BVL evaluates the study protocols for clinical trials and residue depletion studies based on data provided by the applicant and based on further scientific data. For studies in food-producing animals, applicants may apply for withdrawal periods according to §10 TAMG allowing for the animals and/or foodstuffs derived thereof to enter the food chain.

Documents required for application

An application for the approval of clinical trials including residue depletion studies and, if applicable, for setting withdrawal periods according to §10 TAMG needs to include the following documents and information:

• Cover letter
• Fully completed application form (only available in German).
• German Summary of product characteristics (latest version), if the test product is already authorised as a veterinary medicinal product in the EU/EEA and if no manufacturing processes other than labelling are undertaken. Otherwise, the information listed below (link Annex 1) need to be submitted.
• In case of positive controlled studies, the summary of product characteristics of the comparator product needs to be provided in German.
• Declaration of consent of the animal owner or representative - to be provided in German, see Annex 5.

Additional requirements for the approval of clinical trials:

• Investigator's brochure: compilations of the main preclinical data (pharmacology, toxicology, information on user safety as well as special precautions for users including animal owners and persons living in the same household, target animal tolerance, dose justification) preferably in tabular form including a short summary (30 pages should not be exceeded) and of the main clinical data (study protocol, proof of qualification of the study director, relevant data from previous studies, if applicable). The preclinical data may be provided as part of an expert report. Original data do not need to be submitted, but should be available and submitted on request. The study protocol incl. a protocol for statistical analysis should be completed and submitted according to Annex 2.

Additional requirements for the approval of residue depletion studies:

• Information and justification on the purpose, suitability and necessity of the study
• Summary of results of the pharmacological-toxicological studies and information on user safety (precautions for the person administering the test product to the animals) and safety for the target animal. This information may be provided as part of an expert report. Original data do not need to be provided, but should be available and submitted on request.
• Study protocol including information according to Annex 3
• Proof of qualification of the study director

Additional requirement for setting withdrawal periods according to § 10 TAMG:

• Proposal for suitable withdrawal periods including scientific justification according to Annex 4

If the application is valid and positively evaluated, the approval is granted within 60 days.

Invalid applications

Applications are considered invalid, if

• the documents and data submitted are insufficient or do not correspond to the state of scientific knowledge,
• the clinical trial is not suitable to demonstrate the safety or efficacy of a veterinary medicinal product,
• the residue depletion study applied for is not suitable for achieving the intended regulatory purpose of the study.

Applicants are requested to address any shortcomings in their applications within 90 days. If shortcomings remain after this period, the application is refused.

The approval is also refused if there is evidence that test facilities are not qualified for conducting clinical trials or residue studies.

For withdrawal periods, assumption of approval according to sentence 1 §10 (7) TAMG does not apply. Food-producing animals or foodstuffs derived from these animals may only enter the food chain if corresponding withdrawal periods have been set by the BVL.

Records of the clinical trials conducted must be kept and shall be submitted on request. After completion of the residue depletion studies, results on residues of the veterinary medicinal products or their metabolites in foodstuffs (including information on the analytical methods used) shall be submitted to the BVL without request.

For the approval of clinical trials and residue depletions studies as well as for setting withdrawal periods according to §10 TAMG costs are charged in accordance with the Special Fees Regulation of the Federal Ministry of Food and Agriculture (BMEL, only in German).

The application shall be submitted electronically via the Common European Submission Portal (CESP). See Annex 6 for details of the CESP submission. The application should preferably be provided in German; however, unless otherwise specified above documents in English are acceptable.

Assessment reports and decisions of the BVL will be issued in German only.

Contact: TAM-Pruefungen@bvl.bund.de