QUESTIONS AND ANSWERS ABOUT THE EDQM ACTIVITIES

Size: px
Start display at page:

Download "QUESTIONS AND ANSWERS ABOUT THE EDQM ACTIVITIES"

Transcription

1 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 dispensing of medicines by pharmacists. Today, pharmacopoeias play a major role in the regulatory process and the control of active pharmaceutical ingredients (APIs), excipients and drug products and are used by industrial manufacturers, official medicines control laboratories and regulatory authorities. Pharmacopoeias provide public standards, specifications and test methods that are used by independent analysts for quality control. Today more than 80% of APIs used for the production of medicines for the European market come from outside Europe. Harmonised and state-of-the-art European quality standards are crucial to ensure the quality of medicines in this globalised setting. Why the European Pharmacopoeia is beneficial to all The European Pharmacopoeia is used during the life-cycle of a medicine: development, production and commercialisation. It harmonises the quality standards for active pharmaceutical ingredients (APIs), excipients and drug products, which, in their original state or in the form of pharmaceutical preparations, are of general interest and importance to the peoples of Europe, thus contributing to the safe use of medicines. It is constantly evolving either to respond rapidly to new risks to public health (eg: heparin crisis, new safety issues) or to respond to technical and scientific development. It is one of Europe s success stories in the past 50 years, contributing to a harmonised understanding of pharmaceutical quality and as a consequence benefiting all of us whenever we take our medicines Dr Jean Louis Robert, Chair of the European Pharmacopoeia Commission (April 2014). Medicines, Public Health and Media workshop 18 November 2014 Page 1

2 An indispensable reference for the regulatory authorities According to our mission we see ourselves as a national competent authority acting as a partner in the European network and promoting our values, namely being responsible, objective, competent and European. The European Pharmacopoeia serves as a fundamental compendium of quality standards for active substances and excipients; it is appreciated world-wide. The Certification procedure, to which a great many Austrian quality assessors contribute on a routine basis, can be considered as one of the most outstanding work-sharing projects in the field of medicines, ensuring excellent quality of assessment using resources efficiently and thus making a major contribution to public health DI Dr Christa Wirthumer-Hoche, Head of the Austrian Medicines and Medical Devices Agency (AGES) April Who was at the origin of a European Pharmacopoeia? In July 1964, eight countries (Belgium, France, Germany, Italy, Luxembourg, the Netherlands, Switzerland and the United Kingdom) signed the Council of Europe s Convention on the Elaboration of a European Pharmacopoeia. For the first time in their history they undertook to harmonise their national pharmacopoeias and replace their national rules with requirements. The harmonisation of national pharmacopoeias was the first step towards a European regulatory framework for medicines, which today applies to a medicine throughout its development and marketing and sale. What is the exact scope and influence of the European Pharmacopoeia? Today, thirty-seven European countries and the European Union, which in 1994 became a full member alongside its member states, have ratified the Convention, making this instrument's standards legally binding on their territories. The European Pharmacopoeia is also used as a reference by many other countries, both European and non-european. In addition, the European Pharmacopoeia has a growing number of observers, currently comprising 25 countries from all continents, the World Health Organization and the TFDA, and their participation in its scientific work bears witness to its importance and world-wide influence. Observers contribute to the work of the European Pharmacopoeia Commission by participating in scientific discussions but they do not participate in decisions. They may also choose to implement the standards of the European Pharmacopoeia, in full or in part, on their respective territories. This shared success puts Europe at the forefront of public health protection in the pharmaceutical sector. It is an outcome that could not have been achieved without the support of the member Medicines, Public Health and Media workshop 18 November 2014 Page 2

3 countries' national authorities and experts from a wide variety of scientific fields. Health authorities, universities, scientific institutes and industry participate in the work of the European Pharmacopoeia. Thus, for 50 years the European Pharmacopoeia has contributed to the basic human right of access to good quality medicines and healthcare and the promotion and protection of human and animal health. Over these decades, national pharmacopoeias have collaborated and pooled resources to build together a European pharmacopoeia which in 2014 consists of 2600 standard-setting texts published in its 8th Edition. What are the objectives of the European Pharmacopoeia? The European Pharmacopoeia has the objective of preparing quality standards (monographs) for medicines for human or veterinary use and the substances used in their production. The European Pharmacopoeia does not only have to ensure that its standards and test methods are robust and validated but also that they remain state-of-the-art. In addition, it has to respond rapidly to new risks to public health (eg heparin crisis, adverse thromboembolic effects of immunoglobulins etc) by elaborating new methods of analysis and tests and setting new specifications. What are the links between the European Pharmacopoeia and the European Directorate for the Quality of Medicines and HealthCare (EDQM)? The EDQM serves as the technical secretariat to the European Pharmacopoeia Commission. In addition the EDQM is in charge of establishing European Pharmacopoeia reference standards or preparations, which are needed to carry out the tests described in the monographs; The EDQM is also responsible for establishing alternatives to in vivo methods currently prescribed in the European Pharmacopoeia in order to reduce the use of animals (under the Biological Standardisation Programme financed in partnership with the European Commission); Medicines, Public Health and Media workshop 18 November 2014 Page 3

