In particular the gmp requirements provided by title iv of directive 2001 83 ec. Directive 2001 29 ec of the european parliament and of the council of 22 may 2001 on the harmonisation of certain aspects of and related rights in the information society has proven more contentious than its drafters foresaw. 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 200124ec of the european parliament and of the council of 4 april 2001 on the reorganisation and winding up of credit institutions the european parliament and the council of the european union, having regard to the treaty establishing the european community, and in particular article 472 thereof. Hereinafter, the rules made under regulation ec no. Transfers of undertakings directive 2001 wikipedia. 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.
Directive 200427ec of the european parliament and the council of 31 march 2004 amending directive 200183ec on the community code relating to medicinal products for human use official journal l 6, 30042004, p. Mar 21, 2012 directive 2001 14 ec of the european parliament and of the council of 26 february 2001 on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification eu monitor. The proposed directive on copyright in the digital single. The directive took more than two years to negotiate and a central issue was the definition of the family of an eu citizen. 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. 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.
I, mary harney, minister for enterprise, trade and employment, in exercise of the powers conferred on me by section 3 of the european communities act, 1972 no. Directive 2001 14 ec of the european parliament and of the council of 26 february 2001 on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification, official journal l 075 1503 2001. Official journal no page date m1 commission decision 2002623 ec of 24 july 2002 l 200 22 30. This safety data sheet is prepared in accordance with eu directive 91155 ec amended by directive 2001 58 ec europe. Directive 9844 ec of the european parliament and of the council of 6 july 1998 on the legal protection of biotechnological inventions is a european union directive in the field of patent law, made under the internal market provisions of the treaty of rome. Until then, careful use of its flexibility in implementation may prevent the recurrence in europe of some of the problems seen in the us as a result of the dmca. It follows therefrom that, while they are in operation, a credit institution and its. An overview of the general product safety directive 200195ec. This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents b directive 2001 83 ec of the european parliament and of the council. Ec term directive wikisource, the free online library. 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. The revised machinery directive does not introduce radical changes. European community identified the need for a blood.
Tade matthias spranger, faculty of law, rheinische friedrichwilhelmsuniversity bonn october 2015. The annex currently in force is laid down in commission directive 200363 ec of 25 june 2003 amending directive 2001 83 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. Decision of the european parliament of 14 february 2001 and decision of the council of 15 february 2001. This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents 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. However, one aspect of the proposal is problematic, since it will be applicable to situations.
Directive 200014ec noise equipment for use outdoors. The directive 200119ec of the european parliament and of the council of 14 may 2001 controls the general system for the recognition of professional qualifications of nurses responsible for general care, dental practitioners, veterinary surgeons, midwives, architects, pharmacists and doctors in the european union the directive 200119ec amends council directives 8948 ec and 9251 ec. For the purpose of directive 2000ec and in particular articles, 14, 16 and 17. Directive 200183ec of the european parliament and of the.
Decision of the european parliament of 15 may 2001 and decision of the council of 14. Directive 2001 14 ec of the european parliament and of the council of 26 february 2001 on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification, official journal l 075 1503 2001 p. M9 commission directive 2009120 ec of 14 september 2009 l 242 3 15. Directive 200114ec of the european parliament and of the. The first draft of the proposed directive from the ec was issued on 14 september. M2 directive 200070 ec of the european parliament and of the council of 16 november 2000 l 3 22. Legal analysis of the applicability of directive 200118ec. This document is meant purely as a documentation tool and the. Pdf directive 200214ec informationa and consultation. Legal analysis of the applicability of directive 200118. Objectivethe directive aims at ensuring that products placed on the market are safe. Further measures may abolish any remaining barriers to the free movement of proprietary medicinal products will be necessary in the light of.
The current version of the gpsd came into force 15th january 2004. Directive 2001 84 ec of the european parliament and of the council of 27 september 2001 on. This directive represents an important step towards achievement of the objective of the free movement of medicinal products. Official journal no page date m1 directive 201463eu of the european parliament and of the council of 15 may 2014 l 164 1 3. Commission directive 2001101ec amending directive 2000.
Download mdr free mdr gap analysis mddmdr resources. Directive 2001 14 ec of the european parliament and of the council of 26 february 2001 on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification official journal l 075, 1503 2001 p. 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. Shortfalls of the ec clinical trial directive 2001 the eu clinical trial directive, 2001 20 ec, through lack of implementation of trial directives uniformly amongst member states and inattentive operating procedures, has caused business deceleration in clinical research in the eu member states. Directive as amended by directive 2001 12 ec of the european parliament and of the council see page 1 of this official journal. Directive 200214ec of the european parliament and of the council of 11 march 2002 establishing a general framework for informing and consulting employees in the european community. Pursuant to article 11 1 of the proposed directive member states shall provide publishers of press publications with the rights provided for in article 2 and article 32 of directive 200129ec for the digital use of their press publications. Directive on the legal protection of biotechnological. This document is meant purely as a documentation tool and. Consequently, in 2001, the european commission proposed replacing the various laws covering workers, students, etc. Commission directive 200122ec of 8 march 2001 laying.
B council directive 2001110ec of 20 december 2001 relating. The directive on copyright in the digital single market, formally the directive eu 2019790 of. The following is a thematic list of european union directives. The european commission publishes on the internet overviews of dangerous products and the measures taken to eliminate the risks. Directive 2001 14 ec has the right to request a new safety certificate issued in accordance with this regulation and directive 200449 ec from the national safety authority. This directive shall be without prejudice to the specific information and consultation procedures set out in article 2 of directive 9859 ec and article 7 of directive 2001 23 ec. Directive 200427 ec of the european parliament and the council of 31 march 2004 amending directive 2001 83 ec on the community code relating to medicinal products for human use official journal l 6, 30042004, p.
