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Directive 2001/83/ec consolidated

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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, 28.11.2001, p. 67) Amended by: Official Journal No page date M1 Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 L 33 30 8.2.2003 M2 Commission directive 2003/63/EC of 25 June 2003 L 159 46 27. 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, 28.11.2001, p. 67-128 (ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV) Special edition in Czech: Chapter 13 Volume 027 P. 69 - 13 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; Table of contents ; Table of Contents; Content; More Resources; Plain View; Print Options; What.

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

Consolidated Version of Directive 2001/83/EC on the Community code relating to medicinal products for human use This document is for documentation purposes only. AESGP does not assume any liability for its contents 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; Whole Directive; Table of Contents; Content; More Resources; Previous; Next; Plain View; Print. 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 - 12

Directive 2001/83/EC 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, 25.11.2014, p. 1. 5 representing manufacturers, wholesale distributors and pharmacies in June 2011, December 2012, December 2013 and April 2014. In addition, a public consultation was. 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) 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/EU Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance (OJ L. Die Richtlinie 2001/83/EG kodifiziert Grundsätze zur Herstellung, Zulassung, zum Inverkehrbringen und zur Überwachung von Humanarzneimitteln. Damit sind zur Verwirklichung des Europäischen Binnenmarktes für Arzneimittel technisch-wissenschaftliche Hürden abgebaut worden

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

Trials Directive 2001/20/EC: 7 February 2012 Date of publication: 12/04/2012 Date of entry into force: N/A Supersedes: Version 9.0 of August 2011 Changes compared to superseded version 9.0: New Q&A: 4.1 Keywords: Clinical trials, Directive 2001/20/EC, Directive 2005/28/EC, Questions and Answers Important notice: The views expressed in this questions and answers document are not legally. 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 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 Union. MainSearch. search . More Advanced search Browse by subject Expert Search. Language Selector. BasketSummary. 0. Directive 2001/83/EC (consolidated version 16/11/2012) of November 2001 relating to medicinal products for human use; Regulation (EC) No 726/2004 (consolidated version 5/6/2013) of March 2004 on procedures for the authorisation and supervision of medicines for human and veterinary use and establishing the European Medicines Agency

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 Legal instrument: Directive: Number legal act: Directive 2001/83: Original proposal: COM(1999)315: CELEX number i: 32001L0083: 3. Key dates. Document: 06-11-2001: Publication in Official Journal: 28-11-2001; OJ L 311, 28.11.2001,Special. 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 (Consolided version : 21/07/2011). 2012/26/EU Directive 2012/26/EU of the European Parliament and of the Council of 25 October 201 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 JOURNAL OF THE EUROPEAN COMMUNITY. products for human use, which have been consolidated in Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use, which is the subject of this proposal for amendment. The word adaptation must be particularly stressed in this connection since, although procedural arrangements or other provisions need to be amended or.

directive 2001/83/ec consolidated directive 2001/83/ec summary 2001/82/ec 2001/20/ec directive 2004/27/ec Eggs (Labelling and Sale) Act 2001. A2001-83. Minister for Justice, Consumer Affairs and Road Safety—Justice and Community Safety Directorate 6 Nov 2001 DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF active substance with principles and guidelines of good manufac-. CAC/GL 38-2001. Directive 2001/83/EC. Key-words. Directive 2001/83/EC — Medicinal products for human use — Marketing authorisation — Article 8(3)(i) — Requirement to attach to the application for authorisation the results of pharmaceutical pre-clinical tests and clinical trials — Derogations relating to pre-clinical tests and clinical trials — Article 10a — Medicinal products of which the active.

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Directive 2001/83/EC or Regulation (EC) No 726/2004 of the European Parliament and of the Council (1), as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part are concerned. 9. Any device which is intended to administer a medicinal product as defined in point. Directive 2001/83/EC. Under Directive 2001/83/EC, EU Data Exclusivity laws guaranteed marketing protection, against use of the data for filing an abridged licence, for the originator of medicines for either 6 or 10 years. This Directive applied in respect of first EU authorisations up to and including 31st October 2005. The first EU marketing authorisation date is the earliest date that a.

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. Directive 2001/83/EC. 18.12.2001-OJ L 311 of 28.11.2001, pp. 67-128. Successive amendments and corrections to Directive 2001/83/EC have been incorporated into the basic text. This consolidated version is for information only. RELATED ACTS. Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products. las radiaciones ionizantes (1) cuyo objetivo es evitar laexposición de trabajadores o pacientes a radiaciones ionizantes de nivel excesivo o innecesariamente elevado y, en particular, la letra c) de su artículo 5, que exige u Directive 2001/83/EC with regard to the medicinal product. 4. Where an active implantable medical device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action that is ancillary to that of the device, that device shall.