4 In addition the EDQM regularly organises conferences on new scientific and technical subjects, as well as seminars and training sessions on subjects related to the European Pharmacopoeia. What is the role of the European Pharmacopoeia in the pharmaceutical legislation? The European Pharmacopoeia is at the heart of the quality dossier required by European Pharmaceutical legislation, whatever the product's origins, method of production or type. From a simple tablet taken with a glass of water to the most complex types of formulations, all medicines put on the European market must comply with its quality specifications. Quality standards are vital instruments in the context of marketing authorisation and market surveillance; they facilitate access to good quality medicines throughout Europe and beyond. The Convention on the elaboration of a European Pharmacopoeia provides the legal framework for the European Pharmacopoeia and establishes its obligatory nature. The countries that ratify the Convention undertake to contribute to a common pharmacopoeia and to take the necessary measures to ensure that the European Pharmacopoeia texts become the official standards applicable within their respective territories. In addition, the European Pharmacopoeia standards are implemented through Community legislation (directives 2004/28/EC and 2003/63/EC) throughout the countries of the European Economic Area. Therefore consumers and patients can be assured that the medicine they receive, no matter where it was dispensed in Europe, its brand or type, will be safe and of high quality. What are the challenges ahead for the European Pharmacopoeia? Although much of the work on harmonising is almost complete, the quality standards (monographs) need to be continually revised and adopted to keep pace with the changes in the marketplace and scientific advances. There is a continuous need to update monographs, taking account of new developments and requirements triggered by scientific and technical evolutions (e.g. new molecules, new therapies), developments in the regulatory environment (e.g. guidelines like ICH, REACH), increased demand for generic and biosimilar products (e.g. new sources), new risks to public health (e.g. genotoxic impurities, TSE, contamination/falsification (heparins)) and developments in manufacturing and globalisation (e.g. continuous manufacturing, changed routes of synthesis) To remain state-of-the-art, the European Pharmacopoeia has a continuous process for adding and revising quality specifications (in 2014, the 8th Edition of the European Pharmacopoeia comprised over 2600 monographs and general chapters). Globalisation and expansions in international trade present further challenges as there is a growing need to develop global quality standards. Harmonisation among the world s three major pharmacopoeias, the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Medicines, Public Health and Media workshop 18 November 2014 Page 4

5 Pharmacopoeia, is currently an important and challenging task, as these standards are a vital instrument in the registration, market surveillance and free movement and trade of medicines among as many countries as possible. This growth in trade also makes it necessary to extend scientific relations and share expertise with emerging countries such as China, India and Brazil, so that their exports to Europe comply with the strict requirements of the European Pharmacopoeia. What is the origin of the EDQM? The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964) and was established as the Technical Secretariat to the European Pharmacopoeia Commission. Since then the EDQM has been entrusted with additional activities. To support the EDQM member states volunteer not only the services of experts in pharmaceutical sciences and access to equipment in national medicines control laboratories but also the services of experts in blood transfusion, organ transplantation, pharmaceuticals and pharmaceutical care or consumer protection, as well as those involved in assessments and inspections in the context of the certification of suitability procedure. The unwavering support from its member states is one of the factors in the success of the EDQM, enabling it to respond to the needs and realities of public health in Europe and beyond. What is the impact of the European Pharmacopoeia and the EDQM for an Official Medicines Control Laboratory? Defining the quality requirements and exchanging information between laboratories is essential for the success of the surveillance and the control of medicinal products and their ingredients. With the Pharmacopoeia, the EDQM provides the quality requirements and with the OMCL Network, it provides a platform to exchange information on methods and results. Both make my life easier Dr Philippe Girard, Head of Division OMCL (Laboratory), Swissmedic, Switzerland (April 2014) What are the tasks of the Network of Official Medicines Control Laboratories at European level? The network plays an essential role in the organisation of independent quality control testing; it ensures a high degree of control, avoids duplication of work by several countries and allows collaboration between States and facilitates access to state-of-the-art technology and effective analytical procedures. It is a perfect example of work-sharing between member States. Medicines, Public Health and Media workshop 18 November 2014 Page 5

