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European Medicines Agency

European Medicines Agency, Total:51 items.

In the international standard classification, European Medicines Agency involves: Law. Administration, Company organization and management, FOOD TECHNOLOGY.

IX-EU/EC, European Medicines Agency

• COM(2013) 472 FINAL-2013 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (2013/0222 (COD); Text with EEA relevan
• COM(2008) 664 FINAL-2008 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medic
• NO 1647/2003-2003 COUNCIL REGULATION amending Regulation (EEC) No 2309/93 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the evaluation of Medicinal Products
• COM(2002) 735 FINAL-2002 Modified proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying down Community procedures for the authorisation and supervision and pharmacovigilance of medicinal products for human and veterinary use and establishing a European Ag
• M 318-2002 MANDATE ADDRESSED TO CEN/CENELEC/ETSI FOR STANDARDISATION IN THE FIELD OF AIR TRAFFIC MANAGEMENT SYSTEMS AND GALILEO LOCAL COMPONENTS
• 2007/C 266/06-2007 Medicinal products - List of marketing authorisations granted by the EEA EFTA States for the second half of 2006 Subcommittee I - On the free movement of goods
• EC/1907/2006 CORR-2006 REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation
• 2004/9/EC-2004 DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the inspection and verification of good laboratory practice (GLP) (Codified version; Text with EEA relevance)
• NO 1394/2007-2007 REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004
• COM(2014) 557 FINAL-2014 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a Europ
• NO 1084/2003-2003 COMMISSION REGULATION concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State
• 2008/C 330/07-2008 Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 November 2008 to 30 November 2008
• 2008/C 77/03-2008 Summary of Community decisions on marketing authorizations in respect of medicinal products
• 2008/C 19/05-2008 Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2007 to 31 December 2007
• 2008/C 104/06-2008 Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2008 to 31 March 2008
• 2007/C 288/05-2007 Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2007 to 31 October 2007
• 2008/C 77/02-2008 Summary of Community decisions on marketing authorizations in respect of medicinal products
• 2008/C 242/08-2008 Guideline on aspects of the application of Article 8(1) and (3) of Regulation (EC) No 141/2000: Assessing similarity of medicinal products versus authorised orphan medicinal products benefiting from market exclusivity and applying derogations from that ma
• COM(2002) 529 FINAL-2002 Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the inspection and verification of good laboratory practice (GLP)(codified version)
• 2001/20/EC-2001 Directive of the European Parlament and of the Council 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
• 2010/C 111/03-2010 Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2010 to 28 February 2010
• 2007/47/EC-2007 DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and
• EC/1907/2006 CORR-2008 CORRIGENDA Corrigendum to Regulation the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive
• 91/356/EEC-1991 Commission Directive Laying down the Principles and Guidelines of Good Manufacturing Practice for Medicinal Products for Human Use
• COM(2008) 668 FINAL-2008 Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or sou
• 2004/10/EC-2004 DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests
• 2008/C 104/05-2008 Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2008 to 31 March 2008
• 2009/C 24/06-2009 Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2008 to 31 December 2008
• NO 668/2009-2009 COMMISSION REGULATION implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by mic
• 2008/C 114/13-2008 Notice to users of controlled substances in the European Union allowed for essential uses in the Community in 2009 under Regulation (EC) No 2037/2000 of the European Parliament and of the Council on substances that deplete the ozone layer
• COM(2002) 530 FINAL-2002 Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applicat
• 2014/C 337/02-2014 Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2014 to 31 August 2014 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Coun
• 2015/C 148/02-2015 Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2015 to 31 March 2015 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Counci
• 2008/C 56/07-2008 Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2008 to 31 January 2008
• 2010/C 111/02-2010 Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2010 to 28 February 2010
• 2008/C 114/11-2008 Notice to importers in the European Union that propose to import in 2009 controlled substances that deplete the ozone layer under Regulation (EC) No 2037/2000 of the European Parliament and of the Council on substances that deplete the ozone layer
• COM(2013) 443 FINAL-2013 REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Better Medicines for Children - From Concept to Reality General Report on experience acquired as a result of the application of Regulation (EC) No 1901/2006 on medicinal products for pa

EU/EC - European Union/Commission Legislative Documents, European Medicines Agency

• COM(2016) 498 FINAL-2016 REPORT FROM THE COMMISSION Pharmacovigilance related activities of Member States and the European Medicines Agency concerning medicinal products for human use (2012 – 2014) (SWD(2016) 284 final)
• NO 1907/2006 CORR-2008 CORRIGENDA Corrigendum to Regulation the European Parliament and of the Council of 18 December 2006 concerning the Registration@ Evaluation@ Authorisation and Restriction of Chemicals (REACH)@ establishing a European Chemicals Agency@ amending Directive 1
• 2013/C 250/02-2013 Summary of European Union decisions on marketing authorisations in respect of medicinal products (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
• COM(2017) 135 FINAL-2017 REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL in accordance with Article 59(4) of 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
• 2009/C 231/06-2009 Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 August 2009 to 31 August 2009 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of
• 2015/C 176/02-2015 Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2015 to 30 April 2015 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Counci

Group Standards of the People's Republic of China, European Medicines Agency

• T/CSZX 001.16-2021 Standardization and Standardization Construction Specifications of Grass-roots Bureau of Market Supervision and Administration Bureau Part Sixteen: Supervision of Drugs, Medical Devices and Cosmetics

European Committee for Standardization (CEN), European Medicines Agency

• CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
• EN 737-2:1999/A1:1999 AMD A1 Medical Gas Pipeline Systems - Part 2: Anaesthetic Gas Scavenging Disposal Systems - Basic Requirements Ratified European Text

Association Francaise de Normalisation, European Medicines Agency

• FD S99-212*FD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
• FD CEN/TR 17223:2018 Document d'orientation sur la relation entre l'EN ISO 13485:2016 (Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires) et le Règlement européen relatif aux dispositifs médicaux ainsi que le Règle...

CEN - European Committee for Standardization, European Medicines Agency

• PD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

CEPT - Conference Europeenne des Administrations des Postes et des Telecommunications, European Medicines Agency

• CEPT T/PET 1-1974 Objectifs A Suivre Et Actions A Entreprendre Par Les Adnibistrations Des Postes Et Des Telecommunications@ Dans Le Cadre De La Mise En Oeuvre D'Une Politique Europeenne De Teleinformatique

Institute of Electrical and Electronics Engineers (IEEE), European Medicines Agency

• ISO/IEC 8802-11:2005/Amd.5:2006(E) IEEE Std 802.11h-2003 ISO/IEC International Standard - Information technology-- Local and metropolitan area networks-- Part 11: Amendment 5: Spectrum and Transmit Power Management Extensions in the 5 GHz band in Europe

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