It replaced and updated the law previously known as the acquired rights directive 77187ec. Directive 200184ec of the european parliament and of the. Directive 200114ec of the european parliament and of the. Decision 2001 497 ec, it is appropriate that the commission evaluates them three years after their notification to the member states 12 decision 2001 497 ec should be amended accordingly.
This is outlined in european commission guideline, in application of the current clinical trials directive 200120ec and the paediatric regulation. Article 1 paragraph 1 the purpose of this directive is to ensure that products placed on the market are safe. By means of the repeated inspections referred to in article 1111a of directive 200183ec, the member states shall ensure that manufacturers authorised in accordance with article 401 and 3 of directive 200183ec respect the principles and guidelines of good manufacturing practice laid. Directive 200124ec of the european parliament and of the. It was adopted by the european parliament 02 april 2014 and. 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.
L 7714 en official journal of the european communities 16. This document is meant purely as a documentation tool and. The rules on crossborder mergers represent a significant milestone in improving the. 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. 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 notice to applicants, volume 2a procedures for marketing authorisation, chapter 3 union referral procedures dated may 2014 2. Commission directive 200122ec of 8 march 2001 laying. Directive 200857ec of the european parliament and of the. Directive 949ec of the european parliament and the council of 23 march 1994 author. This directive shall be without prejudice to provisions adopted in accordance with directives 9445 ec and 9774 ec. By means of the repeated inspections referred to in article 1111a of directive 2001 83 ec, the member states shall ensure that manufacturers authorised in accordance with article 401 and 3 of directive 2001 83 ec respect the principles and guidelines of good manufacturing practice laid down by this directive. Council directive 200123ec on the safeguarding of employees rights in the event. Commission report on council directive 200123ec of 12 march.
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. Level crossing with crossinguserside manual protection andor warning. The purpose of this directive is to promote an increase in the contribution of renewable energy sources to electricity production in the internal market for electricity and to create a basis for a future community framework thereof. Renewable enregy sources are defined as renewable nonfossil energy sources, i. Directive 949ec of the european parliament and the. 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. Directive 200514ec of the european parliament and of the council of 11 may 2005 amending council directives 72166eec, 845eec, 88357eec and 90232eec and directive 200026ec of the european parliament and of the council relating to insurance against civil liability in respect of the use of motor vehicles eu monitor. L19426 en officialjournaloftheeuropeancommunities 18. Commission directive 2006ec of 3 february 2006 amending. Directive 200928 ec of the european parliament and of the council on the promotion of the use of energy from renewable sources and amending and subsequently repealing directives 2001 77 ec and 200330 ec.
Official journal no page date m1 council directive 200484ec of 10 june 2004 l 219 8 19. 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 90220 eec oj l 106, 17. Shifts in clinical trial application rates over time indicate if the attractiveness of a country or region for the conduct of clinical trials is growing or decreasing. Commission report on council directive 200123ec of 12. Basically the proposal, like directive 2001 95 ec on general product safety, demands of economic operators in art.
Pdf directive 200214ec informationa and consultation. The action levels should therefore be transferred from recommendation 2002201 ec to annex ii to directive 200232 ec. A general overview is provided by francescon, the new directive 200118ec on the deliberate release of genetically modified organisms into the environment. Directive 200110ec of the european parliament and of the. B council directive 20011ec of 20 december 2001 relating.
Experiences from the implementation of the crossborder. B 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 oj l 121, 1. Guidelines for the application of directive 200014ec of. An overview of the general product safety directive 200195ec. Directive 2015eu of the european parliament and of the council of 5 april 2011. Transfers of undertakings directive 2001 wikipedia. The action levels should therefore be transferred from recommendation 2002201ec to annex ii to directive 200232ec. M1 commission directive 2001101ec of 26 november 2001 l 310 19 28. Directives 9256eec and 9859ec, requires employers to enter into negotiations with workers in the event of mass redundancy, with a view to identifying ways of avoiding collective redundancies or reducing the number of workers affected. Legal analysis of the applicability of directive 200118. On 14 may 2018, the commission published a refit evaluation of the european. 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,6 and council directive 9445ec of 22 september 19947 and council directive 9774ec8 of 15 december 1997, both of which concern the establishment of a european.