6 2014: 67 official laboratories from 33 countries collaborate in a network, with financial contributions from the European Commission. The added value of the Certification of suitability procedure The Certification of suitability to the European Pharmacopoeia monographs procedure was created to ensure the quality of different sources of pharmaceutical substances in the context of globalisation, while respecting requirements for public health. It includes centralised assessment of applications describing the manufacture and quality control of substances for pharmaceutical use, for the benefit of the regulatory authorities and industry. Its corollary, a programme of inspection of manufacturing sites world-wide, supported by member States, is now an integral part of the procedure. The procedure: - certifies that the quality of substances used in the production of pharmaceutical products is ensured and that these substances comply with the European Pharmacopoeia and therefore with the requirements of the relevant EU legislation - facilitates the management of marketing authorisation applications for medicinal products - ensures work-sharing between licensing authorities and optimises the use of their resources - contributes to work-sharing between inspectorates and optimises the use of scarce resources through close collaboration with European and non-european authorities. The certification procedure provides valuable information on the quality of substances on the world market, which makes it possible to keep the European Pharmacopoeia constantly up to date. What were the EDQM biggest challenges over the last decades? Over the last 50 years, the European Pharmacopoeia and its Secretariat have extended their scope and grown substantially. The Secretariat has become the EDQM, and its portfolio of activities have resulted in what can be considered a true success story in work-sharing and making best use of scarce resources for the benefit of patients. Due to these successes and the experience acquired in international collaboration, the EDQM has been entrusted by the Committee of Ministers of the Council of Europe with additional missions since 2007 so that it is now also responsible for areas activities in the field of blood transfusion, transplantation of organs, cells and tissues, pharmaceuticals and pharmaceutical care and consumer health protection. Medicines, Public Health and Media workshop 18 November 2014 Page 6

7 However, where the quality, efficacy and safety of medicines are concerned, much remains to be done to protect patients health, keep abreast of scientific and therapeutic developments and ensure optimum use of existing resources. This 50th anniversary is an excellent opportunity to thank the member States for their manifold contributions and urge them to continue their collective commitment to public health protection within an intergovernmental paradigm that has proved its worth. Medicines, Public Health and Media workshop 18 November 2014 Page 7

EDQM Certificates of Suitability: Cooperation Among Inspectorates in Europe And Beyond

EDQM Certificates of Suitability: Cooperation Among Inspectorates in Europe And Beyond 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

More information

The European Pharmacopoeia and certificates of suitability (CEP)

The European Pharmacopoeia and certificates of suitability (CEP) The European Pharmacopoeia and certificates of suitability (CEP) Your Logo Andrew McMath Ph.D. European Directorate for the Quality of Medicines (EDQM) Presented by: Andrew McMath Scientific Officer, EDQM

More information

Comparative analysis between the possible regulatory approaches to GMP compliance TITOLO PRESENTAZIONE

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 information

1. Name of pharmacopoeia

1. 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 information

The European regulatory system for medicines and the European Medicines Agency

The 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 information

The 9 th Edition of the Ph. Eur. & current hot topics

The 9 th Edition of the Ph. Eur. & current hot topics The 9 th Edition of the Ph. Eur. & current hot topics Japanese Pharmacopoiea 130 th Annivsersary Symposium 15 th September 2016 Toyko, Japan Dr Susanne KEITEL Director European Directorate for the Quality

More information

HMPWG in the view of the NCA

HMPWG in the view of the NCA EMEA Homeopathic Workshop Bundesinstitut für Arzneimittel London, 27.10.2006 HMPWG in the view of the NCA Objectives, Achievements, Roles and Responsibilities Werner Knöss Head of Division Complementary

More information

Work plan for GMP/GDP Inspectors Working Group for 2016

Work 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 information

Sterilised Water for Injections PL 08801/0057 UKPAR

Sterilised Water for Injections PL 08801/0057 UKPAR Sterilised Water for Injections PL 08801/0057 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 11 Summary of Product Characteristics Page 12 Patient

More information

The Management of Pharmaceuticals in the Environment (PIE) FAQ. Key questions and answers. Q: How do pharmaceuticals get into the environment?

