Directive 200120ec as well as regulation ec no 7262004 and directive 200183ec, an adverse reaction to an imp or nonimp occurring in a clinical trial is only to be reported or followed up in accordance with directive 200120ec. 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. Member states shall bring into force the laws, regulations and administrative provisions necessary to comply with this directive by 31 december 2001 at the latest. Equipment and protective systems intended for use in potentially explosi ve atmospheres keywords. European commission brussels, xxx com2012 3722 20120180 cod proposal for a directive of the european parliament and of the council on collective management of and related rights and multiterritorial licensing of rights in musical works for online uses in the internal market text with eea relevance swd2012 204. Directive 200184ec of the european parliament and of the council. 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. Directive 200197ec of the european parliament and of the council of 4 december 2001 amending council directive 98eec on prevention of the use of. Council directive 6565eec of 26 january 1965 on the approximation of provisions laid.
Directive 200182ec of the european parliament and of the. Commission directive 200122ec of 8 march 2001 laying down the sampling methods and the methods of analysis for the official control of the levels of lead, cadmium, mercury and 3mcpd in foodstuffs text with eea relevance. Directive 949ec of the european parliament and the council of 23 march 1994 author. 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.
Communication from the commission detailed guidance on the. 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, having regard to the proposal from the commission1. In applying that directive, this detailed guidance should be complied with. 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 84 ec 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. 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. Objectivethe directive aims at ensuring that products placed on the market are safe.
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. This report outlines the consideration of the proposal for a directive of the european parliament and of the council discontinuing seasonal changes of time and repealing directive 200084ec. Legal analysis of the applicability of directive 200118ec on genome editing technologies commissioned by the german federal agency for nature conservation and prepared by professor dr. Directive 2000 84 ec of the european parliament and of the council of 19 january 2001 on summertime arrangements. Legal analysis of the applicability of directive 200118ec. 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. 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. An interdepartmental steering group was established in september 2018, chaired by the. For greater accessibility, the provisions of the annexes to directives 200648ec and 200649ec should be integrated into the enacting terms of this directive and of that regulation. Directive 200177ec 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.
Directive 200184ec of the european parliament and of the councilshow full title. Commission directive 2001 22 ec of 8 march 2001 laying down the sampling methods and the methods of analysis for the official control of the levels of lead, cadmium, mercury and 3mcpd in foodstuffs text with eea relevance. This item of legislation is only available to download and view as pdf. Directive 200183ec, regulation ec no 1782002 and regulation ec no 12232009 and a regulation on in vitro diagnostic medical devices the european data protection supervisor, having regard to the treaty on the functioning of the european union, and in particular article 16 thereof. The beneficiaries of this directive should only be permitted to use a work or phonogram one or more of the rightholders in which are not identified or not located, if they are authorised to carry out the acts of reproduction and of making available to the public covered by articles 2 and 3 respectively of directive 200129ec by those. 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. In which situations is an urgent union procedure initiated. The certlficate referred to in paragraph i i i 5 of directive 2001 83 ec and of directive 2001 82 ec, shall also be required for imports coming from third countries into a member state guidance on the interpretation of this template can be found in the help menu of eudragmdp database these requirements fulfil the gmp recommendations of who. This text does not contain the annex to directive 2001 83 ec.
Article 1 paragraph 1 the purpose of this directive is to ensure that products placed on the market are safe. Opinion of the european data protection supervisor on the. This text does not contain the annex to directive 200182ec. 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. The annex currently in force is laid down in commission directive 200363ec of 25 june 2003 amending directive 200183ec 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. 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. 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. Pdf on oct 29, 2018, and others published directive 200184ec. Directive 2010 84 eu of the european parliament and of the council of 15 december 2010 amending, as regards pharmacovigilance, directive 2001 83 ec on the community code relating to medicinal products for human use text with eea relevance the european parliament and the council of the european union. Official journal no page date m1 council directive 200484ec of 10 june 2004 l 219 8 19. 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. This document is meant purely as a documentation tool and. Commission guidelines on good distribution practice of medicinal products for human use legal basis for publishing the guidelines.
Directive 2036eu of the european parliament and of the. Tade matthias spranger, faculty of law, rheinische friedrichwilhelmsuniversity bonn october 2015. Specific implementation measures of the commission in the context of directive 201162 ec amending directive 2001 83 ec on falsified medicines overview article in directive 2001 83 ec type of commission measure topic target date for adoption publication stakeholder consultation, involvement of member statesexperts from member states. B council directive 9342eec of 14 june 1993 concerning medical devices oj l 169, 12. An overview of the general product safety directive 200195ec. 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. 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. 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 is a european union directive in the field of law, made under the internal market provisions of the treaty of rome. The proposed guidelines will replace the guidelines on good distribution practice of medicinal products for. This text does not contain the annex to directive 200183ec. Directive on copyright in the digital single market wikipedia.
