I.C.3. Data protection in the EU

All legal requirements of the IR, including those relating to the record management described in I.B.10., shall apply without prejudice to the obligations of national competent authorities and marketing authorisation holders relating to their processing of personal data under Directive 95/46/EC or the obligations of the Agency relating to its processing of personal data under Regulation (EC) No 45/2001 [IR Art 39].