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Directive 2001/83/ec

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  2. 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 Official Journal L - 311, 28/11/2004, p. 67 - 128 as amended by Directive 2002/98/EC of the European Parliament and of the Council of 27 January 200
  3. 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 EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof
  4. 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. Richtlinie 2001/83/EG des Europäischen Parlaments und des Rates vom 6. November 2001 zur Schaffung eines Gemeinschaftskodexes für Humanarzneimitte
  5. 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 You are here: Directives originating from the E

  1. 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 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
  2. 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 Directiva 2001/83/CE del Parlamento Europeo y del Consejo, de 6 de noviembre de 2001, por la que se establece un código comunitario sobre medicamentos para uso human
  3. 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 DisplayLogo Publications Office of the European Unio
  4. Dieses Dokument ist lediglich eine Dokumentationshilfe, für deren Richtigkeit die Organe der Union keine Gewähr übernehmen B RICHTLINIE 2001/83/EG DES EUROPÄISCHEN PARLAMENTS UND DES RATES vom 6. November 200
  5. Die Richtlinie 2001/83/EG ist eine Richtlinie der Europäischen Union, in der die seit 1965 verabschiedeten Richtlinien, die Humanarzneimittel betreffen, zu einem Gemeinschaftskodex zusammengefasst wurden. Durch eine Reihe von Richtlinien ist in den letzten Jahrzehnten das Arzneimittelrecht in der Europäischen Union weitgehend harmonisiert worden. Als Richtlinie des Europäischen Parlaments und des Rates wirkt die Richtlinie 2001/83/EG mittelbar, indem sie die Mitgliedstaaten der.

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 EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof 2001/83/EC (Consolidated) 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 (Consolidated version : 16/11/2012). Version History. 2012/26/E Directive 2001/83/CE du Parlement européen et du Conseil. du 6 novembre 2001. instituant un code communautaire relatif aux médicaments à usage humain. LE PARLEMENT EUROPÉEN ET LE CONSEIL DE L'UNION EUROPÉENNE, vu le traité instituant la Communauté européenne, et notamment son article 95, vu la proposition de la Commission La présente directive entre en vigueur le 18-12-2001. Modification de la présente directive par le Règlement délégué (UE) n° 1252/2014 de la Commission du 28 mai 2014 complétant la directive 2001/83/CE du Parlement européen et du Conseil en ce qui concerne les principes et lignes directrices de bonnes pratiques de fabrication des substances actives des médicaments à usage humain.

EUR-Lex - 32001L0083 - EN - EUR-Le

  1. 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 2001/83/EC OF THE EUROPEA
  2. lungen festgelegt wurden (1), die darauf abzielt zu ver-hüten, dass Arbeitskräfte oder Patienten übermäßigen oder unnötig hohen ionisierenden Strahlungen aus-gesetzt sind, und insbesondere deren Artikel 5 Buch
  3. 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
  4. F3 Inserted by Directive 2011/62/EU 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)

F3 Inserted by 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) Labelling exemption requests under article 63 of Directive 2001/83/EC examined by QRD group . See also 'Recommendations for the implementation of the exemptions to the labelling and package leaflet obligations in the centralised procedure' document. Labelling exemption requests under article 63 of Directiv e 2001/83/EC examined by QRD group EMA/828662/2017 rev 4 Page 2/26 . Product name. 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 COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Com-munity, Having regard to Directive 2001/83/EC of the Europea An Article 31 pharmacovigilance referral follows the provisions of Article 31 of Directive 2001/83/EC.. It applies where the interests of the Union are involved, and only when the procedure is initiated as a result of the evaluation of data relating to pharmacovigilance of an authorised medicinal product(s) 1.. The procedure for an Article 31 pharmacovigilance referral is laid down in Article.

General. As from 09.02.2019, for medicinal products subject to Directive 2011/62/EC in conjuction with Commission Delegated Regulation (EU) 2016/161 amending Directive 2001/83/EC, a unique identifier (UI) has to be included on the packaging as well as a device allowing verification of whether the packaging has been tampered with (anti-tempering device = ATD) F2 Inserted by Directive 2011/62/EU 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)

Clinical trials conducted outside the EU which are submitted in an application for a marketing authorisation in the EU, must follow the principles equivalent to the provisions of the Clinical Trials Directive (cf. Annex I, point 8 of the Directive 2001/83/EC. Contact points. National competent authorities; Related information. Clinical trial Directive 2001/83/EC of the European Parliament and of the Council Show full title. 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. You are here: Directives originating from the EU; 2001 No. 83; TITLE III ; CHAPTER 1; Article 10 Table of Contents; Content; More Resources; Previous.

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