EDQM Certificates of Suitability: Cooperation Among Inspectorates in Europe And Beyond
|
|
- Lucy Parsons
- 8 years ago
- Views:
Transcription
1 EDQM Certificates of Suitability: Cooperation Among Inspectorates in Europe And Beyond 14 th International Conference of Drug Regulatory Authorities Pre-ICDRA Meeting Dr Susanne Keitel European Directorate for the Quality of Medicines & HealthCare Council of Europe
2 Content The Council of Europe and EDQM The Certification Procedure The EDQM Inspection Program International Collaboration Inspection Statistics Outlook 2010 EDQM, Council of Europe, All rights reserved 2
3 The Council of Europe Founded on 5 May 1949 by 10 countries An international organisation in Strasbourg which comprises 47 countries of Europe. The primary aim of the Council of Europe is to create a common democratic and legal area throughout the whole of the continent, ensuring respect for its fundamental values: human rights, democracy and the rule of law EDQM, Council of Europe, All rights reserved 3
4
5 The EDQM The European Directorate for the Quality of Medicines & HealthCare (EDQM), a Directorate of the Council of Europe Our vision is to be a leader in protecting public health by establishing high quality standards for: medicines for human and veterinary use, blood transfusion and organ transplantation; the safe and appropriate medication; participating in programmes targeted towards the protection of consumer health EDQM, Council of Europe, All rights reserved 5
6 The Certification Procedure One out of three options to submit the quality documentation for an API in EU licensing procedures Referred to in the EU pharmaceutical legislation Open for substances covered by a Ph.Eur. Monograph Certifies that impurities can be adequately controlled by the monograph(s) Includes inspections 2010 EDQM, Council of Europe, All rights reserved 6
7 The Certification Procedure (cont.) Additional benefits: Centralised assessment of APIs: attractive to applicants and National Competent Authorities Identification of potential divergent practices by national assessors may contribute to more consistent assessment approaches across Europe 2010 EDQM, Council of Europe, All rights reserved 7
8 The Certificate of Suitability (CEP) Certifies that the quality of a given substance can be suitably controlled by the Ph.Eur. monograph - with additional tests, if necessary (stated on the CEP). It DOES NOT certify that a batch or batches of the substance complies with the Pharmacopoeia monograph. It IS NOT a GMP certificate 2010 EDQM, Council of Europe, All rights reserved 8
9 GMP Requirements for API Active substance must be produced according to EU GMP (Directives 2001/83/EC and 2001/82/EC) It is the responsibility of the MAH to ensure EU GMP compliance of the active substance manufacturer Declaration from the MAH Qualified Person(s) (QPs) in the MA (and any subsequent variation(s))
10 Challenges in A Globalised World Complex and fragmented supply chain with a growth in adulteration/counterfeiting activities Shift of API manufacture away from Europe Large number of API manufacturers involved, including increasing trade with intermediates, API starting materials and presence of alternative sources Increasing need for on-site verification of GMP compliance? 2010 EDQM, Council of Europe, All rights reserved 10
11 EDQM Inspection Program Part of the Certification Procedure, based on a mandate given by the European Commission Maybe performed before or after a CEP is granted Aim: to verify compliance with submitted dossier EU GMP Part II EU GMP Annexes (e.g. Annex 1 / sterile manufacture)
12 Selection of Sites Done in accordance with EU Commission guidance (EMEA/INSP/GMP/313538/ 2006) request from the assessors sterile substances may be several triggers involved re-inspection regulatory environment of the manufacturing site inspection by equivalent authority Based on a risk-based approach => NO routine inspections! 2010 EDQM, Council of Europe, All rights reserved 12
13 Legal Framework The Competent Authority may inspect an API manufacturer in order to ensure that the manufacturing authorisation holder of a medicinal product has fulfilled its obligations under Article 46 (f) and/or Article 50 (f) of the below mentioned Directives (Article 111 of Directive 2001/83/EC and Article 80 of Directive 2001/82/EC) 2010 EDQM, Council of Europe, All rights reserved 13
14 EDQM Inspection Program Draft annual program circulated to Member States for comments and presented to GMP/GDP Inspectors Working Group at EMA for discussion. Program adopted by Certification Steering Commitee. Final program circulated to all EEA Member States Competent Authorities 2010 EDQM, Council of Europe, All rights reserved 14
15 How The System Works Inspection performed by team, usually composed of EDQM inspector and inspector coming from EU/EEA or MRA National Competent Authority Compliance with submitted dossier and EU GMP verified EDQM informs local inspectorate about date and scope of inspection and welcomes participation of local inspectors as observers 2010 EDQM, Council of Europe, All rights reserved 15
16 EDQM and the EMA GMP/GDP Inspectors Working Group Discussion of EU Regulations, GMPs, GDPs Management of MRAs in the field of GMP Management of the Community Procedures EudraGMP database access International API Inspection Pilot Program (2007) Gathers authorities performing significant number of API inspections outside their territories: FR, DE, IE, IT, UK, EDQM, AU, US Aim: to make best use of inspectorates resources Based on sharing inspection reports or/and performing joint inspections 2010 EDQM, Council of Europe, All rights reserved 16
