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ECHA Communications AP 7.2 September 2017 CA meeting Hugues Kenigswald
CA-Sept17-Doc.7.2. ECHA Communications AP 7.2 September 2017 CA meeting Hugues Kenigswald Biocides assessment Unit 28 September 2017 2
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Content Status of biocides applications
Progress of the Review Programme Article 95 list: management of redefinitions and withdrawals IT tools: new features for 2017 and plans for 2018 4/22/2019
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Status of applications since EIO BPR*
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Progress Review Programme and approval new active substances
Status after BPC-21
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Redefinition of an AS (1/2)
Redefinition of an active substance is initiated by the eCA Current practice: eCA informs ECHA about the redefinition via and ECHA makes changes in R4BP 3 manually; In the future: eCA makes the redefinition in R4BP 3 and places the RP participants under the relevant substance entry. ECHA changes the Article 95 list based on the information received from the eCA; The ”old” active substance entry is removed from the Article 95 list and a Call for notifications to take over the role of RP participant is published on ECHA website; If a compliant notification(s) is received, the substance and company information is included in the List of compliant notifications. The “old” active substance entry becomes (again) a relevant substance after validation by the eCA of an application for its approval. Then it is included (back) in the Article 95 list. INTERNAL 4/22/2019
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Redefinition of an AS (2/2)
Alternative suppliers (if any) are initially moved under the ‘redefined’ substance entry. ECHA informs alternative suppliers of the redefinition, reasons that led for the redefinition and its consequences via R4BP 3. The alternative supplier shall inform ECHA which substance entry (i.e. old or redefined) is relevant for their active substance. INTERNAL 4/22/2019
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Withdrawal of last RP participant supporting an AS/PT combination (1/2)
When the last participant supporting an AS/PT combination withdraws, Last RP participant stays on the list until the status of AS/PT has been clarified. The inclusion reason is changed to ”Former RP participant”. In case of first withdrawal of all participants: A call for notifications to take over the role of the participant in the review programme is published. Status of AS/PT is indicated in the Article 95 List: Withdrawn – Call for notifications ongoing Withdrawn – Notified Withdrawn – Awaiting for non-approval decision INTERNAL 4/22/2019
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Withdrawal of last RP participant supporting an AS/PT combination (2/2)
If a compliant notification to take over the role of the RP participant is received, the substance and company information is included in the List of compliant notifications. The new RP participant is included in the Article 95 list after validation by the eCA of the application for the approval of the active substance. INTERNAL 4/22/2019
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User interface: enhanced search and export
For cases and assets
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User interface: relation diagram
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Search and archive communications
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Case owners can initiate a communication with evaluating CAs
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Process flow: case withdrawal
Now you can transfer only assets
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Process flow: case transfer
The second Legal Entity has to accept Now you can transfer only assets
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Mutual recognition of SBP
professional & public uses professional & public uses public uses (25 ppm) MR NOW PERMITTED! MR SBP professional & public uses public uses (25 ppm) MAC
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Grouping and synchronisation
Synchronisation of the evaluation between reference and concerned Member States in mutual recognitions: transparent process to increase efficiency Enabled grouped submissions of administrative changes not in mutual recognition (NA, SA, UA) Now you can transfer only assets
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New and improved processes
Amendment and cancellations of notifications for simplified authorisations Review of Active Substance Approval (AS-REV) (3.10) Essential Use Derogation (DE-APP) Redefinition of active substance Streamlined notifications of Simplified Authorisations Now you can transfer only assets
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Features planned for 2018 New case type to support article 95 list amendments Workflow enhancements : Amendments or cancellations of markets where Union Authorisations are applicable Union Authorisation in EEA countries User interface improvements: Remember filter in search functionality, Allow amendments of actions done by mistake
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Features planned for 2018 Communication: further flexibility in the messaging system Improvements to the SPC editor “compare” feature Find and replace text in the SPC editor Performance improvements Compare biocidal products Preparations for Brexit
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Thank you!
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