Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisa tion holders to the european medicines agency in. Council regulation ec no 286698 31 december 1998 author. Council regulation ec no 116598 of 19 may 1998 concerning shortterm statistics. Official journal no page date m1 commission decision 2009240 ec of 4 march 2009 l 71 23 17. The european parliament and the council of the european union, having regard to the treaty establishing the european community, and in particular article 100a thereof, having regard to the proposal from the commission 1. B regulation ec no 25897 of the european parliament and of the council of 27 january 1997 concerning novel foods and novel food ingredients. The prospectus directive and accompanying regulation establish a harmonised format for prospectuses in europe and allow companies to use the same prospectus prepared for admitting securities to trading on. Decision 211998 network for surveillance and control of. A bsi guide to the in vitro diagnostic directive introduction in vitro diagnostics ivd is an essential and fast growing part of the global healthcare system, as they add value to patients, medical professionals and the industry along with enhancing the wellbeing. This behavior has nothing to do with the signing engine e. Directive 200954 ec of the european parliament and of the council 7 and directive 200183 ec of the european parliament and of the council 8. Thank you for using the download pdf file feature, to download a correct pdf file, please follow the steps. Neither the european commission nor any person acting on behalf of the commission or any author of this report is responsible for the use which might be made of this publication. Commission regulation ec no 157098 of 17 july 1998.
The code of federal regulations cfr annual edition is the codification of the general and permanent rules published in the federal register by the departments and agencies of the federal government produced by the office of the federal register ofr and the government publishing office. Commission of the european communities brussels, 10 05 1996 com96 184 final 950182 cod amended proposal for a european parliament and council regulation ec amending council regulation eec no 2992 establishing the community customs code presented by the commission pursuant to article 189 a 2 of the ectreaty. Commission implementing decision of xxx authorising the placing on the market of citicoline as a novel food ingredient under regulation ec no 25897 of the european parliament and of the council only the german text is authentic the european commission, having regard to the treaty on the functioning of the european union. Commission regulation ec no 262004 on the community. Decision no 2119 98 ec of the european parliament and of the council of 24 september 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the community official journal l 268, 0310 1998 p. Guidance explaining the main features of the in vitro diagnostic medical devices directive 9879ec. The commission of the european communities, having regard to the treaty establishing the european community, having regard to regulation ec no 8522004 of the european parliament and of the council of 29 april 2004 on the hygiene of foodstuffs 1, and in particular article 1 thereof, whereas. Commission directive 201214eu of 8 may 2012 amending.
However, directive 200954 ec deals with both natural mineral waters and spring waters, and only the former category should be exempted from the scope of this directive. Statutory instrument food safety authority of ireland. B directive 9879 ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices oj l 331, 7. Council regulation ec no 116598 of 19 may 1998 concerning shortterm statistics 5 established a common framework for the collection. Commission communication on the community marketing authorisation procedures for medicinal products 98 c 22903 introduction as part of the overall strategy for building a single market for pharmaceuticals, a series of new procedures for granting marketing authorisations were introduced. B regulation ec no 25897 of the european parliament and of. L 14218 en official journal of the european communities 14.
The council of the european union, having regard to the treaty establishing the european community, and in particular article 43 thereof. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with regulation ec no 19072006 the reach regulation. The panel wishes to thank for the preparatory work on this scientific opinion. Even if you have a file with sensitive data and want to convert this excel document to pdf format, pdf candy is an online service you can rely on the files content is protected and kept 100% secure. Commission regulation ec no 8897 of 20 january 1997 on the authorization of the exemption of imports of certain bicycle parts originating in the peoples republic of china from the extension by council regulation ec no 7197 of the antidumping duty imposed by council regulation eec no.
Departmentof transportation officeofthesecretary oftransportation generalcounsel 1200newjerseyavenue,s. Proposal for a directive of the european parliament and of the council amending council directive 93eec of 5 april 1993, directive 986ec o f the european parliament and of the council, directive 200529ec of the european parliament and of the council and directive. Tolerable upper intake levels for vitamins and minerals european food safety authority. Guidance group 1 comprises those substances and mixtures, as defined in points 7 and 8 of article 2 of regulation ec no 12722008 of the european parliament and the council on classification, labelling and packaging of substances and mixtures the clp regulation. Pdf files are a common format for most businesses today. B directive 200868 ec of the european parliament and of the council of 24 september 2008 on the inland transport of dangerous goods text with eea relevance oj l 260, 30. Considering the communication from the commission to the council and the european parliament on an eu action plan for forest law enforcement, governance and trade. Substance name ec number cas number 51 with lead pb content above the applicable generic concentration limit for toxicity for reproduction repr. Aiim serves as the administrator for pdf a, pdf e, pdf ua and pdf h.