17 EDQM and GMP Inspectorates Inspections performed by team composed of EDQM inspector and inspector from EU/EEA or *MRA National Competent Authority Austria Czech Republic Denmark Finland France Germany Greece Hungary Ireland Italy Latvia Netherland Romania UK Sweden Spain *Switzerland *Australia + WHO 2010 EDQM, Council of Europe, All rights reserved 17
18 API Pilot Project Overall objective is to see whether greater international collaboration and information sharing can help: to better distribute inspection capacity, allowing more sites to be monitored and reducing unnecessary duplication EDQM, Council of Europe, All rights reserved 18
19 API Pilot Project Principles: Sharing of inspection reports of conducted inspections Sharing information on inspection planning Joint inspection with or without scope extension EDQM, Council of Europe, All rights reserved 19
20 API Pilot Project Involved Authorities: EU: France, Germany, Ireland, Italy, United Kingdom Council of Europe: EDQM MRA: Australia (TGA) US: FDA Current Status: Interim Report available ( Collaboration to continue 2010 EDQM, Council of Europe, All rights reserved 20
21 API Pilot Project Benefits for EDQM: - Broader coverage of manufacturing sites by using external inspection reports - suspension/restoration of CEPs (sterile) based on inspection/re-inspection performed by Germany - Joint inspections with TGA - Extension of the inspection s scope (i.e. covering an API subject to the CEP procedure) saved resources - International networking / confidence building 2010 EDQM, Council of Europe, All rights reserved 21
22 EDQM Inspection Statistics % 90% 80% 70% 60% 50% 40% 30% Elsewhere EEA Asia other China India 20% 10% 0% EDQM, Council of Europe, All rights reserved 22
23 Statistics (Exp) Number of EDQM inspections per year Outside EU/EEA EU/EEA EDQM, Council of Europe, All rights reserved 23
24 Statistics (Exp) EDQM Inspections Repartition of the number of inspector-days Sweden 3% Denmark 4% Spain 4% Norway 3% UK 3% Greece 3% Romania 9% EDQM 40% Italy 3% Switzerland 5% Finland 3% Germany 11% France 9% 2010 EDQM, Council of Europe, All rights reserved 24
25 2009 Review 29 sites inspected by EDQM 32 sites covered by exchange of information with other inspectorates 10 found non-compliant with EU GMP 3 sites borderline (follow-up on going) CEPs suspended: 11 Dossiers closed: 2 CEPs withdrawn after suspension due to negative re-inspection: 3 3 CEPs suspended for two manufacturing sites due to refusal to be inspected 2010 EDQM, Council of Europe, All rights reserved 25
26 Outlook Further develop risk-based approach when elaborating programme Reinforce collaboration and sharing of information with EEA and international inspectorates in order to optimise inspection ressources through: (Pilot) program for exchange of information on API (EMA) GMDP Inspectors Working Group: EEA members Committee of officials of PIC Scheme (PIC/S) Confidentiality agreement with PIC/S, TGA Australia, USFDA Confidentiality agreement with WHO being finalised EUDRA GMP database 2010 EDQM, Council of Europe, All rights reserved 26
27 Thank you for your attention! 2010 EDQM, Council of Europe, All rights reserved 27
Comparative analysis between the possible regulatory approaches to GMP compliance TITOLO PRESENTAZIONE
Comparative analysis between the possible regulatory approaches to GMP compliance TITOLO PRESENTAZIONE Dr. Fulvio CARLOTTI, GNOSIS SpA, Corporate QA Director September 26, 2014 Scope of GMP GMP compliance
More informationQUESTIONS AND ANSWERS ABOUT THE EDQM ACTIVITIES
QUESTIONS AND ANSWERS ABOUT THE EDQM ACTIVITIES Why are Pharmacopoeias so important in a globalised world? Pharmacopoeias have historically provided collections of medical recipes intended to ensure accurate
More information1. Name of pharmacopoeia
1 1. Name of pharmacopoeia European Pharmacopoeia 36 Member states (Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,
More informationThe European regulatory system for medicines and the European Medicines Agency
The European regulatory system for medicines and the European Medicines Agency A consistent approach to medicines regulation across the European Union An agency of the European Union This booklet is intended
More informationGMP and QMS Regulation in Japan
GMP and QMS Regulation in Japan Tomiko Tawaragi Chief Safety Officer Pharmaceuticals and Medical Devices Agency (PMDA) August 2 nd, 2014 1 st Brazil-Japan Seminar GMP/QMS GMP : Good Manufacture Practice
More informationWork plan for GMP/GDP Inspectors Working Group for 2016
21 December 2015 EMA/INS/GMP/738756/2015 Compliance and Inspection Work plan for GMP/GDP Inspectors Working Group for 2016 Chairperson: Status David Cockburn January 2016 1. Meetings scheduled for 2016
More informationHarmonizing Change Control Processes Globally
Quality & Compliance Associates, LLC Harmonizing Change Control Processes Globally President Quality & Compliance Associates, LLC When We Deal In A Global Environment, How Do We Design A System That Addresses
More informationEmployee eligibility to work in the UK
Employee eligibility to work in the UK This document details legal requirements that apply to ALL new members of staff All employers in the UK are legally bound to comply with the Asylum and Immigration
More informationReport from the CMDh meeting held on 21-23 September 2015. !!! 3 months to go until the mandatory use of the electronic application form!!!
