R4BP 3.10 and SPC editor key users testing Introduction to the new features 25 September 2017 Roberto Gilioli European Chemicals Agency

Overview Agenda of the day Objectives and scope of the testing Perform the testing and report feedback Items for implementation in 2018

Agenda of the day 1

Introduction to the testing exercise Agenda   25 September 2017 09:30 – 10:30 Introduction to the testing exercise 10:30 – 10:45 Coffee break 10:45 – 13:00 Testing of R4BP 3.10 beta 13:00 – 14:00 Lunch break 14:00 – 15:30 15:30 – 15:45 15:45 – 17:00 New features for 2018 and wrap up 17:00 END After-hour plans 18:00 - … Informal get-together Now you can transfer only assets

Objectives and scope of the testing 1

Objectives Get familiar with the new features of R4BP 3.10 Test the usability Provide early feedback Discuss the scope of R4BP 3 development in 2018 Now you can transfer only assets

Main features in R4BP 3.10 User interface improvements Communication improvements Mutual recognition of same biocidal products Synchronisation of NA-APP and NA-MRP Redefinition of active substance Submission of information post approval of active substance Now you can transfer only assets

User interface improvements

Relation diagram

More features of the diagram Clicking on any rectangle or circle will open in a new tab the corresponding case or asset details. The case type is reported in each rectangle Circle's border is dotted: the asset is a family member Label of a circle not bold: the current user cannot access the asset details No case type number in the circle: it is migrated!

Enhanced case and assets details export Fields exported in worksheet: Dossier UUID Evaluating authority Submission date Case status Completed on Target Asset number Implementing regulation decision Decision date Case owner name Asset owner name Case number Product/Substance name Trade name(s) Active substances Product type(s) BAS number EC number CAS number IUPAC name Case type

Search cases/assets also by company name

New filter criteria Assets generated from NA-MRS, NA-MRP, NA-BBP and NA-BBS

More multi-select fields For cases and assets

Calendar selection for reply by date No more counting of days…

Additional improvements Possible to select multiple PTs per single use in the SPC editor Improved message for SPC format error Fixed the Invalid XML SPC error when pasting text with special characters in the editor No more automatic message sent to applicant when a case is resumed by ECHA

Improved communication

Better search and… archive!

Case owners can initiate a communication with evaluating CAs

Process flow enhancements

Mutual recognition of SBP professional & public uses professional & public uses public uses (25 ppm) MR MR SBP public uses (25 ppm) professional & public uses public uses (25 ppm) MAC MR

Mutual recognition of SBP professional & public uses professional & public uses public uses (25 ppm) MR NOW PERMITTED! MR SBP public uses (25 ppm) professional & public uses public uses (25 ppm) MAC MR

One LE can hold more than one NA (SBP) per product per market area As a consequence are allowed: Multiple Mutual recognitions of SBP in the same market where the reference product already holds a Mutual recognition Multiple NA (SA, UA) in the same market for the same product Multiple MR having the same reference NA Multiple SA or UA (or both) for the same product

Synchronisation of NA-APP and NA-MRP Agreement scenario

Synchronisation of NA-APP and NA-MRP Disagreement scenario

Synchronisation of NA-APP and NA-MRP New task items

Synchronisation features "Evaluate and draft PAR & SPC(s)“ (EVP) by rMS has to be concluded within 365 days. "Agree on SPC" (ASP) must be concluded within 90 days. If cMS does not respond in 90 days, silent agreement is assumed! rMS should grant authorisation first!

Streamlined notifications (SN-NOT) Notify one or more members of a family in one wizard Notify one or more single products in one wizard

New SPC “component” for upload

Select assets 2 1 3

Redefinition of an active substance

Within the Review Programme Supported: One substance redefined in another one One substance redefined in more than one substances Many substances redefined in one substance

Change (correct) Active substance

Additional features Scientific data update after active substance is approved (AS-UPD), (AN-UPD) – To Be Completed The evaluation timer for CAs in SA-APP after provision of further documentation by the applicant is restarted and set to 90 days Automation of ECHA processes Increased capability for data corrections

How to perform the testing and report feedback 1

Testing environment (Trasys) Trasys testing environment will be used today Instructions on how to access are available in your laptop Customised data are available for testing Now you can transfer only assets Feedback form to be filled in!

Plans for 2018

Features to be implemented in 2018 New case types Article 95 list amendments Active Substance cancellations Grouped NA-MIC and NA-MAC process synchronisation Workflow enhancements Support amendments or cancellations of markets where Union Authorisations are applicable Union Authorisation in EEA countries Enhancement of efficiency of internal ECHA processing of dossiers

Features to be implemented in 2018 User interface improvements: Further enhancement of the search functionality, (remember filter, search for reference MR, etc.) More information on the case available on process steps details (i.e. AS already applied for) Allow amendments of actions done by mistake Communication enhancements: further flexibility to the messaging system (cc feature) Improvements to the SPC editor “compare” feature “Find and replace” text in the SPC editor

Features to be implemented in 2018 Performance improvements Preparations for Brexit: Possibility to transfer reference case responsibility from one MS to another. Content check in applications (e.g. flag applications for Annex I of Active substances not eligible) Further improve error messages and alerts from the system

Thank you! roberto.gilioli@echa.europa.eu