Technical Guidance Papers - Common standards for product dossier submissions

Introduction

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: 

 

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:

 

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: 

Supporting documents

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    ECPA TGP 2012 - Efficacy Annex I

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    ECPA TGP 2012 - Efficacy Annex I

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    ECPA TGP 2012 - Efficacy Annex 2

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    ECPA TGP 2012 - Efficacy Annex 2

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    TGP 2012 - Article 56 Notification Process

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    TGP 2012 - Article 56 Notification Process

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    ECPA Efficacy dRR TGP

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    ECPA Efficacy dRR TGP

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