Your challenge

For existing products, product dossiers must be submitted at the latest by the date of Annex I inclusion (according to the Biocidal Products Directive) /approval (according to the Biocidal Products Regulation) of the respective active substances. Otherwise the products would lose their marketability. The exact dates by which product dossiers must be submitted are provided in the active-substance specific Inclusion Directives/Implementing Regulations.

Our solution

The first and most important steps in dossier preparation are:

  • Definition of the appropriate dossier strategy: Is the Product Family concept applicable? Should Mutual Recognition or Union Authorization be applied for? Which Members States should be approached for taking over the role of the Reference Member State?
  • Identification of data gaps and read across options between data on products of similar composition.
  • Identification of substances of concern and definition of necessary regulatory activities.
  • Performance of preliminary exposure and risk assessments (mainly for uses not covered by the active substance dossiers) to find out whether all intended uses are safe.
  • Clarification of possible critical issues with the selected Reference Member State in a pre-submission meeting.

Once the above points have been clarified, the next steps are:

  • Planning and monitoring of studies.
  • Dossier preparation, including performance of final exposure and risk assessments.
  • Dossier submission and follow-up (i.e. timely and competent response to questions raised by the authorities).

We are prepared to assist you in all above points to the extent wished by you: we can either support you on specific questions only or take over overall responsibility for the preparation of complete product dossiers.