Clinical trial of veterinary medicinal products in accordance with Regulation (EU) 2019/6
The new EU Veterinary Medicinal Products Regulation, which entered into force on 27 Jan. 2019, is applicable from 28 Jan. 2022. According to Article 9 of this Regulation, applications for approval of clinical trials of veterinary medicinal products must be submitted to the competent authority of the Member State in which the clinical trial is to be conducted. In Austria, the BASG is the competent authority for this purpose.
Irrespective of this, the application for approval of the clinical trial must be submitted to the competent ethics committee. The Federal Ministry of Social Affairs, Health, Care and Consumer Protection is currently working on more detailed national regulations for clinical trials of veterinary medicinal products.
Definition: clinical trials of veterinary medicinal products are studies intended to investigate, under field conditions, the safety or efficacy of an investigational product/animal medicinal product under normal conditions of animal husbandry or in the context of normal veterinary practice for the purpose of obtaining a marketing authorisation or the amendment of such an authorisation.
General information on submission and implementation
Before the start of each clinical trial, an application for approval must be submitted to the BASG. The documents required for proper submission are listed in the appendix of the application form "F_Z135".
The completed application form, together with the required documentation and a general cover letter, must be submitted to the BASG via the Common European Submission Portal (CESP).
Before or at the same time as the application to the BASG, the application for approval of the clinical trial must be submitted to the responsible ethics committee (Magistratsabteilung 58 in Vienna, Animal Trials Ethics Committee for Commercial Studies).
The BASG makes a decision on the approval or rejection of a clinical trial within 60 days of receipt of a valid and complete application, taking into account the Guideline on the principles of regulatory acceptance of 3Rs (replacement, reduction, refinement) testing approaches (EMA/CHMP/CVMP/JEG-3Rs/450091/2012).
If the documents and data submitted are insufficient or do not correspond to the state of scientific knowledge and/or the clinical trial applied for is not suitable to provide evidence of the safety or efficacy of a veterinary medicinal product, the applicant is granted a period of time to remedy the deficiencies.
If the required documents are not submitted or are incomplete within this period, approval will be refused.
The electronic submission of the application, including the documents and general cover letter, is done via the Common European Submission Portal (CESP). For more information on submitting via CESP, see Electronic Submission.
Application form and Guideline for submission of clinical trials veterinary
The new fee schedule of the BASG, which came into force on 28 Jan. 2022, contains tariffs for the following services concerning the clinical testing of veterinary medicinal products:
- Clinical trials of veterinary medicinal products without determination of the waiting period
- Clinical trials of veterinary medicinal products with waiting period determination
Please refer to the BASG fee schedule (XI.8) for the current fees.