Scope 126 this module addresses the legal requirements detailed in title ix of directive 200183ec and chapter. Directive 2001 81 ec, on nation al emissions ceilings necd for certain atmospheric pollutants. Each application, whether authorised nationally or through mutual recognition, must be accompanied by the eu application form in order for it to be validated. L 7714 en official journal of the european communities 16. B directive 200183ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use oj l 311, 28. Directive 2001 83 ec should be amended in order to respond to this increasing threat. Directive 200183ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use.
B directive 2001 83 ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use oj l 311, 28. Regulation ec no 10492001 of the european parliament and. Decision n0 24552001ec of the european parliament and of the council of 20 november 2001. Commission directive 200122ec of 8 march 2001 laying down. Pagina data m1 directiva 200298ce a parlamentului european. Worldview2 pansharpening chris padwick1, principal scientist michael deskevich2, sr. Review of eu legislation from directive 200183ec to date food. Guideline on good pharmacovigilance practices gvp module vi ema87382011 page 584 124 vi.
Council directive 200385 ec of 29 september 2003 on community measures for the control of footandmouth disease repealing directive 85511 eec and decisions 89531eec and 91665eec and amending directive 9246eec text with eea relevance the council of the european union, having regard to the treaty establishing the european com. Article 1 paragraph 1 the purpose of this directive is to ensure that products placed on the market are safe. Commission directive 200394ec the commission of the. Procedures guide of the european competition authorities eca. Council directive 2001 23 ec of 12 march 2001 on the approximation of the laws of the member states relating to the safeguarding of employees rights in the event of transfers of undertakings, businesses or parts of undertakings or businesses official journal l 082, 2203 2001 p. Since the enactment of directive 200183ec community code. The methodology for the identification and management process of the signal were defined in the implementing regulation eu n. The resulting merged pdf file will contain all documents in the order as they appear on the screen. Software engineer fabio pacifici1, principal scientist scott smallwood1, sr. Directive200183ec europeanparliament november2001 communitycode relating medicinalproducts humanuse europeanparliament europeanunion, having regard treatyestablishing europeancommunity, particulararticle 95 thereof, having regard proposalfrom commission.
Official journal no page date m1 directive 200298 ec of the european parliament and of the council of 27 january 2003 l 33 30 8. The directive dealt with the disparities between certain national provisions, in particular between provisions relating to medicinal products, which directly affected the functioning of the. Software engineer 1 digitalglobe, 1601 dry creek drive, suite 260, longmont co, 80503, usa 2 itt visual information solutions, 4990 pearl east circle, boulder co, 80301, usa. Directive 200120ec, defines rules for the conduct of clinical trials. Directive 200120ec of the european parliament and of the. Directive 2001 83 ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use oj l 311, 28. And disposition of jurisdictional facilities issued march 9, 2012 1. Having regard socialcommittee procedurelaid down article251 councildirective 6565eec 26january 1965 provisionslaid down law,regulation. After that use drag and drop to bring the files in the desired order. Pdf on oct 26, 2015, w w lautt and others published 2001 find, read and cite all the research you need on researchgate. This document is meant purely as a documentation tool and the.
Directive 200528ec, defines good clinical practice for design and conduct of clinical trials. Trade commission did an investigation of the 2001 merger between. Directive 2001 83 ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use l311 2001 1128 20081231 32006l0040 eu 27 directive 200640 ec of the european parliament and of the council of 17 may 2006 relating to emissions from air. Directive 200953 ec of the european parliament and of the council of 18 june 2009 amending directive 2001 82 ec and directive 2001 83 ec, as regards variations to the terms of marketing authorisations for medicinal products oj l 168, 30. It applies to all the products which are intended for consumers or likely to be used by consumers even if not intended for them, and are supplied or made available, whether for consideration or not, in the course of a commercial activity, and whether new, used or reconditioned. Directive of the european parliament and of the council on the community code relating to medicinal products for human use. Council directive 200385ec of 29 september 2003 on. Note the packaging of medicinal products placed on the market and incorporating tamper verification features in accordance with this international standard meets, as an example but not limited to, the requirements of directive 2001 83 ec 1 as amended by directive 201162eu. Directive 200185ec number of doors issue in a m2 vehicle taam query results page 4 5 verdict member state yes no comment justification germany e1 9 the minimum requirement of one service door and one emergency door will only be fulfilled if access to the emergency doors is ensured as laid down in item 7. An overview of the general product safety directive 200195ec. European parliament and of the council regulation ec 19012006 of 12 december 2006 on medicinal products for paediatric use and amending regulation eec no 176892, directive 2001 20 ec, directive 2001 83 ec and regulation ec no 7262004. Directive 200195 ec product safety safety and health at. Directive 2001 83 ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use the european parliament and the council of the european union, having regard to the treaty establishing the european community, and in particular article 95 thereof.
Annual report 2001 7 investec group limited 31 march 31 march investec group limited 2001 2000 % increase headline earnings attributable to ordinary shareholders rmillion 1 314 1 047 25,5 headline earnings per share cents 1 628,2 1 300,9 25,2 dividends per share cents 750 620 21,0. The commission of the european communities, having regard to the treaty establishing the european community, having regard to directive 200183ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use 1, as last amended by commission directive 200363ec 2, and in. Directive 2002 98 ec of the european parliament and of the council of 27 january 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending directive 2001 83 ec official journal l 33, 08022003, p. Directive 9341eec, establishes the european agency for the evaluation of medicinal products. What type of organisations should register with eudravigilance. Emission reduction targets for the new eu10 member states have been specified in the treaty of accession to the european union 2003 the treaty of accession 2003 of the czech republic, estonia, cyprus, latvia, lithuania, hungary, malta, poland, slovenia and slovakia. Ce marking is currently required for many products sold in europe, yet many u. Eudravigilance registration ema3530072016 page 39 1. You can either select the files you want to merge from you computer or drop them on the app using drag and drop. Council directive 200123ec of 12 march 2001 on the. Directive 200183ec of the european parliament and of the. The european parliament adopted a legislative resolution at its first reading on 24 november 2010.
Official journal no page date m1 directive 200298ec of the european parliament and of the council of 27 january 2003 l 33 30 8. This webapp provides a simple way to merge pdf files. Guide to renewal of marketing authorisations human medicines. Orphan medicinal products in europe and united states to. Directive 2001 83 ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use. The current version of the gpsd came into force 15th january 2004. On may 20, 2011, as amended on october 11, 2011, exelon corporation exelon and constellation energy group, inc. Directive 2001 20 ec of the european parliament and of the council of 4 april 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Regulation ec no 1049 2001 of the european parliament and of the council of 30 may 2001 regarding public access to european parliament, council and commission documents as amended by the commissions proposal the european parliament and the council of the european union. This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents b directive 2001 82 ec of the european parliament and of the council of 6 november 2001 on the community code relating to veterinary medicinal products oj l 311, 28. Having regard to directive 2001 83 ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use1, as last amended by commission directive 200363 ec 2, and in particular article 47 thereof. Directive 200181ec, national emission ceilings european. November 2001 zur schaffung eines gemeinschaftskodexes fur humanarzneimittel. Study on the availability of medicinal products for human.