SOFOS 360
Permit
All activities with genetically modified organisms (GMOs) within contained use must be notified or a permit must be applied for. To determine whether you must make a notification or apply for a permit, you first carry out a risk assessment for your activities with GMOs. The outcome of the risicobeoordeling determines the containment level and therefore the application procedure. A notification procedure applies to levels I and II-k and a permit requirement applies to levels II-v, III and IV. For work at schools (S-I), another rule applied. In addition, different rules apply for downscaling, doubt and deviation from appendix 5 (2.8 procedure), applying for admission to appendix 2, 4, 7 or 11 (2.13 (a) procedure), procedures for large-scale work (MI-I, MI -II and MI-III) and requesting deviating work and design regulations (ATV procedure). For the current description of the procedures, see Procedure description 'Request for permit or submit notification (RIVM)' ">risicobeoordeling
With the help of this screen you can create a new permit or edit an existing permit.
The file number of a permit generally has a fixed form:
The naming system for IG files is as follows: procedure code / last 2 digits of a year / serial number within the year consisting of 3 digits / containment level / consecutive number (e.g. IG 17-456_IIk-003). The naming system for market files (submitted under 2001/18 / EC) is as follows: procedure code / abbreviation of the Member State where the application was submitted / last 2 digits of a year / serial number within the 2-year year (eg C / NL / 17/01).
You can use the following abbreviations for the procedure:
Examples: IG 14-014-000, IG 14-014-001, IM-MV 16-007_000
The file number is only empty if you do not know it yet (it will only become known when the application has been submitted to RIVM and you have received a confirmation letter). If the file number is known, you must enter it.
You also indicate which procedure is involved, whereby you in fact also record part of the file number. In addition, you state the intended start and end date of the permit or notification. You also indicate the type of application. This type is again dependent on the risicobeoordeling.
Next you indicate which activity you want to do within the permit application. You also indicate which employees play a role within the project. You must specify at least one biological safety officer. The employees with the most important roles are shown in the fields on the main screen.
Finally, you can include various comments regarding the request or notification and you can link documents to the request or notification.