Council directive 9883ec of 3 november 1998 on the quality of water intended for human consumption council directive 9883ec european environment agency. Ano 2015 5185 5939 1260 38 46 112 82 83 80 12 33 12870 janeiro 111 737 2 2 4 8 2 866 fevereiro 496 527 31 2 9 30 14 4 11. Council directive 200123ec of 12 march 2001 on the. This text does not contain the annex to directive 200183 ec. Directive 200124ec of the european parliament and of the. 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 200180ec, large combustion plants european. Assessment report pursuant to article 30 of directive 2001. 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. 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. Public assessment report of the medicines evaluation. According to directive 200424ec which amended the basic legislation laid down in directive 200183ec a new european legislation on herbal medicinal products was developed, in order to.
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. 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. 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. Background information on the basis of the grounds for referral. 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. Directive 2001 83 ec of the european parliament and of the council show full title. Definition of directive 200181ec in the legal dictionary by free online english dictionary and encyclopedia. Directive 200120ec of the european parliament and of the.
Directive as amended by directive 200064 ec of the european parliament and of the council. 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. Assessment report pursuant to article 30 of directive 200183ec, as amended ema2674482012 page 320. 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 falsified medicinal products.
Glossary european database of suspected adverse drug. 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. Directive as last amended by directive 200212 ec of the european parliament and of the council oj l 77,20. M1 commission directive 2001101ec of 26 november 2001 l 310 19 28. Directive 200184ec of the european parliament and of the. Article 1 paragraph 1 the purpose of this directive is to ensure that products placed on the market are safe. The mr and dc procedures have to be used for the products that are being authorised in the eueea.
Directive 200181ec legal definition of directive 200181ec. Article 65 of directive 200183ec as amended by directive 200427ec. 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. Article 1 of directive 200183ec as amended defines an adverse drug reaction as a response to a medicinal product which is noxious and unintended. 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. 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 200183ec article 17 or as a fasttrack procedure, unless justified. Amended by 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 oj l 159, 27. 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. Council directive 9883ec european environment agency. 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.
Space shall be provided for the prescribed dose to. 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 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. 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. Official journal no page date m1 directive 200298ec of the european parliament and of the council of 27 january 2003 l 33 30 8. The european commission informs the national contact points of. It was adopted by the european parliament 02 april 2014 and. 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. Eu directive 200183 areas to be addressed are covered by eu provisions i. Directive 200195 ec product safety safety and health.
L10710 en officialjournaloftheeuropeancommunities 18. 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. This document is meant purely as a documentation tool and. Directive 2001 83 ec of the european parliament and of the. Directive 200196ec directive 199834ec directive 199770ec related videos. Directive 200183ec of the european parliament and of the council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use, oj l 337, 25. Each application, whether authorised nationally or through mutual recognition, must be accompanied by the eu application form in order for it to be validated. Directive 200181ec article about directive 200181ec. In the period 20042015, lcps were covered by directive 200180ec, while in 2016 lcps were subject to reporting in accordance with directive 201075eu. Directive 201162eu of the european parliament and of the. Guide to renewal of marketing authorisations human medicines.
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 l311 20011128 20081231 32006l0040 eu 27 directive 200640ec of the european parliament and of the council of 17 may 2006 relating to emissions from air. If the condition is a non interventional pass, it will be subject to the supervision set out in art 107 mq of directive 200183ec and the format and content of such non interventional pass as described in implementing regulation 5262012 annex iii see gvp module viii. New medical devices regulation and ivd regulation text. 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. On 31 august, 2010 the european commission presented to the e uropean medicines agency a referral. Pagina data m1 directiva 200298ce a parlamentului european. Directive 200183ec, article 10a for product information for healthcare professionals and users, including information on pack sizes and presentations, see summary of product characteristics spc, package leaflet and labelling. Directive 200183ec should be amended in order to respond to this increasing threat.
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. Note the packaging of medicinal products placed on the market and incorporating tamper verification features in accordance with this international standard meets, as an example but not limited to, the requirements of directive 200183ec 1 as amended by directive 201162eu. An overview of the general product safety directive 200195ec. 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. The scope of this latter directive is slightly wider and thus covers plants that were not subject to reporting before 2015. Directive 200183ec of the european parliament and of the. However, if the product is an injectable, or a topical or eye preparation, all excipients must be stated. 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 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. Commission directive 200394ec the commission of the. 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 use 1, as last amended by commission directive 200363ec 2, and in particular article 47 thereof, whereas.