Dissemination November 2018

Slides:



Advertisements
Similar presentations
Chemicals Regulation Directorate (CRD)
Advertisements

Reference Document Management 1 European Railway Agency (ERA) Cross-Acceptance Unit P. Mihm 17/11/2010.
Decision making for AIR active substances
Project Communications Strategy Communications Plan EU Publicity Requirements Project Website Project Logo.
Product Authorisation Workshop on REACH and EU Biocidal Product Legislation in practice (Experiences from EU Industry) INT MARKT Belgrade, Serbia.
N° 1 The European railway Agency: an engine for the integrated railway area EFRTC, Vilamoura on June 24 TH 2005 Olivier PIRON 24 June 2005.
PATCH-WORLd PArenTs and CHildren Working, ORganising and Learning together 23/24 October 2009 Sofia Final Conference This project has been funded with.
Ministry of Energy, Development and Environmental Protection of the Republic of Serbia Development of the Ecoregister, a national metaregister for environmental.
Advisory group on fruit and vegetables 7 March 2008
An agency of the European Union Presented by: Emer Cooke and Truus Janse-de Hoog Update on Transparency Progress report from HMA/EMA TF on Transparency.
Paediatric Worksharing CMDh participation Work-sharing in Art 45 and 46 procedures Experiences in Art 29 procedures Presidency meeting 29 September 2011.
Federal agency for medicines and health products EC REGULATION 1901/2006 ON MEDICINAL PRODUCTS FOR PAEDIATRIC USE AND HOMEOPATHIC MEDICINAL PRODUCTS Marie-Anne.
Improving the quality and availability of migration statistics in Europe: - reviewing concepts and definitions to develop EU legislation for migration.
MARITIME AFFAIRS Slide DG Maritime Affairs and Fisheries Maritime Forum E-learning module.
Student SOLE Page – Living Page
Recording and Reporting Clinical Trial Results
European Commission Activities on Nitrites
Co-operating with the European Aviation safety Agency
Session II: System authority for ERTMS 4RP Trackside approval
R4BP 3.9 key users testing Introduction 4-5 May 2017 Roberto Gilioli
EBIOZIDE Maria Amon Brussels, CA-meeting March 2016.
R4BP 3.10 and SPC editor key users testing
UA – Same biocidal product SPC translation review
IUCLID 6 IUCLID for biocides Vienna 4 December 2017
Support to National Helpdesks
Public Hearing on EU authorisation procedure for pesticides - EFSA opinion on draft assessment reports and ECHA classification of active substances.
ECHA Communications AP 7.1 March 2016 CA meeting Hugues Kenigswald
Handling the “stop of the clock” in product authorisation
Applications for same biocidal products (NA-BBP)
(Follow-up of the discussion at the 66th CA meeting)
Management of product authorizations for in situ cases
Management of product authorization for in situ cases (IGS)
Ag.13 Public Dissemination of documents
ECHA communications 78th CA meeting 29 May 2018 Hugues Kenigswald
Management of product authorisations for in situ generated AS : where are we? CA-July18-doc.4.5 5th July - Brussels.
Ag.no.14.1 Dissemination of A65
Vision on the future development of R4BP 3
ECHA’s Dissemination website
Biocides Dissemination
IT tool training Biocides Day 25th of October :30-11:15 IUCLID
Substitution of substances of high concern
State of play endocrine disruptors
Revision of the Annexes of the BPR
ECHA communications 80th CA meeting AP September 2018
State of play in the EU for criteria to identify endocrine disruptors
Ag.no.15.1 and 15.3 Dissemination of A65 data
Scope issues and referrals to the CG - background
Dissemination Working Group (DWG)
Updates from the 1st meeting of the Forum BPR Subgroup
REACH Registrations Advanced
Print, , Save Results TUTORIAL REACH Registrations Print, , Save Results
Ag.no Dissemination of A64 data
SBS Quality reporting item 4 of the agenda
Ag.no.6.1 Dissemination of A64
Biocides data dissemination
ECHA Communications AP 7.2 September 2017 CA meeting Hugues Kenigswald
Essentials (+) User Guides Data Sharing and Letters of Access under BPR (Regulation (EU) No 528/2012) CA Meeting 13 November 2014.
Security requirements
Management of product authorisations for in situ generated AS
BPR AS Review Programme
AP 4: ECHA - preparation of work under recast POPs Regulation AP 5: ECHA – Monitoring and reporting under recast POPs Regulation 19th Meeting of the Competent.
ECHA Communications AP 7.1 November 2017 CA meeting Hugues Kenigswald
Ag.No. 2 & 3 Action points from PY meeting
EUnetHTA Assembly May 2018.
Confidentiality claims assessment
WP on the implementation of the Biocidal product family concept:
Action Plan following the Active substance workshop
ECHA Communications AP 7.1 November 2015 CA meeting Hugues Kenigswald
How To Apply For UGC NET 2019 Exam Checkout The Full Process.
How To Apply For UGC NET 2019 Exam Checkout The Full Process.
Presentation transcript:

Dissemination November 2018 CA-Jan18-Doc.7.1 Dissemination November 2018 76th CA meeting AP 7.1 17 January 2018 Hugues Kenigswald Biocides Assessment Unit European Chemicals Agency

BPR requirements for BP

What will be disseminated In November 2018, improved biocides dissemination pages will be launched NA and SA/SN assets (UA will be disseminated earlier) From each authorisation granted the following documents will be disseminated: SPC finalised or updated after 1/1/16 PAR Authorisations/Decisions BPC opinion (UA)

Dissemination webpages Authorisation details

Assessment History (only the SPC will be disseminated)

MSCAs action requested in R4BP 3 By 30 September 2018 Make sure that assets and ongoing cases contain non confidential PAR, authorisations/decisions and properly filled SPC Make sure that the documents have the correct type/access level combination Be consistent in naming the PAR and authorisation documents If you realise that something is not ok…

R4BP 3 Data – Assets 1 NA, SA and SN 2

R4BP 3 Data – Assets 3 NA, SA and SN 4

R4BP 3 Data – ongoing cases 1 SPC NA, SA and SN 2 PAR NA and SA

R4BP 3 Data – ongoing cases Authorisation NA, SA and SN 4

Document type/access level combination (Public) UA, NA, MR, SA, SN assets  Document type Terms and conditions of the authorisation ((as per article 67(2)(a) i. e. a decision given by the CA at national authorisation level or Commission regulation at Union authorisation level) Authorisation or Decision Assessment report (as per article 67(4)(b)) Final assessment (or CA report, PAR)* BPC opinion (UA assets) Opinion The metadata in brackets should be preferably used for intermediate steps only (e. g. “CA report” metadata should be used by the eCA when completing EVL task, while ECHA would use “Final assessment” metadata for the assessment report finalised in the OPI task). The “CA report” uploaded in the EVL task should be claimed however “Restricted” or “Restricted-authority”. Nevertheless, even if the Doc Type metadata in the brackets is used but the level of access is set to “Public” at the final step of a process, the document will be published by ECHA on its website.

Conclusion Review the documents in the assets and in the ongoing cases. Mind the document type/access level combination Use meaningful filename for your documents as they will be disseminated under that name

biocides@echa.europa.eu Thank you!