References to the repealed decisions shall be construed as references to this regulation. The aim of the riskbased approach in the development of atmp s is to determine the extent of quality, non clinical and clinical data to be included in the m arketing authorisation application maa, in accordance with the. 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 use1, as last amended by commission directive 200363ec2, and in particular article 47 thereof, whereas. Directive 2001 18 ec as regards the possibility for the member states to restrict or prohibit the cultivation of genetically modified organisms gmos in their territory oj l 68. Article 1 directive 2001 83 ec is hereby amended as follows. Directive 200746ec of the european parliament and of the council of 5 september 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles. Directive 200118ec on the deliberate release of gmos into the environment regulates the.
Commission directive 2001 101 ec of 26 november 2001 amending directive 2000 ec of the european parliament and of the council on the approximation of the laws of the member states relating to the labelling, presentation and advertising of foodstuffs. Official journal no page date m1 regulation ec no 18292003 of the european parliament and of. Directive 200612ec of the european parliament and of the. Ec administrative procedure for granting consents for the deliberate release into the environment of gmos continue. Section d monitoring plan as required in annex vii of directive 2001 18 ec introduction transgenic carnation, and specifically the carnation line that is the subject of this proposal, now has a histoiy of safe use. Directive 2001 77 ec of the european parliament and of the council of 27 september 2001 on the promotion of electricity produced from renewable energy sources in the internal electricity market 1 oj l 283, 27. Definitionsdefinitions are provided for the terms adr, rid, adn international agreements, vehicle, wagon. Legal analysis of the applicability of directive 200118. 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. This directive replaces council directive 9455 ec, council directive 9649 ec and council directive 9635 ec. Pdf request from the european commission related to the. 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 internal market of the european union. Commission directive 200394ec the commission of the.
Directive 200410ec of the european parliament and of the. The indicator is developed for measuring the contribution to the 2020 objectives on renewable energy for the eu27. 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. Directive 2001 80 ec of the european parliament and of the council of 23 october 2001 on the limitation of emissions of certain pollutants into the air from large combustion plants. International environmental law volume 10, issue 3 the new directive 2001 18 ec on the deliberate release of genetically modified organisms into the environment. Council directive 9818ec of 17 march 1998 on safety rules.
What this means for clinical trial sponsors for clinical trials that ended on or after 21 july 2014, sponsors will have to post results within six paediatric clinical trials or 12 months non. Regulation eu 2017745 of the european parliament and of the council of 5 april 2017 on medical devices, amending directive 2001 83 ec, regulation ec no 1782002 and regulation ec no 12232009 and repealing council directives 90385eec and 9342eec text with eea relevance. Wtds291r wtds292r wtds293r page a5 request for further information, comments or reasoned objections by the commission or the member states. Directive 2004 18 ec of the european parliament and of the council of 31 march 2004 on the coordination of procedures for the award of public works contracts, public supply. Directive 200118ec of the european parliament and of the council of 12 march 2001 on the deliberate release into the. Articles 16, 33 under the current directive, dynamic purchasing systems in the following dps are structured around the open procedure, which entails major procedural complexities, not least the need for the indicative tenders as a condition for being admitted to system. Directive 200183ec of the european parliament and of the. Council directive 2001 23 ec of 12 march 2001 on the approximation of the. Directive 2001 80 ec of the european parliament and of the council of 23 october 2001 on the limitation of emissions of certain pollutants into the air from large. Directive 2001 45 ec of the european parliament and of the council of 27 june 2001 amending council directive 89655eec concerning the minimum safety and health requirements for the use of work equipment by workers at work second individual directive within the meaning of article 161 of directive 89391eec text with eea relevance. Official journal no page date m1 commission decision 2002623 ec of 24 july 2002 l 200 22 30. Regulation eu 2017745 of the european parliament and of. Cnl0010 to import 1507 maize has been submitted to the netherlands in accordance with directives 90220eec and 2001 18 ec. Annexes i, iv and xi to regulation ec no 999 2001 are amended in accordance with the annex to this regulation.