Report from the meeting held on 21-23 September 2015!!! 3 months to go until the mandatory use of the electronic application form!!! Pharmacovigilance positions following PSUSA procedure for only nationally
More informationClinical trials submitted in marketing-authorisation applications to the European Medicines Agency
11 December 2013 EMA/INS/GCP/676319/2012 Compliance and Inspection Clinical trials submitted in marketing-authorisation applications to the European Medicines Agency Overview of patient recruitment and
More informationPlanned Healthcare in Europe for Lothian residents
Planned Healthcare in Europe for Lothian residents Introduction This leaflet explains what funding you may be entitled to if you normally live in Lothian (Edinburgh, West Lothian, Midlothian and East Lothian
More informationSURVEY ON THE TRAINING OF GENERAL CARE NURSES IN THE EUROPEAN UNION. The current minimum training requirements for general care nurses
SURVEY ON THE TRAINING OF GENERAL CARE NURSES IN THE EUROPEAN UNION This survey serves as a background document for the discussion of the Commission's legislative proposal to modernize the minimum requirements
More informationWorking Party on Control of Medicines and Inspections. Final Version of Annex 16 to the EU Guide to Good Manufacturing Practice
Version 8 (final) EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market, regulatory environment, industries under vertical legislation Pharmaceuticals and cosmetics Brussels, July 2001 S\common\legal-legislation\75-319nd81-851\91-356\eudralexvol4\Annex
More informationHow companies leverage quality and quality certifications to achieve competitive advantage
How companies leverage quality and quality certifications to achieve competitive advantage Eize de Boer Systems & Services Certification International Business Development Manager Pharma Supply Chain for
More informationMutual recognition between the EU member states: official framework for collaboration saves resources?
Mutual recognition between the EU member states: official framework for collaboration saves resources? Alar Irs, Estonia Pre-ICDRA meeting, Nov 28-29, 2010 Effective collaboration: the future for medicines
More informationREPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL
EUROPEAN COMMISSION Brussels, 25.9.2014 COM(2014) 592 final REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the implementation in the period from 4 December 2011 until 31 December
More informationFamily benefits Information about health insurance country. Udbetaling Danmark Kongens Vænge 8 3400 Hillerød. A. Personal data
Mail to Udbetaling Danmark Kongens Vænge 8 3400 Hillerød Family benefits Information about health insurance country A. Personal data Name Danish civil registration (CPR) number Address Telephone number
More informationGMP Issues for Start-Ups, quality in the supply chain and role of the Qualified Person (QP)
GMP Issues for Start-Ups, quality in the supply chain and role of the Qualified Person (QP) Presented by: Patrick Costello Scientific Administrator, European Medicines Agency An agency of the European
More informationQUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES
PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 002-3 25 September 2007 RECOMMENDATION ON QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES PIC/S September
More informationThis factsheet contains help and information for financial advisers who wish to advise their clients who live in Europe.
