|
Art. 38 Additions to the documents
1 If the Notification Authority determines that the documents are obviously incomplete, it shall inform the manufacturer or only representative accordingly without delay. 2 If an assessment authority determines that the documents are incomplete or inaccurate, or that further data or tests are required for an assessment of the hazards and risks associated with the substance, it shall inform the Notification Authority accordingly. The Notification Authority shall request the manufacturer or only representative to submit additions or corrections. 3 If a robust study summary in accordance with Article 27 paragraph 2 letter b numbers 7–9 does not permit an independent assessment of a specific test, the Notification Authority may request the full study report. 4 The Notification Authority shall confirm to the manufacturer or only representative the date of receipt of additions and corrections. |