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

  1. EC/1394/2007 Regulation of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Note: shall apply from 30 December 2008)(consolidated vers
  2. Directives. 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. Download. 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 : 21/07/2011) Commission Directive 2003/63/EC.
  3. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance
  4. the 2001 Directive means Directive . 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products fo
  5. Directive 2001/83 / EC (German only) Consolidated version of the AMG on the basis of the version of the notice of 12 December 2005 (Federal Law Gazette I p. 3394), as last amended by Article 1 of the Act to update the regulations for blood and tissue preparations and to amend other regulations of 18.07.2017, came into force on 29.07.2017 (German only) Implementation of Regulatory Requirements.
  6. on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof, Having regard to the proposal from the European Commission.

2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products. (Official Journal L 168, 30/6/2009, p. 33 - 34). 2009/9/EC Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for. Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device, the safety, quality and usefulness of the substance must be verified, taking account of the intended purpose of the device, by analogy with the methods specified in Annex 1 to Directive 2001/83/EC. Continued on next page : European Medical Device Directive - Essential Requirements.

EudraLex - Volume 1 - Pharmaceutical legislation for

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on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 . Delegations will find in the Annex to this document the tentatively agreed consolidated compromise text of the proposed Regulation on medical devices resulting from the negotiations between the Council and the European Parliament

CONSOLIDATED FINAL - 15 August 2013 edited Page 1 of 23 EFPIA HCP CODE EFPIA CODE ON THE PROMOTION OF PRESCRIPTION-ONLY MEDICINES TO, AND INTERACTIONS WITH, HEALTHCARE PROFESSIONALS Adopted by EFPIA Board on 5 July 2007, and ratified by the EFPIA Statutory General Assembly of 19 June 2008 as amended by the Statutory General Assembly on 14 June 2011 - amending Article 17 on Medical Samples. Medical Devices Council Directive 93/42/EEC Annex I (consolidated as per 2007/47/EEC) BS EN ISO 8185:2009 Basis of Compliance: Product compliance has been based on in-house testing, external evaluation, evaluation of sales/complaints history, equivalence to other products or a combination of this data. Product Status: (New or Well Established): Well Established product Released 12 December. (1) Council Directive M5 2001/83/EC of 14 June 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products and laying down special provisions for medicinal products derived from human blood or human plasma (OJ. Seventh Directive: Consolidated accounts of companies with limited liability (Directive 83/349/EEC of 29/6/83) Eighth Directive: Qualifications of persons responsible for carrying out the statutory audits of accounting documents (Official Journal L126 of 12.5.1984, on EUR-Lex) Communication COM(2003)286 related to the Eighth Directive, of the Commission of 21 May 2003: Reinforcing the.

Richtlinie 2001/83/EG (Gemeinschaftskodex für

  1. Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance (OJ L 299, 27.10.2012, p. 1), (hereinafter: Directive 2001/83/EC). - Article 47 of the Act or Article 10a of Directive 2001/83/EC, if the subject possesses the rights of original manufacturer
  2. (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 (4), codified and consolidated in a single text the texts of Community legislation on medicinal products for human use, in the interests of clarity and rationalisation
  3. istrative action relating to medicinal products (OJ No L 147 of 9. 6. 1975, p. 13) (As amended by Directives 83/570/CEE (OJ No L 332 of 28. 11. 1983, p. 1), 89/341/CEE (OJ No L 142 of 25. 5. 1989, p. 11), 89/342/CEE (OJ No L 142 of 25. 5. 1989, p. 14), 89/343.

Directive 2001/83/EC - Wikipedi

Europe -Consolidated directive 2001/83/EC Summary: Wholesale Distribution of Medicinal Products must comply with GDP established by the Commission: •Principle •Personnel •Documentation •Premises and equipment •Deliveries to customers •Self inspections •Provision of Information to Member States in relation to wholesale activities Of Note: •―The level of quality [of medicinal. Directive 2001/83/EC [medicinal products], Regulation (EC) No 178/2002 [food] and Regulation (EC) No 1223/2009 [cosmetic products] and repealing Council Directives 90/385/EEC [active implantable medical devices] and 93/42/EEC [medical devices] For recitals (i.e. the preface or reasoning for the regulation) see the original MDR (pdf) CONSOLIDATED FINAL - 15 August 2013 edited Page 2 of 23 TABLE OF CONTENTS PAGE INTRODUCTION Council Directive 2001/83/EC was amended in 2004 by Council Directive 2004/27/EC. The EFPIA HCP Code was further revised in 2004 to adopt various improvements and to make it fully consistent with Directive 2001/83/EC, as amended. This revised version of the EFPIA HCP Code was adopted by EFPIA on.