Financial Conduct Authority Factsheet No.025 Investment advisers Passporting This factsheet contains help and information for financial advisers who wish to advise their clients who live in Europe. Introduction
More informationEUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY VERSION 7
EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health systems and products Medicinal products quality, safety and efficacy Brussels, IMPORTATION OF ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS
More informationThe coordination of healthcare in Europe
The coordination of healthcare in Europe Rights of insured persons and their family members under Regulations (EC) No 883/2004 and (EC) No 987/2009 Social Europe European Commission The coordination of
More informationERASMUS+ MASTER LOANS
ERASMUS+ MASTER LOANS Erasmus+ Master Loan: opening up access to more affordable lending for cross-border studies The Erasmus+ programme makes it possible for students who want to take a full Masters level
More information4. We understand this to mean that each provider state will need to ensure indemnity arrangements are in place to cover healthcare provided in that
Medical Defence Union response to consultation on European Commission s proposals for Directive on the application of patients rights in cross-border healthcare Introduction 1. The Medical Defence Union
More informationClinical trials in developing countries submitted to EMEA for regulatory purposes
Clinical trials in developing countries submitted to EMEA for regulatory purposes Rome, UNICRI/AIFA December 2008 Hans-Georg Eichler Agenda Challenges EU regulatory requirements for clinical trials Facts
More informationEuropean Surveillance of Veterinary Antimicrobial Consumption (ESVAC):
4 Focus Veterinary medicines European Surveillance of Veterinary Antimicrobial Consumption (ESVAC): Establishment of the project and key outputs Authors Kari Grave, ESVAC National Expert; David Mackay,
More informationHow many students study abroad and where do they go?
From: Education at a Glance 2012 Highlights Access the complete publication at: http://dx.doi.org/10.1787/eag_highlights-2012-en How many students study abroad and where do they go? Please cite this chapter
More informationEUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL VERSION 4.1
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products quality, safety and efficacy Brussels, SANCO/D/6/SF/mg/ddg1.d.6(2013) IMPORTATION OF ACTIVE SUBSTANCES
More informationElectricity, Gas and Water: The European Market Report 2014
Brochure More information from http://www.researchandmarkets.com/reports/2876228/ Electricity, Gas and Water: The European Market Report 2014 Description: The combined European annual demand for electricity,
More informationCompilation of Community Procedures on Inspections and Exchange of Information
EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE- GENERAL Public Health and Risk Assessment Pharmaceuticals 3 October 2014 EMA/572454/2014 Rev 17 Compliance and Inspection Compilation of Community
More informationGuideline on dossier requirements for Type IA and IB notifications
Guideline on dossier requirements for Type IA and IB notifications In accordance with Regulation (EC) No 726/2004 and Directives 2001/83/EC and 2001/82/EC, a common approach to the procedures for variations
More informationDelegation in human resource management
From: Government at a Glance 2009 Access the complete publication at: http://dx.doi.org/10.1787/9789264075061-en Delegation in human resource management Please cite this chapter as: OECD (2009), Delegation
More informationGUIDE FOR OVERSEAS APPLICANTS
Nursing and Midwifery Board of Ireland (NMBI) GUIDE FOR OVERSEAS APPLICANTS 1 CONTENTS Introduction 3 About this guide 3 Glossary of terms 4 The Register of Nurses and Midwives 5 Applying for registration
More informationORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT
2 OECD RECOMMENDATION OF THE COUNCIL FOR ENHANCED ACCESS AND MORE EFFECTIVE USE OF PUBLIC SECTOR INFORMATION ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT The OECD is a unique forum where the
More informationACP-NEP Co-ord (Smith, Lyn C2) Military Goods: A400M Collaborative Programme OPEN GENERAL EXPORT LICENCE APRIL 2014
ACP-NEP Co-ord (Smith, Lyn C2) OPEN GENERAL EXPORT LICENCE Military Goods: A400M Collaborative Programme APRIL 2014 - This page has been left intentionally blank - - 2 - April 2014 Open General Export
More informationPUBLIC VS. PRIVATE HEALTH CARE IN CANADA. Norma Kozhaya, Ph.D Economist, Montreal economic Institute CPBI, Winnipeg June 15, 2007
PUBLIC VS. PRIVATE HEALTH CARE IN CANADA Norma Kozhaya, Ph.D Economist, Montreal economic Institute CPBI, Winnipeg June 15, 2007 Possible private contribution Possible private contribution in the health