Decision 2001497ec, it is appropriate that the commission evaluates them three years after their notification to the member states 12 decision 2001497ec should be amended accordingly. 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. Section ii of annex b to directive 9168eec mentioning scrapie is hereby deleted. Full text english website references legislation amends. Directive 201162eu of the european parliament and of the. L10710 en officialjournaloftheeuropeancommunities 18. Impact assessment of the european clinical trials directive. It is presumed that a product meets this safety requirement under art. The purpose of this observational study was to track changes in drug trial application patterns across several eu countries in order to analyze the mediumterm impact of the eu clinical trials directive 2001 20 ec on the conduct. B council directive 20011ec of 20 december 2001 relating to fruit jams, jellies and marmalades and sweetened chestnut puree intended for human consumption oj l 10, 12.
Directive 2001 37 ec of the european parliament and of the council of 5 june 2001 on the approximation of the laws, regulations and administrative provisions of the member states concerning the manufacture, presentation and sale of tobacco products. Commission directive 200122ec of 8 march 2001 laying down. 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. France completes implementation of crossborder mergers. Equipment and protective systems intended for use in potentially explosi ve atmospheres keywords. The current version of the gpsd came into force 15th january 2004. 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 new eu clinical trials regulation 4 regulation of the european parliament and of the council on clinical trials on medicinal products for human use, repealing directive 200120ec the new regulation directly applies to all individuals in the european union. Directive 20034ec of the european parliament and of the.
Legal analysis of the applicability of directive 200118ec. The transfers of undertakings directive 200123ec is a european union law that protects the contracts of employment of people working in businesses that are transferred between owners. Council directive 200123ec 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, 22032001 p. A number of these have been revised and updated to bring them in line with the changes and requirements of the clinical trials regulation. The new european product safety and market surveillance. The european union, having regard to the treaty establishing the european. France completes implementation of crossborder mergers directive. 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 charges for the use of railway infrastructure and safety certification official journal l 075, 15032001 p. Clinical trials directive 2001 20 ec guidelinesguidelines and recommendations on the application of the clinical trials directive are published in eudralex volume 10. Hereinafter, the rules made under regulation ec no. It replaced and updated the law previously known as the acquired rights directive 77187 ec. The clinical trials directive officially directive 200120ec 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 that aimed at.
Directive 200177ec of the european parliament and of the. Apr 27, 2017 not to be overlooked, it argues, is the fact that under article 51 of directive 200114ec, railway undertakings are entitled to what is called the minimum access package and track access to service facilities that are described in annex ii to the directive, point 2h of which refers to maintenance and other technical facilities. European highspeed rail system3 and directive 200116ec of the european. Council directive 200123ec of 12 march 2001 on the.
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 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. Basically the proposal, like directive 200195ec on general product safety, demands of economic operators in art. 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 procedures dated may 2014 2. Workers right to information, consultation and participation.
M1 commission directive 2001 101 ec of 26 november 2001 l 310 19 28. This document is meant purely as a documentation tool and the. European commission, press release, november 18, 2003, memo03233. Without prejudice to the rules governing the collective exercise of their rights, article. 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. Directive 2000 14 ec of the european parliament and of the council of 8 may 2000 on the approximation of the laws of the member states relating to the noise emission in the environment by equipment for use outdoors 1 the outdoor noise directive, ond, throughout the single internal. To increase efficiency, two or more member states may decide to merge the. The new eu clinical trials regulation 4 regulation of the european parliament and of the council on clinical trials on medicinal products for human use, repealing directive 2001 20 ec the new regulation directly applies to all individuals in the european union. Towards a 14th company law directive cci paris idf. In which situations is an urgent union procedure initiated.
Directive 200514ec of the european parliament and of the. Not to be overlooked, it argues, is the fact that under article 51 of directive 200114ec, railway undertakings are entitled to what is called the minimum access package and track access to service facilities that are described in annex ii to the directive, point 2h of which refers to maintenance and other technical facilities. 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 charges for the use of railway infrastructure and safety certification eu monitor. It follows therefrom that, while they are in operation, a credit institution and its. All references to the disease in the provisions of such directive shall be deleted accordingly. Norway, iceland and liechtenstein article 68 of the agreement on the european. 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 charges for the use of railway infrastructure and safety certification, official journal l 075 15032001 p. Commission directive 2001 59 ec of 6 august 2001 adapting to technical progress for the 28th time council directive 67548 eec on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances text with eea relevance the commission of the european communities. 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 that aimed at. 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. Official journal no page date m1 commission decision 2002623 ec of 24 july 2002 l 200 22 30. Directive 20034ec of the european parliament and of the council of 28 january 2003 on public access to environmental information and repealing council directive 903eec official journal l 041, 14022003 p. 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.
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