Request for quotation questionnaire en iso 485, aimdd. Apply conformity assessment procedure annexes viii, ix, x, xi 7. A g id t s b ittia guide to submitting annex vii forms via. Send a copy of the completed annex vii form to sepa in advance of the shipment. Financial identification form using the standard template in. There are three medical device directives in place, the directive of active implantable medical devices 90385eec, the medical devices directive 9342eec, and the directive of in vitro diagnostic medical devices 9879ec. In general, the documentation has to be in such detail that the design, manufacture and the designed performances of the product can be evaluated, in order to prove compliance to the provisions of the aimdd 90385eec and the mdd 9342eec, respectively. Forms should be kept for a period of three years from the date when the shipment starts, by the person who arranges for the shipment, the consignee and the facility which receives the waste.
The form must be accompanied with a copy of the vat registration document and a copy of an official document showing name. Find the most uptodate version of icao annex 8 at engineering360. Part i is the written narrative that must be thorough and include specific details of the program services, manner and method of delivery including program services, client eligibility, subcontractor andor vendors that will provide services. The form must be accompanied with a copy of the vat registration document and a copy of an official document showing name, address and registration number. Cpanel accounts include autossl, app catalog and autoinstall, and more. Performancebased communication and surveillance pbcs. The person responsible for arranging the shipment must complete the form for each shipment before moving the waste. This information should be forwarded to the seoc using the form shown in. The ec declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by section 1 of the directive ensures and declares that the products concerned meet the provisions of the directive which apply to them. Assessment and guidance for the implementation of eu waste. Select conformity assessment procedure article 42 4. An assessment of the applicant agency, to be gleaned from the agency profile and capacity assessment form submitted with the proposal. Mds 7010 medical devices incorporating software utilizing softwarecontrolled by software.
Exporters, importers and consignees must keep copies of the forms for 3 years competent authorities can ask to see them. Name and address of the manufacturers european responsible person. Annex ii technical proposal form for lot 1 professional. Forms, permits and environmental impact assessment permits, notifications and registration transfrontier shipments of waste forms and document templates forms and document templates for waste shipments notification and movement documents. The dates were established so as to take account of the provisions of article 41 of the convention. It is a criminal offence to export green list waste other than in accordance with a fully completed annex vii form or without a valid contract in place. Annex vii list of documents plenary iccasp21 provisional agenda iccasp21add.
Annex vii forms must be kept by the person arranging the shipment, and not sent to us. Immediate assessment should be conducted to ascertain available resources that could be deployed to affected regions. Environment forms and document templates for waste shipments. Request for quotation questionnaire en iso 485, aimdd, mdd. Prac cal implica ons for manufacturers peter rose, jens weirsoe, and mike wolf june 2017 175 pages effective may 25, 2017 for more information, please contact.
Progress report for activities of the previous period. Application filled by applicants subbeneficiary project title scope of project and activity project description institution supportingsupervising the project. Annex vii forms via theannex vii forms via the national packagingnational packaging waste database npwd katie olley. Persistent offenders, or those engaging in fraud or misdescription, will be subject to more serious enforcement action, including prosecution. Annex a environmental screening form is an integral part of the environmental management framework, please read this document for guidelines. Jul 17, 2014 a letter was sent by the agency to exporters, producers, collectors and importers of waste yesterday july 16 to remind them of the requirement to fill out all sections of the annex vii form. Fp7 grant agreement annex vii form d version 5, 14. A revised text for annex 8 consistent with the above principles was prepared on the basis of the recommendations made by the third air navigation conference montreal, septemberoctober 1956. It does not tend to form a layer on the ground, unless the ground has a temperature that is below freezing, when it can form a dangerous layer of invisible ice on surfaces known as.
