Applications concerning active substances4

1

Any person who applies for the inclusion of a new active substance in Annex I shall submit to the Ministers, the relevant competent authorities and the Commission a dossier which satisfies the requirements of Annex II, together with a dossier complying with Annex III on at least one preparation containing that active substance.

2

Where any active substance has been included in Annex I, any person may make an application for variation of the conditions subject to which the active substance was included14.

3

Any person who applies under paragraph (2) above shall submit the application to the Ministers, the relevant competent authorities and the Commission.