L10710 en officialjournaloftheeuropeancommunities 18. Directive 201084eu 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. In the period 20042015, lcps were covered by directive 2001 80 ec, while in 2016 lcps were subject to reporting in accordance with directive 201075eu. Labelling exemption requests under article 63 of directive. Pdf study on the transposition measures of member states. 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.
The european system for medicinal products the george institute. This document is meant purely as a documentation tool and. In the directive 200183ec 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. Directive 201084eu of the european parliament and of the.
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. 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. F1 substituted by 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 text with eea relevance. 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. The scope of this latter directive is slightly wider and thus covers plants that were not subject to reporting before 2015. 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. Directive 200183ec of the european parliament and of the council show full title. 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 200183ec, regulation ec no 1782002 and regulation ec no 12232009 and repealing council directives 90385eec and 9342eec. All books are in clear copy here, and all files are secure so dont worry about it. Directive 2001 83 ec is related to the community code relating to medicinal products for human use.
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 201226eu of the european parliament and of. B council directive 2001110ec of 20 december 2001 relating to honey oj l 10, 12. Read online directive 200183ec of the european parliament and of the. Articles 83 85 of directive 2001 82 ec to suspend or revoke such authorisation. Directive 2001 81 ec, on nation al emissions ceilings necd for certain atmospheric pollutants. F2 inserted by directive 201162eu of the european parliament and of the council of 8 june 2011 amending directive 2001 83 ec on the community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products text with eea relevance. Labelling exemption requests under article 63 of directive 200183ec examined by qrd group. F2 inserted by directive 201162eu of the european parliament and of the council of 8 june 2011 amending directive 200183ec on the community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of. Directive 200183ec of the european parliament and of the council. Commission directive 200394ec the commission of the. Delegations will find in the annex to this document a consolidated text for the articles of the proposed regulation mentioned above prepared by the latvian presidency with a view to the meeting of the council epsco on 19 june 2015. 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 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.
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 council directives 90385eec and 9342eec text with eea relevance. 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 200183ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal products for human use. 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 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. 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. Directive 200183ec is related to the community code relating to medicinal products for human use. 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. Article 1 paragraph 1 the purpose of this directive is to ensure that products placed on the market are safe. 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.
See also recommendations for the implementation of the exemptions to the labelling and package leaflet obligations in the centralised procedure document. This text does not contain the annex to directive 200183 ec. 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. Scribd is the worlds largest social reading and publishing site. B council directive 2001 110 ec of 20 december 2001 relating to honey oj l 10, 12. Directive 200183ec should be amended in order to respond to this increasing threat. Directive 200528ec, defines good clinical practice for design and conduct of clinical trials. The directive dealt with the disparities between certain nationalprovisions, in particular between provisions relating to medicinal products, which directly affected the functioning of the internal market of the european union. The mr and dc procedures have to be used for the products that are being authorised in the eueea. Commission directive 2001101ec amending directive 2000. 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. 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. The directive deals with the differences between certain national requirements, in particular between requirements relating to medicinal products, which directly affect the functioning of the internal market of the eu.
State concerned in accordance with directive 200183ec of the. 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 200183ec of the european parliament and of the council of 6 november 2001 on the community code relating to medicinal. Directive 200183ec of the european parliament and of the. Directive 200181ec, national emission ceilings european. Having regard to 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 use1, as last amended by commission directive 200363 ec 2, and in particular article 47 thereof. The right to information is of crucial importance for the enduser of pharmaceuticals to exercise their right of selfdetermination. 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. Official journal no page date m1 directive 200298ec of the european parliament and of the council of 27 january 2003 l 33 30 8. In the period 20042015, lcps were covered by directive 200180ec, while in 2016 lcps were subject to reporting in accordance with directive 201075eu. Directive 200181ec, on nation al emissions ceilings necd for certain atmospheric pollutants. 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.
Directive 2001 83 ec should be amended in order to respond to this increasing threat. Official journal no page date m1 directive 201463eu of the european parliament and of the council of 15 may 2014 l 164 1 3. B council directive 2001110ec of 20 december 2001 relating. An overview of the general product safety directive 200195ec. Regulation eu 2017745 of the european parliament and of. Pagina data m1 directiva 200298ce a parlamentului european. Application form for the withdrawal of a marketing authorisation, an authorisation in accordance with article 126a of directive 2001 83 ec or a parallel import licence application received on. Application form for the withdrawal of a marketing. Download directive 200183ec of the european parliament and of the. 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 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 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 200120ec, defines rules for the conduct of clinical trials. Directive 9341eec, establishes the european agency for the evaluation of medicinal products. En en directive 200298ec of the european parliament and of the council of 27 january 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending directive 200183ec,18 7.
The current version of the gpsd came into force 15th january 2004. The directive dealt with the disparities between certain national provisions, in particular between provisions relating to medicinal products, which directly affected. The annex currently in force is laid down in commission directive 200363ec 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. 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. Council directive 200123ec of 12 march 2001 on the. Article 49 of eu directive 200183ec 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. European parliament and of the council or under regulation. Application form for the withdrawal of a marketing authorisation, an authorisation in accordance with article 126a of directive 200183ec or a parallel import licence. Directive 200182ec of the european parliament and of the council of 6 november 2001 on the community code relating to veterinary medicinal products official journal l 311, 28112004, p. The directive deals with the differences between certain national requirements, in particular between requirements relating to medicinal products, which directly affect the functioning of. Directive 200184ec of the european parliament and of the. 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.
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