A medical device is defined in directive 9342eec as. You cannot use this system for recording annex vii forms. Annex i of machinery directive 200642 ecessential health and safety requirements applicable for design and manufacturing of machines general principlessummary of annex igeneral principles1. By signing the form, the person arranging the export certifies the information provided is correct and that the necessary contract has been entered into with the. Fp7 marie curie grant agreement annex vii, form e rea version of 14. For completing this document, see also the corresponding specific instructions as contained in annex ic of regulation ec no 102006. Canada, denmark, finland, germany, korea, the netherlands, norway, sweden, united kingdom, united states. Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of.
Icao annex 8 airworthiness of aircraft engineering360. Form request for quotation questionnaire en iso 485, aimdd, mdd, ivdd, aotse. The echa website is temporarily down for maintenance. Medical device directive 9342eec annex vii, risk class i compilation of the ce mark technical file systematic consulting delivery starts with an experienced regulatory affairs consultant explaining the detailed compliance project plan based on the annex vii of the medical device directive to be implemented with their guidance by phone and emails. Executive order 129 public law 2005, chapter 92 source disclosure certification form. Completed tenderers identification form annex v completed legal entity form annex vii completed financial identification form annex viii if applicable, information and documentation on members of consortia and subcontractors as specified in. Application form application for engagement of the services of banks medical consultant bmc on contract basis with fixed hourly remuneration at reserve bank of india, dehradun. Annex vii fill out and sign printable pdf template signnow. Printing software subcontracting use of infra structure tel. The hci shall apply again for software certification using another software solution if remedial actions are no longer doable. Ec declaration of conformity and classification according to annex ix of the mdd. Identified critical humanitarian needs and gaps can be adequately addressed through the proposal. This software would be designed to meet both article 26 and reduce the.
Somca safety implications in performing software model coverage analysis one signed original of this tender submission form must be supplied, together with three copies. Annex vii list of documents united nations office of. In common with other new approach directives, the three medical device directives in place include provisions for mandatory ce marking of all products covered by them. Annex iivii to manual on methods and criteria for harmonized sampling, assessment, monitoring and analysis of the effects of air pollution on forests part x. Identify applicable essential requirements article 4, annex i 5. This information should be forwarded to the seoc using the form shown in appendix 8 to this annex. Such offending shows a failure of duty of care and creates an uneven playing field for those who make the effort to comply with. Fill out, securely sign, print or email your annex vii waste form instantly with signnow. Development of academic reference standards page 2 of 8 project code. Steps for class iia medical devices compliance ce marking. The implementation and enforcement of article 18 and annex vii the implementation and enforcement of articles 4950 as concerns article 18 and annex vii, that means that evaluation will include questions such as type of document requested as accompanying document national form or directly annex vii, mandatory.
The most secure digital platform to get legally binding, electronically signed documents in just a few seconds. Operational templates and guidance for ems mass incident. Page 2 of 4 of annex c software certification agreement as of july 2017. Regulation 4 documentation 1 in all documents relating to the carriage of harmful substances by sea where such substances are named, the correct technical name of each such substance shall be used trade names alone shall not be used and the substance further identified by the. Start a free trial now to save yourself time and money. Philhealth shall revoke the software certification if the hci failed to complete the remedial actions. See appendix 7 to this annex for a sample communications plan form. In urgent cases, please submit your question through the contact form. For completing this document, see also the corresponding specific instructions as contained in annex ic of.
Ten countries participated from europe, north america and asia. Annex iii regulations for the prevention of pollution by harmful substances carried by sea in packaged form. Regulation 4 documentation 1 in all documents relating to the carriage of harmful substances by sea where such substances are named, the correct technical name of each such substance shall be used trade names alone shall not be used and the substance further identified by the addition of the words marine pollutant. Part iii of the annex was limited to broad standards stating the objectives rather than the methods of realizing those objectives. The purpose of this document is to facilitate the preparation of the tender by providing an overview of the information and documents requested. The importer or consignee and if different the recovery facility must sign and complete the annex vii form at blocks and 14. Annex vii submission guide 1 created 24092012 annex vii submission guide for exporters this guide provides stepbystep instructions on how to submit an annex vii form prior to shipping green list waste. Annex b budget form with all required forms, s chedules, and signatures and required budget narrative.