Objectivethis directive establishes a common regime for all aspects of the inland transport of dangerous goods, by road, rail, and inland waterway. Legislative texts directive 200918ec emsa european. Directives normally leave member states with a certain amount of leeway as to the exact rules to be adopted. German federal agency for nature conservation and prepared. Directive 87 18 eec is hereby repealed, without prejudice to the obligations of the member states concerning the time limits. Environmental risk assessments for medicinal products. European communities, council directive 75129eec of 17 february 1975. Practice has shown that tailormade procurement design e. This consolidated text includes directive 200118ec on the deliberate release of gmos into the environment, commission decision 2002623ec establishing guidance notes supplementing annex ii to directive 200118ec on risk assessment, regulation ec 18292003 on gm food and feed and regulation ec no 18302003 concerning the traceability and labelling of gmos. This document is meant purely as a documentation tool and. By agreement, it is also applicable in the eea, and compliance with the directive will ensure. The design of the procurement shall not be made with the objective of excluding it from the scope of this directive or of artificially narrowing competition. If the condition is a non interventional pass, it will be subject to the supervision set out in art 107 mq of directive 2001 83 ec and the format and content of such non interventional pass as described in implementing regulation 5262012 annex iii see gvp module viii. The proposal refers to this distinction which is based on the gpa also in other contexts.
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. A1 act of accession of austria, sweden and finland c 241 21 29. Annex 1, part iv of directive 2001 83 ec as amended by dir ective 2009120 ec. On 29 march 2006 greece notified the commission a request to prohibit for 18 months the marketing of seeds of 31 mon 810 varieties inscribed in the common catalogue. Directive 200118ec of the european parliament and of the council. The renewable energy directive 200928 ec is a european union directive which mandates levels of renewable energy use within the european union. B directive 2001 18 ec of the european parliament and of the council of 12 march 2001 on the deliberate release into the environment of genetically modified organisms and repealing council directive 90220eec oj l 106, 17. This text does not contain the annex to directive 200183 ec. Gm guidelines for the european food and drink industries.
The directive 200928 ec establishes an overall eu binding target of a 20 % share of renewable energy sources in energy consumption, as well as binding national targets by 2020 in line with the overall target. The implementation of directive 200120 ec in europe e. However, users are reminded that the text of the clp regulation is the only authentic legal reference and that the information in this document does not constitute legal advice. Directive as last amended by commission directive 2001 78 ec. The directive was published on 23 april 2009 and amends and repeals the 2001 directive on electricity production from renewable energy sources 2001 77 ec. In addition a separate application has been submitted to the.
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. Is the product being simultaneously notified to another member state. This document contains questions and answers on regulation ec no 12722008 clp regulation. B directive 200120ec 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 oj l 121, 1. This is a slightly amended translation of a paper which appeared in dutch in the tijdschrift voor gezondheidsrecht volume 33, number 6 october, 2009 p. Directive 200410 ec of the european parliament and of the council on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances codified version.
Directive 200180ec, large combustion plants european. Request pdf on feb 1, 2009, jeremy sweet and others published the environmental risk assessment of gm herbicide tolerant plants and the interplay between directive 2001 18 ec and directive 91. Directive 200118ec of the european parliament and of the council of 12. Directive 200118ec on genome editing technologies commissioned by the. Section d monitoring plan as required in annex vii of. This consolidated text includes directive 200118ec on the deliberate release of gmos into the environment, commission decision 2002623 ec establishing guidance notes supplementing annex ii to directive 200118ec on risk assessment, regulation ec 18292003 on gm food and feed and regulation ec no 18302003 concerning the traceability and labelling of gmos. That issue contained a special on the dutch act on medical research involving human subjects, the wmo. Directive 200118ec on the deliberate release into the.
The annex currently in force is laid down in commission directive 200363 ec of 25 june 2003 amending directive 200183 ec of the european parliament and of the council on the community code relating to medicinal products for human use official journal l 159, 2762003 p. Request from the european commission related to the safeguard clause invoked by austria on oilseed rape ms8, rf3 and ms8xrf3 according to article 23 of directive 2001 18 ec 1 scientific opinion of the panel on genetically modified organisms. M2 regulation ec no 18822003 of the european parliament and of the council of 29 september 2003 l 284 1 31. Decision 1999468 ec of 28 june 1999 laying down the procedures for the exercise of implementing powers conferred on the commission 1.
