Here you can find an archive of ECPA’s Technical Guidance Papers (TGPs). The first TGP was developed in 2011 and the aim is to have common standards that can be used by industry to provide standardised submissions to meet numerous requirements set out within the framework of Regulation 1107/2009.
ECPA Technical Guidance Paper No: 2012/1
Technical guidance for applicants in preparing a concise efficacy summary as part of a new active substance Annex I submission.
This Technical Guidance Paper has been developed to provide guidance for applicants in preparing a concise efficacy summary for the submission of a new active substance for inclusion in Annex I.
A separate TGP has been prepared to address the submission of efficacy information for Annex III re-registration submissions post Annex I renewal.
If you have any comments and/or suggestions for the further development of the Technical Guidance Paper, please send them to aurelie.dhaussy@ecpa.eu.
Attachments:
ECPA Technical Guidance Paper No: 2012/2
Technical guidance for applicants regarding the submission of efficacy information for product re-registration following inclusion of an existing active substance into Annex I
This Technical Guidance Paper has been developed to provide guidance for applicants in preparing the submission of efficacy information for Annex III submission following renewal of inclusion of an existing active substance in Annex I.
It does not address the question of new active substances and reference should be made to TGP 2012/1.
If you have any comments and/or suggestions for the further development of the Technical Guidance Paper, please send them to aurelie.dhaussy@ecpa.eu.
Attachments:
- TGP 2012-2 Efficacy AnnexIII Post-AnnexI Final (190Kb doc)
- TGP 2012-2 Efficacy AnnexIII Post-AnnexI Final (80Kb pdf)
ECPA Technical Guidance Paper No: 2012/3
Technical guidance for applicants regarding the notification of potentially harmful or unacceptable effects under Article 56 of Regulation (EC) No 1107/2009
This document provides authorisation holders with guidance on the 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.
This document does not substitute for the thorough reading of all articles mentioned and in particular Article 56.
If you have any comments and/or suggestions for the further development of the Technical Guidance Paper, please send them to aurelie.dhaussy@ecpa.eu.
Attachments:
- TGP 2012-3 Article 56 Notification Process (80Kb .doc)
- TGP 2012-3 Article 56 Notification Process (200Kb .pdf)
ECPA Technical Guidance Paper No: 2011/1
Technical guidance for applicants in preparing a concise efficacy summary as part of a draft Registration Report (dRR)
This Technical Guidance Papers has been developed to provide guidance for applicants in preparing a concise efficacy summary within the framework of the draft Registration Report (dRR), part of the Core Assessment relevant for EU product evaluations.
If you have any comments and/or suggestions for the further development of the Technical Guidance Paper, please send them to aurelie.dhaussy@ecpa.eu.
Attachments:
- TGP for applicants in preparing a concise efficacy summary as part of a dRR (130Kb doc)
- TGP for applicants in preparing a concise efficacy summary as part of a dRR (590Kb pdf)
ECPA Technical Guidance Paper No: 2012/4
Technical guidance on the application of the EFSA Guidance Document „Submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009“
This ECPA Guidance is based on the EFSA Guidance Document published on 28 February 2011 and incorporates extensive industry experience in the area of literature searches. This industry guidance aims at providing both a transparent and practical process for collecting, selecting and evaluating scientific peer-reviewed open literature, which should result in a manageable workload for both evaluators and applicants without jeopardizing the intention to ensure high level of protection for human and animal health and the environment.
If you have any comments and/or suggestions for the further development of the Technical Guidance Paper, please send them to peter.day@ecpa.eu.
Attachments: