The Paul-Ehrlich-Institut (PEI) is responsible for the approval of clinical trials (so-called field trials) of certain veterinary medicinal products that are performed outside scientific institutes or establishments in Germany.
A clinical trial is a study intended to investigate the safety and efficacy of a veterinary medicinal product under field conditions or in the context of a normal veterinary practice for the purpose of obtaining a marketing authorisation or variation of a marketing authorisation. Thus, it significantly differs from preclinical studies, which, strictly monitored, are carried out in closed animal facilities, such as the applicant’s premises or universities. Clinical trials are carried out in preparation of a marketing authorisation, during an authorisation procedure or for a variation of a marketing authorisation of veterinary medicinal products.
Clinical trials (field trials) are applied for and granted in conjunction with the provisions of Article 9 of Regulation (EU) 2019/6, Section 10 Veterinary Medicinal Products Act (Tierarzneimittelgesetz, TAMG), and in accordance with Section 11 (5) Animal Health Act (Tiergesundheitsgesetz, TierGesG).
The Paul-Ehrlich-Institut is responsible for the granting of clinical trials (field trials) for the following product groups of veterinary medicinal products:
Before a decision is made on the approval or rejection of an application, an assessment of the documents submitted by the applicant is made and an evaluation of the aspects associated with the trials, such as animal disease control. The PEI informs the competent highest state authority about the granting of clinical trials (field trials).
The planning, structure, and process of clinical trials (field trials) shall comply with the requirements of Good Clinical Practice (GCP). This is the only way to reliably use and evaluate the experimental results for national or EU-wide marketing authorisations or related follow-up procedures (such as variations).
For all batches to be used in clinical trials (field trials), the production protocol and test report must be submitted.
The Paul-Ehrlich-Institut has compiled appropriate application requirements for clinical trials (field trials) for immunological veterinary medicinal products in accordance with the TierGesG and partly with the TAMG.
Separate forms are available in German and English for the application for a clinical trial and for applications to include additional premises or batches.
For carrying out the approval procedure, fees will be charged pursuant to the Special Fees Ordinance of the Federal Ministry of Food and Agriculture for Individually Attributable Public Services in its Area of Responsibility (Besondere Gebührenverordnung BMEL - BMELBGebV).
Email: veterinaermedizin@pei.de
Updated: 26.09.2024