Council regulation ec no 3081999 of 8 february 1999. At this time we do not yet have information on identified restrictions. Commission implementing regulation eu 2015 1998 of 5. If the root ca that issued the signing certificate is not included in adobe trusted identities, the digital signature is considered not trusted but not invalid when the document is opened in adobe reader see example below. B directive 98 79 ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices oj l 331, 7. Drinking water legislation environment european commission. The prospectus directive 200371 ec pd and the commission regulation on prospectuses ec no 8092004 became effective on 1 july 2005. Easy to use online pdf editor sejda helps with your pdf. Herman, assistant administrator for enforcement and compliance assurance signed rapid clean up of rcra corrective. Regulation ec no 25897 of the european parliament and of.
Directive 201219eu of the european parliament and the council11, in addition to the. Ec no 1782002, the scientific advice provided by the previous scientific committees. To download the reader, which is freeware, connect to the adobe systems inc. They laid out a set of market parameters for the ec, including essential health and. European parliament and of the council, and repealing regulations ec no 5522004. These regulations may be cited as the european communities hygiene of foodstuffs regulations 2006. No watermarks, no file size limits convert pdf to excel spreadsheets in seconds. List of active molecules in biocidal products classified on the basis of chemical groups. The council of the european union, having regard to the treaty establishing the european community, and in particular article. Scientific opinion on the substantiation of health claims. The drinking water directive council directive 98 83 ec of 3 november 1998 on the quality of water intended for human consumption concerns the quality of water intended for human consumption.
Regulation ec no 5612006 of the european parliament and of. Having regard to council regulation ec no 99498 of 7 may. It also takes account of the provisions of regulation ec no 7652008 relating to market surveillance, which apply in a complementary way. Regulation ec no 2612004 of the european parliament and of the council of 11 february 2004 establishing common rules on compensation and assistance to passengers in the event of denied boarding and of cancellation or long delay of flights, and repealing regulation eec no. After conversion, you can see that there are following files listed in output folder. Open the online pdf editor with safari or your other favourite browser.
Council regulation ec no 85098 of 30 march 1998 for the. Council regulation ec no 253398 23 november 1998 author. The lifting operations and lifting equipment regulations 1998. Commission regulation eu no 2712010 of 24 march 2010 union. Commission regulation eu no 140720 of 18 december 20. Its objective is to protect human health from adverse effects of any contamination of water intended for human consumption by ensuring that it is. Directive 9872ec of the european parliament and of the council of 15 octo ber 1998.
L 33032 en official journal of the european communities 5. Additionally, pdf for healthcare pdf h is an aiim proposed best practice guide. The ferricytochrome b5 produced is reduced by nadh and ec 1. Council regulation ec no 116598 of 19 may 1998 concerning. Directive 9723 ec of the european parliament and of the council of 29 may 1997 on the approximation of the laws of the memb er states concerning pressure equipment the european parliament and the council of the european union having regard to the treaty establishing the european community, and in particular article 100a thereof. At this time we do not yet have information on identified uses. Pursuant to regulation ec no 14512007, nitrogen has. Commission regulation ec no 698 of 18 march 1998 amending annexes ii, iii and iv of council regulation eec no 237790 laying down a community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin text with eea relevance the commission of the european communities.
Cvce all rights of reproduction, public communication, adaptation, distribution or dissemination via internet, internal network or any other means are strictly reserved in all countries. Directive 9824ec risks related to chemical agents at. Commission regulation ec no 1570 98 of 17 july 1998 amending annexes i to iv to council regulation eec no 237790 laying down a community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin text with eea relevance the commission of the european communities. In the spring of 2008 the iso 32000 document was prepared by adobe systems incorporated based upon pdf reference, sixth edition, adobe portable document format version 1. Europe direct is a service to help you find answers. Pdfill allows users to alter existing pdfs or create documents from scratch.
Regulation eec no 230993, directive200182 ec of the european parliament and of the council39 and directive 200183 ec of the european parliament and of the council40. Drag and drop your file to our pdf to excel converter. Pursuant to point 4a of part iii of annex ii to directive 200948 ec, formaldehyde may be used up to a concentration of 0,1 %, which corresponds to mgkg content limit. Technical notes for guidance tnsg and other technical guidance documents were developed for the implementation of the biocidal products directive 98 8 ec bpd to enable industry and competent authorities to fulfil their requirements under the bpd. The guide takes account of the amendment to directive 200642 ec introduced by regulation ec no 5692009 relating to the regulatory procedure with scrutiny for the machinery committee. Commission implementing regulation eu 2015 1998 of. Official journal no page date m1 regulation ec no 18822003 of the european parliament and of the council of 29 september 2003 l 284 1 31. Document management portable document format part 1.
