ECPA publishes Technical Guidance papers for the implementation of Regulation (EC) N°1107/2009

The documents aim to encourage standardised submissions within the framework of Regulation (EC) N° 1107/2009. (Photo: 'viteez' Flickr)
The documents aim to encourage standardised submissions within the framework of Regulation (EC) N° 1107/2009. (Photo: 'viteez' Flickr)

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.

 

Note:

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