Instructions for submission

Application

An application is made by a producer (e.g. pesticide manufacturer) for the approval of an active substance. The dossier should be presented in the format agreed by the Organisation for Economic Co-operation and Development (OECD). This is an internationally agreed format for regulatory dossier structure. This dossier structure consists of a number of documents termed as Documents A – O.

There is no specific application form. Document O could be used as a checklist to assure that a complete dossier is submitted.

Submission of dossiers

Missing and/or additional information should always be submitted in the form of an updated dossier (updated (CADDY) CD-ROM). Please note that always also updated summary documents (documents L, M, N) should be submitted (in Word format).

Ctgb’s requirements for EU regulatory submissions

   Paper dossier  Electronic dossier (CD-ROM)
RMS  0  2
Not RMS   0  1