ECPA publishes Technical Guidance papers for the implementation of Regulation (EC) N°1107/2009
Documents offer harmonised approach for implementation of EU rules
The European crop Protection Association (ECPA) has recently published a Technical Guidance Paper on a process to be followed for notification of potentially harmful effects, as required under Article 56 of Regulation (EC) N° 1107/2009.
ECPA has now developed a number of Technical Guidance Papers with the aim to have common standards that can be used by industry to provide standardised submissions within the framework of Regulation (EC) N° 1107/2009.
The Technical guidance Papers are available on the ECPA website at http://www.ecpa.eu/information-page/regulatory-affairs/technical-guidanc...
These documents have been prepared by ECPA experts in order to provide applicants with a harmonised approach for implementation of the EU rules in cases where the details have not been provided by EU legislation or guidance document.
The following Technical Guidance Papers (TGP) have been developed by ECPA and are available on the website:
- TGP N° 2011/1: Preparing a concise efficacy summary within the framework of the draft Registration Report (dRR), part of the Core Assessment relevant for EU product evaluations
- TGP N° 2012/1: Preparing a concise efficacy summary for the submission of a new active substance
- TGP N° 2012/2: Submitting efficacy information for re-registration submissions after a substance renewal
- TGP N° 2012/3: Process for the identification, assessment, communication and archiving of notifications of potentially harmful effects, as required under Article 56 of Regulation (EC) No. 1107/2009