Legal framework: Advanced therapies European Medicines

Traduzioni in contesto per consolidated directive in inglese-italiano da Reverso Context: The 2002 consolidated Directive (CD Consolidated TEXT. Incorporating First Draft Revision dated 1 October 2004 to. COUNCIL DIRECTIVE 93/42/EEC. of 14 June 1993. concerning medical devices THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Preamble to be added. HAS ADOPTED THIS DIRECTIVE: Article 1. Definitions, scope. 1. This Directive shall apply to medical devices and their accessories. For the purposes of this. 15 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 as amended by Directive 2002/98/EC, Directive 2003/63/EC, Directive 2004/24/EC, Directive 2004/27/EC and Directive 2008/29/EC This Directive shall not apply to medicinal products as defined by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Communit

Directive 2001/83 - EC code relating to medicinal products

Directive 93/42/EEC - MDD - Medical Devices Directive with 2007/47/EC - Consolidated Version. Medical Devices Directive MDD 93/42/EEC - with 2007/47/EC - Consolidated Version Check Free Resources - Major European Regulations. TIP: Use the following Index to navigate into the different sections of the directive. Click on the arrow on the right corner to scroll up. [toc] B. COUNCIL. consolidated version 90/385/EEC - Emergo and/or therapeutic purposes and necessary for its proper application, COUNCIL DIRECTIVE of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC) (OJ L 189, 20.7.1990, p. 17) Amended by: Official Journal M1 M2 M3 M4 Council Directive 93/42/EEC of 14 June 1993 Council Directive. 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 (1); (b) natural mineral waters used at source for curative purposes in thermal or hydromineral establishments. 4. The grounds for granting the recognition referred to in paragraphs 1 and 2 shall be stated in due form by the responsible. Regulatory references and resources. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. 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: 30/12/2008). Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending.

EudraLex - Volume 1 - Pharmaceutical Legislationo

5. This Directive constitutes a specific Directive within the meaning of Article 1(4) of Directive 2004/108/EC ( 7 ). 6. This Directive shall not apply to: (a) medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of. 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 forc Traduzioni in contesto per directive consolidated in inglese-italiano da Reverso Context: This directive consolidated the previous directives on the subject, modifying their content and creating a simplified legal framework Viele übersetzte Beispielsätze mit consolidated extract - Deutsch-Englisch Wörterbuch und Suchmaschine für Millionen von Deutsch-Übersetzungen

Steps to Compliance with the European Medical Device

of Directive 2001/83/EC for medicinal products for human use, which the Commission accepted subject to rewording to take account of the need for any guidance proposed to be adopted by the Commission . eur-lex.europa.eu. eur-lex.europa.eu. Sie steht in Übereinstimmung mit der Spezifikation der GML (Geography Markup Language) und entspricht [...] dem in Anhang III [...] Nummer 18 genannten. borderline cases, which are consolidated and then published in a reference document (Manual of Decisions) available on the internet 6. The Manual is regularly updated. This document has been endorsed by the competent authorities of all Directives involved. General principles The Medicinal Product Directives (MPDs) are listed in Article 1(2) of Directive 98/8/EC. Article 1(2) excludes from the.

Guideline 2001 83 egg - Telegrap

Suggest as a translation of various consolidated Copy; DeepL Translator Linguee. EN. Open menu. Translator. Translate texts with the world's best machine translation technology, developed by the creators of Linguee. Linguee. Look up words and phrases in comprehensive, reliable bilingual dictionaries and search through billions of online translations. Blog Press Information. Linguee Apps. Directive may refer to: Directive is a consolidated version of the It replaces the text of the older directive... List Of Clinical Research Topics - Legislation, Regulations and Guidances - European Union... Directive 2001/20/EC Directive 2001/83/EC Directive 2005/28/EC Directive 65/65/EEC Directive 93/41/EEC Directive 95/46/EC on the protection of personal data Laboratory Animal. CONSOLIDATED FINAL 06 June 2014 - 11 July 2014 final editing Page 1 of 23 EFPIA HCP CODE EFPIA CODE ON THE PROMOTION OF PRESCRIPTION-ONLY MEDICINES TO, AND INTERACTIONS WITH, HEALTHCARE PROFESSIONALS Adopted by EFPIA Board on 5 July 2007, and ratified by the EFPIA Statutory General Assembly of 19 June 2008 as amended by the Statutory General Assembly on 14 June 2011 - amending Article 17. 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: 20/01/2011). OJ L 311, 28.11.2001, 67. URL:.

