Actors
The main actors in the dossier submission process are:
Applicants
Applicants have the responsibility to provide dossiers with all relevant information on their active substances and to provide additional information if requested by the evaluating competent authority. Applicants are responsible for the quality of the data in their dossiers.
ECHA
ECHA is responsible for ensuring that the information in the dossiers is in a correct format. ECHA also makes sure that the submission process proceeds within the set timelines.
Evaluating competent authority
The evaluating competent authority is responsible for carrying out the validation of the application dossiers and subsequently for the evaluation of the dossiers submitted by the applicants. Applicants can choose which Member State they would like to have evaluating their dossiers. This is finally decided in agreement with the Member State.