More informationCABINET OFFICE THE CIVIL SERVICE NATIONALITY RULES
ANNEX A CABINET OFFICE THE CIVIL SERVICE NATIONALITY RULES Introduction The Civil Service Nationality Rules concern eligibility for employment in the Civil Service on the grounds of nationality and must
More informationGMP Advisor The GMP Questions & Answers Guide Version 01 of April 2014
GMP Advisor The GMP Questions & Answers Guide Version 01 of April 2014 Page 1 of 152 About this document Searching for concrete answers to GMP questions is a time-consuming activity. This document is intended
More informationReport on Government Information Requests
Report on Government Information July 1 - December 31, 2014 apple Apple takes our commitment to protecting your data very seriously and we work incredibly hard to deliver the most secure hardware, software
More informationSUPPLEMENTARY PROTECTION CERTIFICATES FOR MEDICINAL PRODUCTS
SUPPLEMENTARY PROTECTION CERTIFICATES FOR MEDICINAL PRODUCTS A Supplementary Protection Certificate (SPC) is an Intellectual Property right which can give up to five extra years of exclusivity after a
More informationCOMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP)
European Medicines Agency Veterinary Medicines and Inspections London, 15 April 2005 EMEA/CVMP/134/02 Rev 1 CPMP/QWP/227/02 Rev 1 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY
More informationReflection Paper on Medicinal Product Supply Shortages Caused by Manufacturing/GMP Compliance Problems
14 September 2012 /590745/2012 Patient Health Protection Reflection Paper on Medicinal Product Supply Shortages Caused by Manufacturing/GMP 1. Introduction Ensuring the security and Good Manufacturing
More informationCanadian Pharmaceutical GMP
Canadian Pharmaceutical GMP Regulations Compared and Contrasted to USFDA GMPs by Richard K. Pike Reference Document Canada The Health Canada revised guidance Document entitled Good Manufacturing Practices
More informationStudents: undergraduate and graduate students who are currently enrolled in universities
DUO-Korea: 1. General Description CAUTION: If any application falls under the following 3 cases, the application is disqualified and will not be considered for selection. If such case is found after the
More information41 T Korea, Rep. 52.3. 42 T Netherlands 51.4. 43 T Japan 51.1. 44 E Bulgaria 51.1. 45 T Argentina 50.8. 46 T Czech Republic 50.4. 47 T Greece 50.
Overall Results Climate Change Performance Index 2012 Table 1 Rank Country Score** Partial Score Tendency Trend Level Policy 1* Rank Country Score** Partial Score Tendency Trend Level Policy 21 - Egypt***
More informationCULTURAL AND CREATIVE SECTORS GUARANTEE FACILITY
CULTURAL AND CREATIVE SECTORS GUARANTEE FACILITY OPEN CALL FOR EXPRESSION OF INTEREST TO SELECT FINANCIAL INTERMEDIARIES UNDER THE CULTURAL AND CREATIVE SECTORS GUARANTEE FACILITY (Published on 18th July
More informationKeeping European Consumers safe Rapid Alert System for dangerous non-food products 2014
Keeping European Consumers safe Rapid Alert System for dangerous non-food products 2014 COMPLETE STATISTICS Justice and Consumers Directorate-General for Justice and Consumers Directorate Consumers Unit
More informationERASMUS+ MASTER LOANS
Ref. Ares(2015)660570-17/02/2015 ERASMUS+ MASTER LOANS Erasmus+ Master Loan: opening up access to more affordable lending for cross-border studies The Erasmus+ programme makes it possible for students
More informationPLANT PROTECTION AND BIOCIDAL PRODUCT AUTHORISATION IN EUROPE
PLANT PROTECTION AND BIOCIDAL PRODUCT AUTHORISATION IN EUROPE THE TSGE GROUP AT A GLANCE THE TSGE GROUP D espite efforts to harmonise legislation and apply the principle of mutual recognition, the process
More informationERASMUS FOR YOUNG ENTREPRENEURS : A NEW EXCHANGE PROGRAMME
PRESS DOSSIER INDEX PRESS DOSSIER...1 INDEX...2 ERASMUS FOR YOUNG ENTREPRENEURS : A NEW EXCHANGE PROGRAMME...3 WHO CAN PARTICIPATE?...5 WHAT BENEFITS AND FOR WHOM?...6 HOW DOES IT WORK? STRUCTURE AND IMPLEMENTATION...7
More informationInternational Hints and Tips
International Hints and Tips Content Q: What is the cut off time for processing International payments? A: International payments must be submitted and fully approved within the cut off time indicated
More informationFEDERATION EUROPEENNE DE LA MANUTENTION Product Group. industrial trucks. A brief guide for identification of noncompliant. - Exhaust Emission -
FEDERATION EUROPEENNE DE LA MANUTENTION Product Group Industrial Trucks FEM A brief guide for identification of noncompliant industrial trucks 11.2010 (E) - Exhaust Emission - I n d e x 1 Introduction...
More informationThe value of accredited certification
Certified Once Accepted Everywhere The value of accredited certification Survey Report Published May 212 In 21/11, the IAF carried out a global survey to capture market feedback on the value of certification.
