Form “Manufacturer Information”

The basic requirement is that the manufacturer information form must reflect the information in the dossier. Problems may arise if not all the information required in the Manufacturer Information form is included in the dossier, or if more detailed information is available in the dossier. If there are more details in the dossier than are required in the Manufacturer Information form, these can be displayed in the “Flow Charts” area and then selected under the respective heading “Sub-steps according to flow chart”. If, on the other hand, the dossier contains less (detailed) information, this may be requested from the contracting party, or the corresponding section may be left blank in the manufacturer information form.