The required data in order to assess an application in accordance with Regulation (EC) No. 1107/2009 are laid down in law. The current data requirements (or technical requirements) are set out in Regulation (EU) No. 283/2013 for the active substance and in Regulation (EU) No. 284/2013 for the product (formulation).
In addition, there are also national requirements which are specific to each Member State.
The technical requirements are divided into various areas of expertise:
The data provided is proposed in a draft Registration Report (dRR). This is a summary of the assessment and the results based on the data. The dRR also contains a proposal for the labelling of the product. You can find more information regarding the dRR in our guide.
You can find detailed information regarding the administrative requirements in our guide.