directive 2001 83 ec consolidated

directive 2001

Directive 2004/27/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 – 136 30/04/2004 p 34 – 57 This text does not contain the Annex to Directive 2001/83/EC The Annex currently in force DA: 49 PA: 6 MOZ Rank: 31

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The EU Food Supplement Regime

: Manufacturers of products that can be marketed within the dietary supplements regime in the United States seeking to sell them in the EU should be aware that regulation of such products in Europe is becoming increasingly demanding and may pose some unfamiliar challenges

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The need for transparency of clinical evidence for medical

To use medical devices rationally health-care professionals must base their choices of which devices to recommend for individual patients on an objective appraisal of their safety and clinical efficacy The evidence submitted by manufacturers when seeking approval of their high-risk devices must be publicly available including technical performance and premarket clinical studies

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DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF

Directive 2002/98/EC 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 2001/83/EC Official Journal L – 33 08/02/2003 p 30 – 40 Directive 2004/24/EC of the European Parliament and the Council of 31 March 2004

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Amendment 58 ALDE

Consolidated amendment replacing Amendments 1146 to 1248 JURI 65 IMCO 59 INTA 55 AGRI 69 ITRE 65 Proposal for a directive Article 18 Text proposed by the Commission Amendment 1 Nicotine-containing products may only be placed on the market in accordance with the provisions for tobacco products as laid out in articles 5 17 20

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Надлежащая производственная практика Function owners

The concept of advertising is defined in Article 86 of the consolidated Directive 2001/83/EC (see figure 2 D-14) Figure 2 D-14 Advertising for the purposes of Directive 2001/83/EC Advertising for the purposes of Article 86 Directive 2001/83/EC

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Directive 2001/83/EC — Wikipedia Republished // WIKI 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 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

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directive 2001

Directive 2004/27/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 – 136 30/04/2004 p 34 – 57 This text does not contain the Annex to Directive 2001/83/EC The Annex currently in force DA: 53 PA: 5 MOZ Rank: 67 Directive 2001/95 EC - product safety

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directive 2001

Directive 2004/27/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 – 136 30/04/2004 p 34 – 57 This text does not contain the Annex to Directive 2001/83/EC The Annex currently in force DA: 50 PA: 89 MOZ Rank: 82 Directive 2001/95 EC - product safety

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Contents

Consolidated versions of the Treaty on European Union and the Treaty on the Functioning of the European Union 2010/C 83/ and the Charter of Fundamental Rights of the European Union (2010/C 83/02) 15 1 2 Charter of Fundamental Rights of the European Union (2010/C 83/02) 28 Chapter II Public Health 31 Blood 31 2 1 Directive 2002/98/EC of the European Parliament and of the Council of 27

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directive 2001

Directive 2004/27/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 – 136 30/04/2004 p 34 – 57 This text does not contain the Annex to Directive 2001/83/EC

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Opinions n C

1 In this reference for a preliminary ruling the High Court of Justice (England Wales) Queen-s Bench Division (Administrative Court) (United Kingdom) requests the Court to interpret Article 28 of Directive 2001/83/EC ( 2 ) (-Directive 2001/83- or -the Directive-) which establishes a procedure for the mutual recognition of marketing authorisations for medicinal products

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directive 2001

Directive 2004/27/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 – 136 30/04/2004 p 34 – 57 This text does not contain the Annex to Directive 2001/83/EC The Annex currently in force DA: 97 PA: 38 MOZ Rank: 77

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Updated Guidance on Transitional arrangements for the

Consolidated Guidance on Transitional arrangements for the Directive on traditional herbal medicinal products (Directive 2004/24/EC amending Directive 2001/83/EC) This note updates and consolidates guidance previously issued in response queries received

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directive 2001

Directive 2004/27/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 – 136 30/04/2004 p 34 – 57 This text does not contain the Annex to Directive 2001/83/EC The Annex currently in force DA: 33 PA: 95 MOZ Rank: 22

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directive 2001

Directive 2004/27/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 – 136 30/04/2004 p 34 – 57 This text does not contain the Annex to Directive 2001/83/EC The Annex currently in force DA: 76 PA: 61 MOZ Rank: 97

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DIRECTIVE 2001/82/EC OF THE EUROPEAN PARLIAMENT AND OF

March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medical products Official Journal L – 136 30/04/2004 p 58 -84 This text does not contain the Annex to Directive 2001/82/EC DISCLAIMER: THIS TEXT IS AN INFORMAL CODIFICATION TO FACILITATE WORK WITH THE RELEVANT LEGISLATION ONLY THE VERSIONS AS PUBLISHED IN THE OFFICIAL

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Contents

Consolidated versions of the Treaty on European Union and the Treaty on the Functioning of the European Union 2010/C 83/ and the Charter of Fundamental Rights of the European Union (2010/C 83/02) 15 1 2 Charter of Fundamental Rights of the European Union (2010/C 83/02) 28 Chapter II Public Health 31 Blood 31 2 1 Directive 2002/98/EC of the European Parliament and of the Council of 27

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2001/83/EC of the European Parliament and of the Council

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 (Consolided version: 16/11/2012) Kurztitel: Directive 2001/83/EC Consolidated Version

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Outline of clinical research

The following outline is provided as an overview of and topical guide to clinical research: Clinical research is the aspect of biomedical research that addresses the assessment of new pharmaceutical and biological drugs medical devices and vaccines in humans

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B REGULATION (EC) No 273/2004 OF THE EUROPEAN

Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284 31 10 2003 p 1) (4) In the context of the enlargement of the European Union it is important to replace Directive 92/109/EEC by a regulation as

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