upcoming regulatory & policy changes with it impact · added value from r4bp: •monitoring of...
TRANSCRIPT
Upcoming regulatory & policy changes with
IT impact
8th BPR IT User Group Meeting 14 November 2016, Brussels
Dr Alfonso Las Heras
European Commission
DG SANTE, Unit E.4
Table of contents
� Legal basis and implications
� Added value from R4BP:
� Tracking of procedures
� Statistics & monitoring of BPR implementation
� Dissemination & support to enforcement authorities
� Regulatory and policy issues with IT impact:
� Closer monitoring of delays in refMSs
� Improvement of the MR phase
� SA procedure
� SBP procedures
� Others
Legal basis and implications
• Article 71. Register for Biocidal Products
• 71(1) ECHA shall establish and maintain R4BP
• 71(2). R4BP shall be the only platform for the exchange of information.
• 71(3). Applicants shall use the R4BP to submit applications & data for all procedures in the BPR
• 71(6). (….) CAs/COM shall update the information in R4BP: terms & conditions; SPC & PAR
Added value from R4BP:
• Tracking of procedures
• Relevant for review programme and product authorisation procedures
• Allows follow-up of the different procedural steps ("where we are")
• Tracks back communication with applicants ("when was done what") and/or other CAs (e.g. Article 48 issues)
Added value from R4BP:
• Statistics
• Huge data base enabling the generation of detailed statistics (e.g. product authorisations by asset type, MS, PT, AS, etc..)
• Pre-requisite: information in R4BP has to be up to date and accurate
• � MSs to close finalised cases and create the
relevant assets
Added value from R4BP:
• Monitoring of BPR implementation (deadlines)
• Allows measuring compliance with the relevant deadlines in the BPR or implementing legislation for the different procedural steps
• Possibility of quantifying delays: % of cases closed under/above the legal deadlines, median of delays, class distribution (e.g. very low vs. significant delays)
• Pre-requisite: information in R4BP has to be up to date and accurate
• � Need to split MR-P in 3 steps (refMS+MR+NA)
Added value from R4BP:
• Dissemination & support to enforcement authorities
• Key tool to facilitate the dissemination of SPCs and ARs (transparency)
• Pre-requisite: SPCs in R4BP have to be in xml format and complete
• R4BP (& dissemination platform in future): reference tools for inspectors when carrying out checks (e.g. label compliant with SPC)
• New BPF concept (CA-Nov14-Doc.5.8 - Final.rev1)
• SBP Regulation (as amended by IR 2016/1802)
• Addressed in R4BP release end October 2016
Regulatory & policy issues with IT impact:
Regulatory & policy issues with IT impact:
• Closer monitoring of delays in refMSs (MR-P)
• As agreed at the 66th CA meeting (actions list against delays):
• Currently one single period, until the authorisation is granted in all MSs (365+90+30)
• Need to monitor the evaluation phase by the refMS(validation + 365 days, clock stop excluded)
� Essential to identify delays impacting on other MSs
(Art. 89(2) of the BPR)
Regulatory & policy issues with IT impact:
• Improvement of the MR phase
• Adaptation to the new steps under discussion in the CG (after a pilot phase), with clear communication tools.
• .. but there is a need to address some requirements in the BPR in any case as a priority:
• Submission of the draft SPC and PAR to CMSs (Art. 34(4) of the BPR � start of the 90-day MR phase
• Record in R4BP of the agreed SPC by the refMS (Art. 34(5) of the BPR) � start of the 30-day NA phase
Regulatory & policy issues with IT impact:
• SA procedure
• Notifications under Article 27(1) of the BPR for family members:
• Notification to one MS of one/severall/all family members in a single notification.
• Notification to more than one MSs of one or more products following the notification to the e-CA of a new family member in accordance with Article 17(6) of the BPR
Regulatory & policy issues with IT impact:
• SBP procedures
• Application for MR-S of same products:
• The "three checks" rule will block the last step of the application where the reference product has been mutually recognised in the same cMS(s)
• ECHA is working on a solution by Q2 2017 to remove this rule for this particular case, while ensuring that consistency and security in the whole system is maintained
Search functionalities
• Comparative assessment
• Key functionality enabling:
• Identification of eligible alternative products (at EU level) by the refMS � best use of resources
• Search by "use description" in the SPC (e.g. mice/indoor/general public) or by the individual elements combined in a given use (e.g. user category, target organism, application method, RMMs, etc..)
� Promising features in the dissemination platform
Search functionalities
• Other relevant searches
• Linked to Article 47 issues and/or enforcement actions: e.g. all products containing…
• … an AS being a candidate for substitution within a PT,
• … a specific source of an active substance,
• … a given SoC or coformulant,
• ….. manufactured by a manufacturer or at a specific manufacturing site.
Sustainable use
• To be defined and agreed first…..
• Reporting of sale/use volumes?
• Identification of products with the best profile for human health, animal health and the environment?
Thank you for your attention
For further information:
Commission website:http://ec.europa.eu/health/biocides/policy/index_en.htm
https://circabc.europa.eu/w/browse/e947a950-8032-4df9-a3f0-f61eefd3d81b
ECHA website & Helpdesk on Biocides: http://echa.europa.eu/regulations/biocidal-products-regulation
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