More informationCompilation of Community Procedures on Inspections and Exchange of Information
EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE- GENERAL Public Health and Risk Assessment Pharmaceuticals 27 June 2013 EMA/385898/2013 Rev 16 Compliance and Inspection Compilation of Community
More informationResponse to the European Commission s consultation on the legal framework for the fundamental right to protection of personal data
Stockholm: Göteborg: Malmö: 105 24 Stockholm Box 57 Box 4221 Fax 08 640 94 02 401 20 Göteborg 203 13 Malmö Plusgiro: 12 41-9 Org. Nr: 556134-1248 www.intrum.se Bankgiro: 730-4124 info@se.intrum.com Response
More informationPROCEDURE FOR HANDLING RAPID ALERTS AND RECALLS ARISING FROM QUALITY DEFECTS
PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 010-4 3 Appendices 1 January 2011 STANDARD OPERATING PROCEDURE PROCEDURE FOR HANDLING RAPID ALERTS AND RECALLS ARISING
More information2 ND CALL FOR PROPOSALS 27 October 2008 30 January 2009
2 ND CALL FOR PROPOSALS 27 October 2008 30 January 2009 1. INTRODUCTION Authorities and stakeholders at local and regional level have a vital role to play in the achievement of the EU s strategies for
More informationWaste. Copenhagen, 3 rd September 2014. Almut Reichel Project Manager Sustainable consumption and production & waste, European Environment Agency
Waste Copenhagen, 3 rd September 2014 Almut Reichel Project Manager Sustainable consumption and production & waste, European Environment Agency Waste and material resources MAWP Strategic Area 1.9 Objective
More informationGUIDE FOR OVERSEAS APPLICANTS
GUIDE FOR OVERSEAS APPLICANTS 1 CONTENTS Introduction 3 About this guide 3 Glossary of terms 4 The Register of Nurses and Midwives 5 Applying for registration in a division of the Register 6 Application
More informationENTERING THE EU BORDERS & VISAS THE SCHENGEN AREA OF FREE MOVEMENT. EU Schengen States. Non-Schengen EU States. Non-EU Schengen States.
ENTERING THE EU BORDERS & VISAS THE SCHENGEN AREA OF FREE MOVEMENT An area without internal borders where EU citizens and non-eu nationals may move freely EU Schengen States Non-Schengen EU States IS Azores
More informationÖNORM EN 1504-8. The European Standard EN 1504-8 has the status of an Austrian Standard. Edition: 2005-02-01. Standards group B
ÖNORM EN 1504-8 Edition: 2005-02-01 Standards group B Identical (IDT) with EN 1504-8:2004 ICS 91.080.40 Products and systems for the protection and repair of concrete structures Definitions, requirements,
More informationNew environmental liabilities for EU companies
New environmental liabilities for EU companies The ELD applies to all businesses that operate within the EU, even if the parent company is located outside of the EU. The ELD applies to all businesses,
More informationThis form has two parts: PART 1: WORK IN ONE COUNTRY and PART II: WORK IN TWO OR MORE COUNTRIES.
Udbetaling Danmark July 2013 International Social Security APPLICATION FORM FOR WORK WITHIN THE EEA AND SWITZERLAND cf. EC REGULATION 883/2004 working in the EEA and/or Switzerland THE FORM SHOULD BE ACCOMPANIED
More informationThe Quality System for Drugs in Germany
The Quality System for Drugs in Germany Prof. Dr. Harald G. Schweim Head of Department for Drug Regulatory Affairs Institute for Pharmacy, University of Bonn Former President of the German Federal Institute
More informationReport on Government Information Requests
Report on Government Information Requests January - June, Apple takes our commitment to protecting your data very seriously and we work incredibly hard to deliver the most secure hardware, software and
More informationAUDIT PROGRAMME. Guide to the design of internal quality assurance systems in higher education. Document 01 V. 1.0-21/06/07
AUDIT PROGRAMME Guide to the design of internal quality assurance systems in higher education Document 01 V. 1.0-21/06/07 INDEX FOREWORD FUNDAMENTALS OF DESIGNING INTERNAL QUALITY ASSURANCE SYSTEMS 1.-
More informationPUBLIC & PRIVATE HEALTH CARE IN CANADA
PUBLIC & PRIVATE HEALTH CARE IN CANADA by Norma Kozhaya, Ph.D. Economist, Montreal Economic Institute before the Canadian Pension & Benefits Institute Winnipeg - June 15, 2007 Possible private contribution
More informationERASMUS+ MASTER LOANS
ERASMUS+ MASTER LOANS Erasmus+ Master Loan: opening up access to more affordable lending for cross-border studies The Erasmus+ programme makes it possible for students who want to take a full Master's-level
More informationREPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS
EUROPEAN COMMISSION Brussels, 27.11.2013 COM(2013) 830 final REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS
More informationPanel: How broadband policy can contribute to deploy secured and universal broadband access. Presentation:
Panel: How broadband policy can contribute to deploy secured and universal broadband access Presentation: Initiatives to deploy broadband access in Europe Erik BOHLIN Chalmers University of Technology,
More informationFirst estimate for 2014 Euro area international trade in goods surplus 194.8 bn 24.2 bn surplus for EU28
30/2015-16 February 2015 First estimate for 2014 Euro area international trade in goods surplus 194.8 bn 24.2 bn surplus for EU28 The first estimate for the euro area 1 (EA18) trade in goods balance with
More informationIntroduction. Fields marked with * are mandatory.
