law on 1 May 2014 the correspondingly amended Tierimpfstoff VO (Animal Vaccine Regulation) does not yet exist.
Separate forms are available in German and English for the application for a derogation for immunological veterinary medicinal products pursuant to § 11 (5) TierGesG and for applications for the extension of additional farms or batches.