Difference between a notification, a registration and an approval?

An application (for approval according to Section 8 Paragraph 1 Clause 2 GenTG) is (after the documents have been completed and the opinion of the ZKBS has been submitted) within a period of 90 days to decide in writing (Section 10 (5) GenTG). What is crucial for the applicant is that in the case of a permit - in contrast to the fictitious effects of a notification and application - they can only begin activities once the permit has actually been received. In this respect, it is of great interest to them how quickly they can actually expect to receive the requested permit. This period is legally defined as approximately three months. In detail, the competent authority must first confirm receipt of the application and the attached documents to the applicant without delay in writing and check whether the application and the documents are sufficient to examine the requirements for approval (Section 10 (4) and (5) Sentence 1 GenTG). What "immediately" means in this context is not regulated in more detail in the GenTG, i.e. in specialist law. In this respect, the general provisions apply, including Section 10 Sentence 2 VwVfG, which contains comparable regulations at the federal and state levels. According to this, an administrative procedure must be carried out simply, expediently, and quickly. The term "immediately" is used several times in genetic engineering law, including when referring to the obligations of operators, project managers (PL), and biological safety officers (BBS). "Immediately" means without culpable delay. Traditionally, this refers to a time frame in which a task is read, its content is understood, and then immediately implemented. Accordingly, the authority should also be required to review a notification under the Genetic Engineering Act (GenTG) within one week and check it for completeness in order to confirm receipt and completeness.

The law then stipulates that the authority has a total of 90 days (“within”) to make a final decision on an application (Section 10 (5) Sentence 1 GenTG). Even for S4 plants, this therefore implies a legal presumption that an application for approval can be processed within a standard period of 90 days. Only in exceptional cases, if a statement from the ZKBS must be awaited, is the deadline suspended (Section 10 (5) Sentence 4 GenTG) and the 90-day window can be interrupted in this respect (rule/exception principle). As soon as the missing statement from the ZKBS is received, the remainder of the 90-day period expires. The legally prescribed processing periods are also related to Section 75 Sentences 1 and 2 VwGO. According to this, an action (action for failure to act) is possible after three months from the date of application if a substantive decision on an application for an administrative act (approval) has not been made within a reasonable period of time without sufficient reason. According to established case law and literature, even in legally complex cases, sufficient reason does not exist because the authority must be able to decide difficult legal questions within a reasonable time. A continuously increasing workload of an authority, its general overload, illness, or vacation of employees are also not sufficient reasons. According to established case law and literature, such problems must be overcome through appropriate organizational measures and must not be to the detriment of the applicant (cf. VG Düsseldorf NVwZ 1994, 811). Whether such an action would actually expedite the process remains to be seen. The connection between the two provisions, however, shows that the project developer is legally entitled to a conclusive decision on his case within the time frame specified by the law. This is also essential for the applicant who wants to start constructing his facility or carrying out his further activities, but has to wait for the authority's decision in case of approval.