Reference medicinal product - Directive 2001/83/EC > EU

  1. Consolidated version of Directive 2001/83/EC with all its amendments. This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official.
  2. A new Regulation 2019/5 amending Regulation (EC) No 726/2004, Regulation (EC) No 1901/2006 and Directive 2001/83/EC was published today in the Official Journal of the European Union. You can.
  3. Directive 2001/83/EC, Directive 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 as amended by Directive 2002/98/EC, Directive 2003/63/EC, Directive 2004/24/EC, Directive 2004/27/EC and Directive 2008/29/EC
  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. (OJ L 311, 28.11.2001, p.67) This Directive has been amended several times since its adoption. An informal consolidated version is available from the Eur-Lex websit
  5. 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, 2001 O.J. (L 311/67, 94), art. 96, https://perma.cc/TSW3- DEP9. 4 Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 Supplementing Directive 2001/83/EC of the European Parliament and of the Council by Laying Down Detailed Rules.
  6. 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 as amended by Directive 2002/98/EC, Directive 2003/63/EC, Directive 2004/24/EC, Directive 2004/27/EC and Directive 2008/29/EC Google Scholar. Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004.
  7. The European Commission was given such power in article 54(a)2 of Directive 2001/83/EC and exercised this power when adopting Commission Delegated Regulation (EU) 2016/161, which details the rules for how safety features must appear on packaging of medicinal products within the EU. Thus, Member States are responsible for transposing the Directive into national law and must also implement rules.

To establish one common dossier template for applications for the registration (Article 14 of Directive 2001/83/EC, as amended) of homeopathic medicinal products in the EU, in co-operation with the Notice to Applicants Group This consolidated version of the IVDR is a service provided by Johner Institut GmbH for the purpose of readability and usability. There is no guarantee for completeness and correctness of the contents. Furthermore, this document is not an official legal text. With regard to the texts and references contained therein, please note that only the texts published in the European Official Journal. Die Richtlinie 93/42/EWG des Rates vom 14.Juni 1993 über Medizinprodukte ist eine von insgesamt drei Medizinprodukte-EU-Richtlinien und wird in Deutschland und Österreich kurz als Medizinprodukterichtlinie bezeichnet. International spricht man von der Richtlinie als Medical Device Directive (MDD), oder Directive 93/42/EEC.. Sie ist das wichtigste Regelungsinstrument zum Nachweis der. These consolidated regulations, prepared by the U.S. Department of Health and Human Services, These applications, marking the product safety within the acceptable range as per Directive 2001/83/EC, are not required to be accompanied by the preclinical and clinical data , however, the submission of quality reports, including the physicochemical, biological, and microbiological testing, are.

Data Exclusivity, Marketing Authorisation and Abridged

  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 (consolidated version: 16/11/2012). In: In: EudraLex—The Rules Governing Medicinal Products in the European Union, Volume 1: Pharmaceutical Legislation: Medicinal Products For Human Use
  2. 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: 85 PA: 68 MOZ Rank: 2
  3. 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: 43 PA: 47 MOZ Rank: 9
  4. Directive 2002/98/EC of the European Parliament and of the Council of the European Union of January 27 th, 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. [Accessed on 12/08/2013]
  5. authorisation, in accordance with article 24 of Directive 2001/83/EC as amended by Directive 2010/84/EC. Each application, whether authorised nationally or through mutual recognition, must be accompanied by the EU application form in order for it to be validated. A covering letter should also be included. Applicants should ensure the accuracy of all documentation submitted, including the.
  6. Amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. Official Journal L. 2003; 159 :46-94. Commission Directive 95/46/EC of the European Parliament and of the Council of 24 October on the protection of individuals with regard to the processing of personal data and on the free movement of such data

Directive 2001/83/CE du Parlement européen et du Conseil

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

EC/1394/2007 Regulation of the European Parliament and of

FINAL CONSOLIDATED VERSION 2019 Approved by the General Assembly of 27 June 2019 The EFPIA Code constitutes the collection of ethical rules agreed by EFPIA members for the Promotion of Medicinal Products to HCPs and the interactions with HCPs, HCOs and POs, with the intent of guaranteeing that these activities are conducted while respecting the most stringent ethical principles of. 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: 28 PA: 90 MOZ Rank: 1 Vertalingen van het uitdrukking DE GECODIFICEERDE RICHTLIJNEN van nederlands naar engels en voorbeelden van het gebruik van DE GECODIFICEERDE RICHTLIJNEN in een zin met hun vertalingen:overgangsperioden bevatten die destijds in de gecodificeerde richtlijnen waren toegekend maar die thans... Directive 2001/83/EC); c) informed consent (Section 27, paragraph 9 of the Act on Pharmaceuticals; Art. 10c of Directive 2001/83/EC); d) homeopathic product authorised via a simplified procedure (Section 28 of the Act on Pharmaceuticals; Art. 14 of Directive 2001/83/EC). 230 000 CZK R-003 Application for a marketing authorisation of 4 Changes to the information required in paragraphs 1-3 must be reported once a year to the Agency, in consolidated form. amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC; amended by OJ L 117 of 5.5.2017, p. 1. 2 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5.

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