Article 2Definitions

In addition to the definitions laid down in Articles 2 and 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council2 and Regulation (EU) 2015/2283, the following definitions shall apply:
  1. (a)

    ‘notification’ means a stand-alone dossier containing the information and the scientific data submitted in accordance with Article 14 of Regulation (EU) 2015/2283.

  2. (b)

    ‘application’ means a stand-alone dossier containing the information and the scientific data submitted in accordance with Article 16 of Regulation (EU) 2015/2283.