Technical support for applicants
Submission of a dossier
Dossiers have to be submitted in the content and format as defined in the following Guidance Documents, which can be accessed on the website of the European Commission:
- For chemical active substances:
SANCO/10181/2013– latest version - on preparing dossiers for the approval of a chemical new active substance and for the renewal of approval of a chemical active substance according to Regulation (EU) No 283/2013 (Annex Part A) and Regulation (EU) No 284/2013 - For microorganisms:
SANCO/12545/2014– latest version - on preparing dossiers for the approval or renewal of approval of a micro-organism including viruses according to Regulation (EU) No 283/2013 (Annex Part B) and Regulation (EU) No 284/2013 - For semiochemicals:
SANTE/12815/2014-latest version - Guidance Document on “Semiochemical active substances and plant protection products” - For botanical active substances:
SANCO/11470/2012- latest version, Guidance Document on "Botanical active substances used in plant protection products"
Administrative guidance:
The following practical information will assist you with the submission of a dossier
- Information on the submission of dossiers
- EU Review of active substances - Frequently asked questions of applicants
Information on fees can be found here.
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