Draft assessment report

The decentralised procedure can be used in cases where the product has never been authorised in any of the Member States, and the applicant wishes to obtain a license in a number of states simultaneously. The applicant must submit applications with the complete dossier to the Competent Authorities of each of the Member States where authorisation is desired. A single Member State should be chosen as the reference state to undertake the scientific assessment ofthe complete dossier, while the other states are designated as concerned states. The review process has many parallels vhth the centralised procedure, in that similar time lines exist, the reference State plays the role ofthe rapporteur, and the concerned States replace the CHMP. Once all States have validated that the dossiers are complete, the reference State is allowed 70 days to review the dossier and prepare a preliminary assessment report, which is circulated to the concerned Member States and the applicant. Comments from the concerned Member States and applicant responses are collected so that by day 120 the reference State may issue a draft assessment report together vhth draft SPC, label and leaflet texts. The clock may be stopped until requested responses from the applicant are received. The application then enters the second step in the assessment process, during which all the concerned Member States consider the... 

Draft assessment report, SPC, Labels, leaflet (Reference CA)... 

EFSA (2008) Final addendum to the Draft Assessment Report (DAR), Bifenthrin, public version. Background document A, pp 685, European Food Safety Authority, Parma, http // www.efsa.europa.eu/en/scdocs/scdoc/186r.htm... 

After submission, the rapporteur and corapporteur have 120 days for their review and to write a draft assessment report. The two assessments are then discussed by the parties and a list of outstanding issues are sent to the sponsor at which point the clock is stopped. After the answers have been received, the rapporteur has a further 30 days to finalize the assessment report, which is sent to the CPMP or CVMP. The CPMP/CVMP members also receive a copy of Part 1 of the dossier and may request the full dossier. After a total of 210 days, the CPMP or CVMP delivers an opinion, favorable or unfavorable. 

Where an applicant wishes to market a product in more than one Member State, an identical dossier will be sent to all relevant Member States. If an authorisation has not been previously granted, one Member State will be appointed by the applicant to act as RMS who will prepare a draft assessment report with a draft SPC and a draft of the labelling and package leaflet. The CMSs will have the opportunity to review and approve the documents. Therefore, conceptually, the decentralised procedure resembles the centralised procedure without the involvement of CHMP, representing consultation between the Member States before even the first marketing authorisation is granted. 

The CHMP renders its scientific opinion with an overall deadline of 210 days. The Rapporteur and Co-rapporteur prepare draft assessment reports during the first 70 days, and send them to the CHMP, the EMEA secretariat and the applicant. After exchange of comments and opinions between the Rapporteurs and the CHMP, a collated list of questions is sent to the applicant by day 120. The review clock is stopped at this point, and restarts with the applicant s response. If the applicant believes that more than six months are needed to answer the list of questions, then the application should be withdrawn. 

The Pesticide Risk Assessment Peer Review Unit (PRAPeR) of the European Food Safety Authority (EFSA) is responsible for the peer review of initial risk assessments of active substances. For each substance, a member state carries out this initial risk assessment, which is presented in a draft assessment report (DAR) that is then peer reviewed by experts across the European Union (EU) in a process... 

Before 210 CPMP opinion and CPMP draft Assessment Report. 

Prepare a draft assessment report containing, as a minimum ... 

A draft RI report should be produced for review by the support agency and submitted to the Agency for Toxic Substances and Disease Registry (ATSDR) for its use in preparing a health assessment and also to serve as documentation of data collection and analysis in support of the FS. The draft RI report can be prepared any time between the completion of the baseline risk assessment and the completion of the draft FS. Therefore, the draft RI report should not delay the initiation or execution of the FS. 

Environment Canada Health Canada Canadian Environmental Protection Act. Priority substance list assessment report nonylphenol and its ethoxylates. Draft, 2000. 

General Atomics. 2001k. Assembled Chemical Weapons Assessment (ACWA), Engineering Design Studies, Draft Test Report, February 10. San Diego, Calif. General Atomics. 

The first draft of the risk assessment reports are written by the Member States, which act as rapporteurs . Generally, one Member State acts as rapporteur for a prioritized substance or group of substances however, for some prioritized substances, more than one Member State can act as rapporteurs. The risk assessment process is coordinated by the ECB. Stakeholders are involved in the process through the Technical Committee for New and Existing Substances (TC NES). The Commission mediates the meetings, which attempt to reach consensus on the conclusions of the risk assessments. During the risk assessment process, the Scientific Committee on Health and Environmental Risks (SCHER) is requested to provide an opinion. 

Source Draft for Scientific Review, Intergovernmental Panel on Climate Change, Third Assessment Report. 

Lorton, G.A. Fromm, C.H. and Meltzer, M.P. 1988 (draft). Waste Minimization Assessment Report Case Study of Minimization of Stretford Solution Purge at an Oil Refinery. Jacobs Engineering Group, Inc Prepared for EPA Hazardous Waste Engineering Research Laboratory, Office of Research and Development, Cincinnati, OH. 