Questionnaires on introducing the European Professional Card for nurses, doctors, pharmacists, physiotherapists, engineers, mountain guides and estate agents(to competent authorities and other interested
More informationTOYOTA I_SITE More than fleet management
EMPOWERING YOUR BUSINESS TOYOTA I_SITE More than fleet management www.toyota-forklifts.eu TOYOTA I_SITE More than fleet management Toyota I_Site is a unique combination of technology, information, expertise
More informationUNCITRAL legislative standards on electronic communications and electronic signatures: an introduction
legislative standards on electronic communications and electronic signatures: an introduction Luca Castellani Legal Officer secretariat International harmonization of e-commerce law Model Law on Electronic
More informationInformation on insurance tax and fire protection tax for EU/EEA insurers
Information on insurance tax and fire protection tax for EU/EEA insurers I. General This leaflet is intended for all insurers and authorised agents located in the EU/EEA area who are established outside
More informationA critical review of the current. marketing authorisation transfer procedure. in Europe
A critical review of the current marketing authorisation transfer procedure in Europe Wissenschaftliche Prüfungsarbeit zur Erlangung des Titels Master of Drug Regulatory Affairs der Mathematisch-Naturwissenschaftlichen
More informationLabour Force Survey 2014 Almost 10 million part-time workers in the EU would have preferred to work more Two-thirds were women
75/2015-27 April 2015 Labour Force Survey 2014 Almost 10 million part-time workers in the EU would have preferred to work more Two-thirds were women Among the 44.1 million persons in the European Union
More informationRecent Updates on European Requirements and what QPs are expected to do
Recent Updates on European Requirements and what QPs are expected to do QP Forum 28/29 November 2013, Lisbon Dr. Bernd Renger Modified: Georg Goestl 1 Written Conformation for API-Import Actual Status
More informationThe EFPIA Disclosure Code: Your Questions Answered
The EFPIA Disclosure Code: Your Questions Answered Working together: why do the pharmaceutical industry and healthcare professionals work together? 1 Why does industry pay health professionals to provide
More informationCar tax refund on export
Car tax customer bulletin 13 Car tax refund on export www.tulli.fi 1 January 2015 Replaces the bulletin from August 2014 Car tax refund on export This bulletin applies to getting refund on export if a
More informationSMEs and Operators from Developing Countries. Micro-Enterprises Standard
Article 9(4) of Regulation (EC) No 66/2010 of the an Parliament and of the Council of 25 November 2009 on the EU Ecolabel requires the EU Ecolabel Competent Bodies to which an application is made to charge
More informationPORTABILITY OF SOCIAL SECURITY AND HEALTH CARE BENEFITS IN ITALY
PORTABILITY OF SOCIAL SECURITY AND HEALTH CARE BENEFITS IN ITALY Johanna Avato Human Development Network Social Protection and Labor The World Bank Background study March 2008 The Italian Social Security
More informationINNOBAROMETER 2015 - THE INNOVATION TRENDS AT EU ENTERPRISES
Eurobarometer INNOBAROMETER 2015 - THE INNOVATION TRENDS AT EU ENTERPRISES REPORT Fieldwork: February 2015 Publication: September 2015 This survey has been requested by the European Commission, Directorate-General
More informationTPI: Traffic Psychology International on a common European curriculum for postgraduate education in traffic psychology
TPI: Traffic Psychology International on a common European curriculum for postgraduate education in traffic psychology Sucha, M.*, Sramkova, L.** DeVol, D.* * TPI - Traffic Psychology International **
More informationPrinciples for application of international reference pricing systems
Principles for application of international reference pricing systems International reference pricing (IRP) is a widely used element of price regulation in the vast majority of EU and EFTA countries. While
More informationIn May and July 2014 UK Visas and Immigration (UKVI) introduced changes to the right to work checks employers are required to carry out.