Context of the release as per the requirements of directive 2001 18 ec, this document presents an assessment of the possible risks to the environment following deliberate release of a genetically modified organism. Directive as amended by directive 2001 12 ec of the european parliament and of the council see page 1 of this official journal. Official journal no page date m1 directive 200298ec of the european parliament and of the council of 27 january 2003 l 33 30 8. Directive 200118ec of the european parliament and of the. Page 1 workshop manual zero turn mower zd21n ec,zd21 ec,zd28 ec kisc issued 09, 2006 a page 2 to the reader this workshop manual has been prepared to provide servicing personnel with information on the mechanism, service and maintenance of zd21n ec, zd21 ec and zd28 ec kubota zd series zero turn mower. This consolidated text includes directive 200118ec on the deliberate release of gmos into the environment, commission decision 2002623ec establishing guidance notes supplementing annex ii to directive. This is outlined in european commission guideline, in application of the current clinical trials directive 2001 20 ec and the paediatric regulation. The dangerous substances directive as amended was one of the main european union laws concerning chemical safety, until its full replacement by the new regulation clp regulation 2008, starting in 2016. After exit day no further amendments will be applied to this version. Guideline on the riskbased approach according to annex i. Directive on public procurement replacing directive 200418.
Directive 2001 83 ec of the european parliament and of the council show full title. Understanding the machinery directive 2006 42 ec the directive has been put in place because. The new directive 200118ec on the deliberate release of. The machinery sector is an important part of the engineering industry and is one of the industrial mainstays of the community economy. 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 notice to applicants, volume 2a procedures for marketing authorisation, chapter 3 union referral. Th hbv vv001 clinical study mvahbv directive 200118ec. I certify that the informaiton provided above is accurate and complete to the best of my knowledge and belief. Questions and answers on the regulation of gmos in the. Directive 200118ec of the european parliament and of the council of 12 march 2001 on the deliberate. Directive 200868ec inland transport of dangerous goods. The social cost of the large number of accidents caused by the use of machinery can be reduced by. Commission regulation ec no 20652001 of 22 october 2001. Article 21 of eu directive 200118ec defines an organism as any biological entity capable of replication or of transferring genetic material. Commission directive 2001101ec amending directive 2000.
L97482003 amending council directive 83477eec on the protection of workers from the risks related to exposure to asbestos at work. Directive 200145ec of the european parliament and of the. The directive requires that 20% of the energy consumed within the european union is. Greece based its measure on the safeguard clause of the common catalogue directive directive 200253 ec and of directive 2001 18 ec. Article 2 in article 1 of regulation ec no 26 2001, point 2 is deleted. Eu directives are being published on this site to aid cross referencing from uk legislation. Legal analysis of the applicability of directive 200118ec on.
Directive 200118ec on the deliberate release into the environment of genetically modified organisms. 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 6 lay. Under directive 2004 18 ec, the distinction between central government authorities and subcentral contracting authorities is relevant only for the determination of thresholds article 7 of directive 2004 18 ec. There is also sufficient history of use to support the fact that the biology of the. Directive 200918ec establishing the fundamental principles governing the investigation of accidents in the maritime transport sector and amending council directive 199935ec and directive 200259ec of the european parliament and of the council. Commission directive 2001101ec of 26 november 2001 amending directive 2000ec of the european parliament and of the council on the approximation of the laws of the member states relating to the labelling, presentation and advertising of foodstuffs. Directive 200928ec of the european parliament and of the.
Council directive 200123ec of 12 march 2001 on the. The principle of the common system of vat entails the application to goods and. Through intervention at molecular level, this introduction of new traits by inserting dna pieces, whole genes, long stretches of dna segments from many different. Directive 2001 18 ec provides for the community procedure for granting consent for. Directive 2001 18 ec of the european parliament and of the council of 12 march 2001 on the deliberate release into the environment of genetically modified organisms and repealing council directive 90220eec. The european chemicals agency does not accept any liability with regard.
The environmental risk assessment of gm herbicide tolerant. According to the eu directive 200118ec, a gmo is defined as an. Recovering the original intentions of risk assessment and. A directive is a legal act of the european union which requires member states to achieve a particular result without dictating the means of achieving that result. Commission directive 200561ec of 30 september 2005.
Directive 200118ec of the european parliament and of the council of 12 march 2001 on the deliberate release into the environment of genetically modified. 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. Directive 2001 18 ec of the european parliament and of the council of 12 march 2001 on the deliberate release into the environment of genetically modified organisms and repealing council directive 90220eec commission declaration official journal l 106, 1704 2001 p. This directive establishes the common system of value added tax vat.
Commission regulation ec no 20652001 of 22 october 2001 laying down detailed rules for the application of council regulation ec no 1042000 as regards informing consumers about fishery and aquaculture products 1 created date. It can be distinguished from regulations, which are selfexecuting and do not require any implementing measures. The completion of the internal market must lead to an improvement in the living and working conditions of workers in the european community. Legal analysis of the applicability of directive 200118ec.
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