The lovely documents – what does § 17 GenTG actually regulate?

The regulation largely refers to documents that require animal testing. Only Section 17 (1) Sentences 1 and 2 of the GenTG also cover the documents that must be submitted in normal approval procedures. Section 17 (1) Sentence 1 of the GenTG stipulates that documents are not required in the approval procedure if the competent authority has sufficient knowledge . This probably applies, on the one hand, to knowledge that is publicly available, such as statements from the ZKBS or the ABAS. In individual cases, the question of whether the authority has sufficient knowledge with regard to certain documents can be clarified with the authority in advance. The first half of Section 17 (1) Sentence 1 of the GenTG then specifies that the operator can also refer to documents that he or a third party has submitted in a previous procedure . The intention is that the same documents do not have to be submitted again and again if the operator has already submitted corresponding documents in a previous procedure. As far as his own documents are concerned, he can refer to a file number belonging to his work or his facility if he has submitted the documents under this file number. The further sentences of the regulation then refer to the circumstance that the operator has received/requires confidential documents from a third party and this third party has not given consent to the use of the documents. Dependence on third-party documents is particularly common in the area of ​​research at universities and companies, for example in clinical studies. The use of such documents by the operator or by the authority by way of official investigation requires the consent of the third party in any case (Section 17 (1) Sentence 4 GenTG). Ultimately, with regard to the question of the use of third-party documents, a claim to remuneration is also provided for under the aspect of the use of saved expenses (Section 17 (3 GenTG)) and it is regulated how to deal with a majority of applicants who are jointly dependent on third-party documents (Section 17 (4 GenTG). In practice, Section 17 (1) (2) GenTG is generally relevant, according to which documents do not have to be submitted multiple times. This certainly does not include application forms AZ S1 and A, which must be used to apply for notifications, registrations, or approvals. However, it is conceivable that the discount could be used for things like site plans of laboratories, identical equipment, and also for individual forms from previous work if nothing has changed, such as form sheet M, but possibly also forms GS, GE, or GV if these have already been submitted for another genetic engineering work and nothing has changed with regard to the individual details.