Summary of changes - August 2014 In May and July 2014 UK Visas and Immigration (UKVI) introduced changes to the right to work checks employers are required to carry out. In light of the recent changes,
More informationAlcohol interlocks: towards a European approach for the fight against drinkdriving
Ilyas Daoud Project Manager European Transport Safety Council Alcohol interlocks: towards a European approach for the fight against drinkdriving European Commission Representation in Poland Warsaw, 26
More informationWorld Leasing Yearbook 2016
Brochure More information from http://www.researchandmarkets.com/reports/3687603/ World Leasing Yearbook 2016 Description: The 2016 edition provides valuable reference data for all players in the field,
More informationNEW PASSENGER CAR REGISTRATIONS BY ALTERNATIVE FUEL TYPE IN THE EUROPEAN UNION 1 Quarter 4 2015
NEW PASSENGER CAR REGISTRATIONS BY ALTERNATIVE FUEL TYPE IN THE Quarter 4 2015 Alternative fuel vehicle (AFV) registrations: +20.0% in 2015; +21.1% in Q4 In the fourth quarter of 2015, total alternative
More informationAbout us. As our customer you will be able to take advantage of the following benefits: One Provider. Flexible Billing. Our Portal.
About us At RoamingExpert we specialise in mobile roaming tariffs which are tailored to the specific needs of the yachting industry. Our unique offering generates significant savings when compared to standard
More informationEuropean Research Council
ERC Starting Grant Outcome: Indicative statistics Reproduction is authorised provided the source ERC is acknowledged ERCEA/JH. ERC Starting Grant: call Submitted and selected proposals by domain Submitted
More informationEBA REPORT ON THE BENCHMARKING OF DIVERSITY PRACTICES. EBA-Op-2016-10 08 July 2016
EBA REPORT ON THE BENCHMARKING OF DIVERSITY PRACTICES EBA-Op-2016-10 08 July 2016 BENCHMARKING OF DIVERSITY PRACTICES AT THE EU LEVEL Benchmarking of diversity practices at the European Union level List
More informationDrink Driving in Europe
Safe & Sober: Reducing deaths and injuries from drink driving Copenhagen, 27 January 2010 Drink Driving in Europe Vojtech EKSLER Policy analyst Introduction to ETSC A science-based approach to road safety
More informationPROJECT: EURO-AUDITS THE EUROPEAN ROAD SAFETY AUDITOR TRAINING SYLLABUS APPENDIX E SURVEY RESULTS. October 2007
PROJECT: EURO-AUDITS THE EUROPEAN ROAD SAFETY AUDITOR TRAINING SYLLABUS APPENDIX E SURVEY RESULTS October 2007 A European Commission co-funded project Appendix E Survey Results Contents: Survey Results
More information168/2014-4 November 2014. At risk of poverty or social exclusion 2 rate in the EU28, 2008-2013 (% of total population)
168/2014-4 November 2014 At risk of poverty or social exclusion in the EU28 More than 120 million persons at risk of poverty or social exclusion in 2013 Almost 1 out of every 4 persons in the EU in this
More informationCOMMUNICATION FROM THE COMMISSION
EUROPEAN COMMISSION Brussels, 17.9.2014 C(2014) 6767 final COMMUNICATION FROM THE COMMISSION Updating of data used to calculate lump sum and penalty payments to be proposed by the Commission to the Court
More informationImplementing the cooperation mechanisms of the RES directive current status and open questions
Implementing the cooperation mechanisms of the RES directive current status and open questions Corinna Klessmann, Ecofys Germany RE-SHAPING Workshop, Vilnius, 16.05.2011 Supported by Intelligent Energy
More informationAnnual report 2009: the state of the drugs problem in Europe
Annual report 2009: the state of the drugs problem in Europe International Conference: New trends in drug use: facts and solutions, Parliament of the Republic of Vilnius - 5 November 2009 Dagmar Hedrich
More informationHigher education institutions as places to integrate individual lifelong learning strategies
Higher education institutions as places to integrate individual lifelong learning strategies Andrzej Krasniewski Warsaw University of Technology Bologna Expert QUALIFICATIONS FRAMEWORKS AS INSTRUMENTS
More informationProduct name Strength Pharmaceutical form. 100/6 micrograms per actuation. Formodual 100/6 Mikrogramm/Sprüh stoß, Druckgasinhalation, Lösung
Annex I List of the names, pharmaceutical, strength of the medicinal products, route of, marketing authorisation holders in the member states 1 Belgium Bulgaria Cyprus Denmark Estonia Finland 100/6 Mikrogramm/Sprüh
More information