Environment Canada (2004) Environmental Screening Assessment Report on Per-fluorooctane Sulfonate, its Salts and its Precursors that Contain the C8F17S02 or C8F17S03 Moiety (Draft for Public Comments)... 

USEPA, 2001. Exposure and human health reassessment of 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) and related compounds (Draft Final Report, EPA/600/P-00/001Bc), Exposure Assessment and Risk Characterisation Group, National Center for Environmental Assessment, Office of Research and Development Washington DC. September 2001. 

The sources of unintentionally produced POP chemicals, polychlorinated dibenzodioxins (PCDD), polychlorinated dibenzofurans (PCDF), and hexachlorobenzene (HCB), has been estimated through the National Implementation Plan (NIP) for Malaysia. However, an official report has not been made public. The draft final report on the assessment of unintentionally produced chemicals conducted by Universiti Sains Malaysia... 

The primary task of SCHER is to review Risk Assessment Reports established according to the regulation on evaluation and control of risks of existing substances (EEC 1993). These reports evaluate the risks of prioritised substances, and they are drafted by member state rapporteurs and decided on through comitology procedures. The job of SCHER is to review the scientific quality of these reports, particularly with regard to how they specify risks to public health, consumers and the environment. The committee put together its review in an opinion , which basically clarifies what it considers to be the health and environmental risks of the substance under study. Opinions also discuss the level and conditions of scientific uncertainty as well as whether and, if so, what further research is called for. The Commission may also ask SCHER for advice on other specific issues, even if there is no RAR to review. 

There may also be legal obligations associated with the review results. A properly administered process safety management program will help minimize legal exposures. All recommendations produced by the study should be circulated in draft form to all interested parties within the company. The report should be consistent with other hazard assessment reports, and there should be a follow up procedure to manage recommendations in a timely and effective manner. All steps in the process should fully document the resolution path for each recommendation. 

European Commission (2008) Risk assessment report on hexabromocyclododecane. Final draft. May 2008, 492 pp. 

Health Canada, Priority Substances List Assessment Report 2-Butoxyethanol. Draft for Public Comments, Ministry of Public Works and Government Services, Ottawa, August 2000. Available at http //www.hc-sc.gc.ca/hecs-sesc/exsd/psl2.htm (accessed October 2004). 

The opinion of the CHMP may be subject to appeal the intention to appeal should be notified to the EMEA within 15 days after the opinion has been issued, and within 60 days the detailed grounds for appeal must be forwarded to the EMEA. A final opinion will be adopted by the CHMP within the following 60 days, together with an assessment report, stating the reasons for the conclusions reached. In the event of an opinion in favor of granting or maintaining a MA the opinion will include a draft SmPC, the proposed labeling and any condition deemed to be relevant for the safe and effective use of the product. This opinion will be sent within 15 days to MS, Commission and the applicant/MAH. 

Covello, V. von Winterfeldt, D. Slovic, P. "Risk Communication An Assessment of Literature on Communicating Information About Health, Safety, and Environmental Risks". Draft Preliminary Report to the EPA, Institute of Safety and Systems Management, University of Southern California, January 11, 1986. 

The Rapporteur and Co-Rapporteur then assess the applicanfs replies, submit them for discussion to the CHMP or CVMP, and, taking into account the conclusions of this debate, prepare a final assessment report which also includes the draft summary of product characteristics, the patient package leaflet and the texts proposed for the various packaging materials. 

In 2007, a survey on production and uses of SCCPs was undertaken in the framework of the United Nations Economic Comission for Europe (UNECE) POPs Protocol [9]. Based on the available data from the EU, Switzerland, Canada and the USA, production of SCCPs in the UNECE region was estimated to range from 7,500 tons per year to 11,300 tons per year (Table 4). According to the EU Risk Assessment Report, in 1994 SCCPs were manufactured within the EU by two producers, at a total quantity of <15,000 tons per year [8]. According to the updated draft Risk Assessment Report from August 2005 [10], SCCPs were produced by... 

According to this model, the atmospheric emissions of cadmium from Ni-Cd batteries treated in MSW incinerators are estimated to less than 0.5 tonnes/y in 2000. These data have been published in the last draft of the Risk Assessment Report on Cadmium and Cadmium Oxide (DRAR 2000) in November 2000. This value will be further reduced by two factors ... 

Cadmium releases from landfills have been evaluated by the Draft Risk Assessment Report on Cadmium (DRAR 2000). They can be evaluated at less than 0.3 tonnes/y, this representing less than 0.8% of total emissions of cadmium in water in the EU countries. The major contributors to total cadmium emissions into surface waters are zinc and lead producers, fuel combustion for electricity generation, fuel combustion for road transportation, phosphate industries and non-ferrous metallurgy (DRAR 2000). 

DRAR (2000) Draft Risk Assessment Report on Cadmium/Cadmium Oxide (2000). Belgian Rapporteur. Mr. M. De Win General Advisor. Ministry of Social Affairs,... 

FOCUS, Landscape and Mitigation Factors in Aquatic Ecological Risk Assessment. Report of the FOCUS Working Group on Landscape and Mitigation Factors in Ecological Risk Assessment, draft 18 June 2004. http //viso.jrc.it/focus/. 

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