Proposal for a directive of the european parliament. Decision no 211998 ec of the european parliament and of the council of 24 september 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the community official journal l 268, 0310 1998 p. Commission regulation eu no 2712010 of 24 march 2010 amending regulation ec no 8892008 laying down detailed rules for the implementation of council regulation ec no 8342007, as regards the organic production logo of the european union the european commission, having regard to the treaty on the functioning of the european union. Thank you for using the download pdf file feature, to. Directive 19994 ec of the european parliament and of the council of 22 february 1999 relating to coffee extracts and chicory extracts the european parliament and the council of the european union, having regard to the treaty establishing the european community, and in particular article 100a thereof, having regard to the proposal from the. Decision 211998 network for surveillance and control of diseases. This text file contains the central index key cik numbers, company names, sec reporting file numbers, and addresses business addresses are provided when mailing addresses are not available of active brokerdealers who are registered with the sec. Directive 200898ec of the european parliament and of the council of 19. Commission regulation ec no 342003 of 25 july 2003. It would be consistent to apply the same procedure to introduce the proposed amendments to regulation ec no 2531 98.
Table 2 list of active substances in biocidal products and their mode of action. Directive 98 79 ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices. Having regard to regulation ec no 3002008 of the european parliament. B council regulation ec no 85098 of 30 march 1998 for the.
Commission implementing regul ation eu 2015 1998 of 5 november 2015 laying down detailed measures for the implementation of the common basic st andards on aviation secur ity text with eea relevance the european commission, having regard to the treaty on the functioning of the european union. M4 regulation ec no 18822003 of the european parliament and of the council of 29 september 2003 l 284 1 31. Regulation ec no 5612006 of the european parliament and of the council of 15 march 2006 on the harmonisation of certain social legislation relating to road transport and amending council regulations eec no 382185 and ec no 2598 and repealing council regulation eec no 382085 text with eea relevance. Regulation ec no 1782002 of the european parliament and of the council of 28 january 2002 laying down the general principles and requirements of food law, establishing the european food safety authority and laying down procedures in matters of food safety oj l 31, 1. Having regard to council regulation ec no 21732005 of 20 december 2005 on the establishment of a flegt licensing scheme for imports of timber into the european community2. Commission regulation ec no 260598 of 3 december 1998 amending regulation ec no 176895 implementing rules on the agricultural exemption provided for in article 143 of council regulation ec no 210094 on community plant variety rights the commission of the european communities, having regard to the treaty establishing the european. Commission regulation ec no 157098 of 17 july 1998 amending annexes i to iv to council regulation eec no 237790 laying down a community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin text with eea relevance the commission of the european communities. Rcracercla senior policy managers regional counsels from. Material safety data sheet according to 19072006ec. Understanding the machinery directive 2006 42ec brief history. In 1985, a series of new approach principles were introduced into the european community ec that would enable the free movement of goods across the region.
Commission communication on the community marketing authorisation procedures for medicinal products 98c 22903 introduction as part of the overall strategy for building a single market for pharmaceuticals, a series of new procedures for granting marketing authorisations were introduced. Guide to application of the machinery directive 200642ec. Proposal for a directive of the european parliament and of the council amending council directive 93eec of 5 april 1993, directive 986ec of the euro pean parliament and of the council, directive 200529ec of the european parliament and of the council and directive. Council directive 9858 ec of 20 july 1998 concerning the protection of animals kept for farming purposes. Directive 9723ec of the european parliament and of the council of 29 may 1997 on the approximation of the laws of the memb er states concerning pressure equipment the european parliament and the council of the european union having regard to the treaty establishing the european community, and in particular article 100a thereof. On 23 november 1998, the council adopted regulation ec no 2531 98 concerning the application of minimum reserves by the european central bank 3. Council regulation ec no 85098 of 30 march 1998 for. Commission regulation ec no 6 98 of 18 march 1998 amending annexes ii, iii and iv of council regulation eec no 237790 laying down a community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin text with eea relevance the commission of the european communities. Regulation ec no 148894 as well as council directive. Commission regulation ec no 19982006 of 15 december. Fix cannot open pdf files in windows 7, 8 1, 10 youtube. Regulation ec no 5612006 of the european parliament and of the council of 15 march 2006 on the harmonisation of certain social legislation relating to road transport and amending council regulations eec no 382185 and ec no 25 98 and repealing council regulation eec no 382085 text with eea relevance.
Council directive 9883ec of 3 november 1998 on the. Guidance and other relevant documents on the implementation of directive 98 8 ec. Regulation ec no 1772008 of the european parliament and of. The liver enzyme is an enzyme system involving cytochrome b5 and ec 1. It is classified as carcinogenic category 1b under regulation ec no 12722008. On 1 january 1995, two new procedures for the authoru.
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