The application for authorisation to put alien small invertebrates into circulation, which must be submitted as part of the applicable licensing procedure in accordance with Article 26, must contain all the required information to prove that the handling of the organisms cannot contravene the requirements of Articles 15 and 16.
The application must contain the following documents, in particular:
a technical dossier with the information in accordance with Annex 3.4;
the results of previous experiments using the same organisms concerning hazards to human beings or the environment, or impairments caused to the same, in particular, experiments in contained systems or, possibly, field trials;
if available, any authorisations and evaluations from Swiss and foreign authorities for the experimental release and putting into circulation of the same organisms;
a risk determination and assessment in accordance with Annex 4;
a monitoring plan to show how the applicant will examine whether the assumptions of the risk determination and assessment in accordance with Annex 4 are correct and whether the measures to adhere to the principles of Articles 15 and 16 are sufficient, and which contains at least the following details:
the type, specificity, sensitivity and reliability of the methods,
the duration and frequency of the monitoring;
a proposal for informing the recipients (Art. 5), and for any packaging of the organisms;
The documentation of the results of previous experiments in accordance with paragraph 2 letter b may refer to data or results from another applicant, if this person has given written permission.