Feb 10, 2020 likewise, in contractual practice performers do not usually transfer or assign to phonogram producers their rights to claim a single equitable remuneration for broadcasting and communication to the public under article 82 of directive 2006115 ec and to fair compensation for reproductions for private use under point b of article 52 of. An overview of the general product safety directive 2001 95 ec. Regulation eu 2017745 of the european parliament and of the council of 5 april 2017 on medical devices, amending directive 200183ec, regulation ec no 1782002 and regulation ec no 12232009 and repealing. Article 2 of the mentioned infosocdirective 200129ec. Directive 200124ec of the european parliament and of the.
Directive 200110ec of the european parliament and of the. Legal analysis of the applicability of directive 2001 18 ec on genome editing technologies commissioned by the german federal agency for nature conservation and prepared by professor dr. Directive 200184ec of the european parliament and of the council of 27 september 2001 on the resale right for the benefit of the author of an original work of art 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. Directive 200195 ec product safety safety and health at. Directive as amended by directive 2001 29 ec of the european parliament and of the council oj l 167, 22. All books are in clear copy here, and all files are secure so dont worry about it. Evaluating directive 200129ec universiteit van amsterdam. Article 7 this regulation shall enter into force on the day following its publication in the official journal of the european union. Assessing the european commissions proposal to revise the. Landfill directive council directive 1999 31 ec of 26 april 1999 on the landfill of waste. All references to the disease in the provisions of such directive shall be deleted accordingly. This text does not contain the annex to directive 200183ec. Directive 201234eu establishing a single european railway area. Clinical trial results posted by sponsors in the eudract, in line with the guideline 2012c30203, are available to the public, since 21 july 2014.
Directive 200195 ec product safety safety and health. Directive as last amended by commission directive 9735 ec oj l 169, 27. Evaluating directive 200129ec in the light of the digital public domain. Definitionsdefinition of terms equipment for use outdoors, conformity assessment procedures, marking, sound power. Mar 29, 2019 with directive 2001 29 ec well into its second decade of life on the law books and a raft of digital single market legislation in the offing, the revised chapter on the directive explores in particular the european court of justices responses to an endless flow of references for preliminary rulings from national courts of the eu. L19426 en officialjournaloftheeuropeancommunities 18. Transfers of undertakings directive 2001 23 ec council directive 77187eec of 14 february 1977 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 businesses. This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents b directive 200183 ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use. L10710 en officialjournaloftheeuropeancommunities 18.
L 77 14 en official journal of the european communities 16. 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 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. It was intended to harmonise the laws of member states regarding the patentability of biotechnological inventions, including. Water framework directive directive 2000 60 ec of the european parliament and of the council of 23 october 2000 establishing a framework for community action in the field of water policy. Download directive 2001 95 ec of the european parliament and of the.
The european commission is due to report on the operation of the directive in december 2004, after which amendments may be made by the parliament and council. Transfers of undertakings directive 200123ec council directive 77187eec of 14 february 1977 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 businesses. Council directive 200123ec of 12 march 2001 on the. B council directive 2001110ec of 20 december 2001 relating to honey oj l 10, 12. Directive 2001 14 ec of the european parliament and of the council of 26 february 2001 on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification. Procurement laws privatization laws anticorruption freedom of. Definitionsdefinition of terms equipment for use outdoors, conformity assessment procedures, marking, sound power level lwa. 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. Directive 201234eu of the european parliament and of the council of 21. Directive 2001 83 ec of the european parliament and of the council show full title. Full text english website references legislation amends. The transfers of undertakings directive 2001 23 ec is a european union law that protects the contracts of employment of people working in businesses that are transferred between owners. The clinical trials directive officially directive 2001 20 ec of 4 april 2001, of the european parliament and of the council on the approximation of the laws, regulations and administrative provisions of the member states relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use is a european union directive.
Eu directive 200114 set out the framework for the construction of bodies that control and regulate the allocation of line possessions to companies, and the charges for using the track, this directive replaced the previous legislation eu directive 9519. It replaced and updated the law previously known as the acquired rights directive 77187 ec. M3 commission directive 2009106 ec of 14 august 2009 l 212 42 15. B directive 2001 20 ec of the european parliament and of the council of 4 april 2001. 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. Directive 200114ec of the european parliament and of the council of 26 february 2001 on the allocation of railway infrastructure capacity and the levying of. This text does not contain the annex to directive 2001 83 ec. Objectivethe objective of this directive is to improve the control of noise emission in the environment by equipment for use outdoors.
Legislative discussions during the adoption of directive 2001 18 ec 30. Directive 200114ec of the european parliament and of. Commission directive 200127ec adapting to technical. Guidance on investigational medicinal products imps and. Directive on copyright in the digital single market wikipedia. Council directive 200043ec of 29 june 2000 implementing the principle of equal treatment between persons irrespective of racial. 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. M1 commission directive 2001 101 ec of 26 november 2001 l 310 19 28. Directive 200184ec of the european parliament and of the. B directive 200183 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.
Article 1 paragraph 1 the purpose of this directive is to ensure that products placed on the market are safe. Read online directive 2001 95 ec of the european parliament and of the. Commission directive 200122ec of 8 march 2001 laying down. 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. Apr 20, 2001 directive 200117ec insurance windingup directive.
It contributes to the smooth functioning of the internal market, while protecting human health and wellbeing. 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. This directive shall be without prejudice to provisions adopted in accordance with directives 9445 ec and 9774 ec. This is outlined in european commission guideline, in application of the current clinical trials directive 2001 20 ec and the paediatric regulation.