Regulation 4 Applications concerning active substances

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.

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 included^f1.

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