The certlficate referred to in paragraph i i i 5 of directive 200183ec and of directive 200182ec, shall also be required for imports coming from third countries into a member state guidance on the interpretation of this template can be found in the help menu of eudragmdp database these requirements fulfil the gmp recommendations of who. Official journal no page date m1 directive 9879ec of the european parliament and of the council of 27 october 1998 l 331 1 7. Directive 200197ec of the european parliament and of the council of 4 december 2001 amending council directive 98eec on prevention of the use of the financial system for the purpose of money laundering. Directive 2001 84 ec of the european parliament and of the council on the resale right for the benefit of the author of an original work of art enforcement directive directive 200448 ec of the european parliament and of the council on the enforcement of intellectual property rights. Directive 200183 ec of the european parliament and of the council. Without prejudice to article 83, member states shall take. B council directive 20011ec of 20 december 2001 relating. Communication from the commission detailed guidance on. 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 council directive 9342eec of 14 june 1993 concerning.
Directive 200110ec of the european parliament and of the council of 22 may 2001 amending council directive 9168eec as regards scrapie. The beneficiaries of this directive should only be permitted to use a work or phonogram one or more of the rightholders in which are not identified or not located, if they are authorised to carry out the acts of reproduction and of making available to the public covered by articles 2 and 3 respectively of directive 2001 29 ec by those. The current version of the gpsd came into force 15th january 2004. Directive 200916ec of the european parliament and of the council of 23 april 2009 on port state control recast ship safety legislation directive 200945ec regulation ec no 3362006 directive 200325ec directive 200196ec directive 199834ec directive 199770ec. Directive 200084ec of the european parliament and of the council of 19 january 2001 on summertime arrangements oj l 31, 2. Directive 949ec of the european parliament and the council. Directive 200184ec of the european parliament and of the council on the resale right for the benefit of the author of an original work of art enforcement directive directive 200448ec of the european parliament and of the council on the enforcement of intellectual property rights. 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. Oeic regulations openended investment companies regulations 2001. An overview of the european artists resale right directive 200184ec and its implementation in the uk via the artists. Directive 200084ec of the european parliament and of the council. April 2012 specific implementation measures of the. Directive 200916 ec of the european parliament and of the council of 23 april 2009 on port state control recast ship safety legislation directive 200945 ec regulation ec no 3362006 directive 200325 ec directive 2001 96 ec directive 199834 ec directive 199770 ec. Article 84 of directive 2001 83 ec on the community code relating to medicinal products for human use.
Council directive 200123ec of 12 march 2001 on the. Acts adopted under the ec treatyeuratom treaty whose publication is obligatory directives commission directive 200884ec of 27 august 2008 laying down specific purity criteria on food additives other than colours and sweeteners text with eea relevance codified version the commission of the european communities. For greater accessibility, the provisions of the annexes to directives 200648 ec and 200649 ec should be integrated into the enacting terms of this directive and of that regulation. Directive 201084eu of the european parliament and of the council of 15 december 2010 amending, as regards pharmacovigilance, directive 200183ec on the community code relating to medicinal products for human use text with eea relevance the european parliament and the council of the european union. 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. Those national laboratories are listed in that directive. Directive 2001 84 ec 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 is a european union directive in the field of law, made under the internal market provisions of the treaty of rome. 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.
In 2017, human rights watch and reporters without borders were among the signatories of an open letter opposing article. Directive 200184ec of the european parliament and of the. Regulation ec no 12232009 of the european parliament and of the council 2. Unions eu pharmacovigilance framework established by directive 200183ec the. The following point shall be inserted after point 68b eighth directive 9744ec of the european parliament and of the council of annex xiii to the agreement. Directive 200183ec of the european parliament and of the council. 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. This document is meant purely as a documentation tool and the. Specific implementation measures of the commission in the context of directive 201162ec amending directive 200183ec on falsified medicines overview article in directive 200183ec type of commission measure topic target date for adoption publication stakeholder consultation, involvement of member statesexperts from member states. Directive as last amended by directive 9526 ec oj l 168, 18. Directive 200120ec of the european parliament and of the. Directive 201084ec the european parliament and the council of the. Report of the interdepartmental group on eu proposal to.
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