This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents b council directive 2001 112 ec of 20 december 2001 relating to fruit juices and certain similar products intended for human consumption oj l 10, 12. 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. In accordance with article 54o of directive 200183ec and article 322 of commission delegated regulation eu 2016161, an antitampering device has to allow. This text does not contain the annex to directive 200182ec. 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. 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. Directive 200180ec, large combustion plants european. 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.
Directive 2001 83 ec of the european parliament and of the council of 6 november 2001. An overview of the general product safety directive 200195ec. The right to information is of crucial importance for the enduser of pharmaceuticals to exercise their right of selfdetermination. Article 49 of eu directive 2001 83 ec as amended specifies qp education requirements how eu member states have incorporated these requirements has varied between member states way of incorporation of qp role in national law the way of naming the qp and delegation of the activities also varies between member states. This document is meant purely as a documentation tool and the. Apr 28, 2017 unlike the proposed directive on, in particular conformity of goods, that only covers online trade,1 the consumer rights directive 2011 83 ec covers both business with consumers on premises and at a distance, including online. Free movement of goods articles 28 ec and 30 ec articles 11 and of the eea agreement imported medicinal products not authorised in the importing state prohibition of advertising directive 200183ec in case c.
The mr and dc procedures have to be used for the products that are being authorised in the eueea. Directive 200183ec of the european parliament and of the council of 6 november. In the interests of clarity and rationality, the said directives should therefore be codified by assembling them in a single text. 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 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. Download directive 200183ec of the european parliament and of the. Directive 200954 ec of the european parliament and of the council7 and directive 2001 83 ec of the european parliament and of the council8. 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. This text does not contain the annex to directive 200183ec. In case where starting and raw materials, active substances or excipients are described neither in the european pharmacopoeia nor in the pharmacopoeia of a member state, compliance with the monograph of a third country pharmacopoeia can be accepted. The procedure for certification of suitability to the. Commission directive 200394ec the commission of the. No 230993, directive 2001 82 ec of the european parliament and of the council and as defined in directive 2001 83 ec of the european parliament and of the council.
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. It requests the respective applicants to provide the pharmacopoeia with respective data. Directive 200183ec as amended requests licensing authorities to provide the pharmacopoeia with information on the need for additional tests to control the quality of a substance. 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. According to article 10b of directive 200183ec, relating to applications for new fixed combination of active substances in a medicinal product according to article 10c of directive 200183ec, relating to informed consent from a mah for an authorized medicinal product. Read online directive 200183ec of the european parliament and of the. The current version of the gpsd came into force 15th january 2004. Article 1 paragraph 1 the purpose of this directive is to ensure that products placed on the market are safe. State concerned in accordance with directive 200183ec of the. L10710 en officialjournaloftheeuropeancommunities 18. Directive 200184ec of the european parliament and of the. Are there any mandatory specifications for the antitampering device. Directive 200183ec replacing old directives the core legislation governing the regulation of drugs in eu, provides the framework for regulation of medicines at national level regulation ec no 7262004 replacing ec no 230993 sets out the centralised procedure 3.
The british pharmacopoeia m vallender acting group. 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. B council directive 2001112ec of 20 december 2001 relating. Regulation ec no 942007 of the european parliament and of the council of november 2007 on advanced therapy medicinal products and amending directive 2001 83 ec and regulation ec no 7262004 oj l 324, 10. During the covid19 pandemic, member states may therefore accept that the. Directive 200953 ec of the european parliament and of the council of 18 june 2009 amending directive 2001 82 ec and directive 2001 83 ec, as regards variations to the terms of marketing authorisations for medicinal products oj l 168, 30. In the directive 2001 83 ec relating to pharmaceuticals for human use all the particulars that have to be on the labelling or in the package leaflet are stipulated and need to be transposed into national law.
In the directive 200183ec relating to pharmaceuticals for human use all. Applications according to article 83 of directive 200183ec. Pharmaceutical regulations in european union sciencedirect. The european system for medicinal products the george institute. Legislation on the preparation of medicinal products in european. Pdf transposition measures of member states in relation to the. Jan 19, 2018 it is to be stressed that this procedure should in no way be considered as an easy way of circumventing the current procedures stipulated by the eu legislation directive 2001 83 ec article 17 or as a fasttrack procedure, unless justified. All books are in clear copy here, and all files are secure so dont worry about it. In the eu, medicinal products are regulated by directive 200183ec and regulation ec no 7262004. 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 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. 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.
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. 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. 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. Chapter 1 marketing authorisation european commission. 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. Council directive 200123ec of 12 march 2001 on the. In which situations is an urgent union procedure initiated. Directive 200183ec of the european parliament and of the. Directive 2001 83 ec of the european parliament and of the council show full title. This document is meant purely as a documentation tool and. This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents b directive 2000 ec of the european parliament and of the council. New chemical entities approved on the basis of a complete, freestanding data.
In 2017 a new regulation eu 2017745 of the european parliament and of the council of 5 april 2017 on medical devices has been published in the official journal of the european union on 5 may 2017, amending directive 2001 83 ec, regulation ec no 1782002 and regulation ec no 12232009 and repealing council directives 90385eec and 9342eec. Pdf global attention to the danger of falsified medicinal products is gaining momentum. Under article 633 of directive 2001 83 ec member states may grant full or partial exemptions to certain labelling and packaging requirements to address severe problems in respect of the availability of medicinal products. Commission directive 200127ec adapting to technical. 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. This text does not contain the annex to directive 2001 83 ec. Read online directive 2001 83 ec of the european parliament and of the. Directive 200180ec 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. 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. Directive 200183ec replacing old directives the core legislation governing the. References throughout the notice to applicants to provisions of directive 2001 83 ec and regulation ec 7262004 must be read as references to the directive and the regulation as last amended3, unless it is otherwise expressly stated.
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