The Management of Pharmaceuticals in the Environment (PIE) FAQ. Key questions and answers. Q: How do pharmaceuticals get into the environment? The Management of Pharmaceuticals in the Environment (PIE) FAQ Key questions and answers Q: How do pharmaceuticals get into the environment? A: Like many foods and supplements that are consumed by humans

More information

GMP Pharma BV. Netherlands

GMP Pharma BV. Netherlands GMP Pharma BV Netherlands Connecting the European & Indian Pharmaceutical, Biotechnology and Biopharmaceutical Industry for parallel growth and solicitation. About Us: GMP Pharma BV is a multisource organization

More information

Paracetamol 1000 mg Effervescent Tablets PL 31388/0005

Paracetamol 1000 mg Effervescent Tablets PL 31388/0005 Paracetamol 1000 mg Effervescent Tablets PL 31388/0005 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 12 Summary of Product Characteristics Page

More information

Working with ICH Quality Guidelines - the Canadian Perspective

Working with ICH Quality Guidelines - the Canadian Perspective Working with ICH Quality Guidelines the Canadian Perspective Krishnan Tirunellai, Ph. D. Bureau of Pharmaceutical Sciences Therapeutic Products Directorate Health Canada December 3, 2008 Outline Introduction

More information

Session 6: WHO Prequalification Programme. Key Process Steps WHO: Medicines UNFPA: Condoms and IUDs

Session 6: WHO Prequalification Programme. Key Process Steps WHO: Medicines UNFPA: Condoms and IUDs Session 6: WHO Prequalification Programme Key Process Steps WHO: Medicines UNFPA: Condoms and IUDs Session adapted from the WHO training workshop on prequalification and the WHO technical briefing seminar

More information

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)

Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1) 22 May 2014 EMA/CHMP/BWP/247713/2012 Committee for Medicinal Products for Human Use (CHMP) Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance:

More information

Safeguarding public health. The British Pharmacopoeia. M Vallender Acting Group Manager, BP & Laboratory Services

Safeguarding public health. The British Pharmacopoeia. M Vallender Acting Group Manager, BP & Laboratory Services The M Vallender Acting Group Manager, BP & Laboratory Services OUTLINE Introduction National Activity European and International Activity Future Slide 2 INTRODUCTION Medicines and Healthcare products Regulatory

More information

DEXAMETHASONE 0.5 MG TABLETS PL 17507/0052 TABLE OF CONTENTS

DEXAMETHASONE 0.5 MG TABLETS PL 17507/0052 TABLE OF CONTENTS DEXAMETHASONE 0.5 MG TABLETS PL 17507/0052 TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 11 Steps taken after authorisation summary Page 12 Summary of

More information

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP) NOTE FOR GUIDANCE ON PROCESS VALIDATION

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP) NOTE FOR GUIDANCE ON PROCESS VALIDATION The European Agency for the Evaluation of Medicinal Products London, 1 March 2001 CPMP/QWP/848/96 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP)

More information

Guideline on similar biological medicinal products

Guideline on similar biological medicinal products 23 October 2014 CHMP/437/04 Rev 1 Committee for Medicinal Products for Human Use (CHMP) Draft agreed by Biosimilar Medicinal Products Working Party and Biologics Working Party March 2013 Adopted by CHMP

More information

The United States Pharmacopeia

The United States Pharmacopeia INTERNATIONAL MEETING OF WORLD PHARMACOPOEIAS 29 February to 2 March 2012 The United States Pharmacopeia Angela G. Long, M.S. Senior Vice President, Global Alliances and Organizational Affairs Roger L.

More information

Manchester Pharmacy School. www.manchester.ac.uk/pharmacy

Manchester Pharmacy School. www.manchester.ac.uk/pharmacy Manchester Pharmacy School Postgraduate study from Continuous Professional Development (CPD), Certificate, Diploma to Masters (MSc) with flexible, modular learning. The University of Manchester has a proud

More information

New Frontiers in the Quality of Medicines

New Frontiers in the Quality of Medicines New Frontiers in the Quality of Medicines Workshop Building a partnership for the investigation of counterfeit medicines Moderators: Dr Konstantin Keller Prof. Hendrick J. de Jong EDQM International Conference

More information

TRANSATLANTIC TRADE AND INVESTMENT PARTNERSHIP

TRANSATLANTIC TRADE AND INVESTMENT PARTNERSHIP DISCLAIMER: The EU reserves the right to make subsequent modifications to this text and to complement its proposals at a later stage, by modifying, supplementing or withdrawing all, or any part, at any

More information

Harmonizing Change Control Processes Globally

Harmonizing 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 information

20 & 21 October 2005 Clinical trials Risk issues within a wider Europe. Adrien Collovray Marsh Life Science Conference 2005 Berlin, Germany

20 & 21 October 2005 Clinical trials Risk issues within a wider Europe. Adrien Collovray Marsh Life Science Conference 2005 Berlin, Germany 20 & 21 October 2005 Clinical trials Risk issues within a wider Europe Adrien Collovray Life Science Conference 2005 Berlin, Germany Clinical trials EC Directive on clinical trials Insurance Requirements

More information

PL 17871/0208 UKPAR TABLE OF CONTENTS

PL 17871/0208 UKPAR TABLE OF CONTENTS Fultium-D 3 3,200 IU Capsules PL 17871/0208 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 11 Summary of Product Characteristics Page 12 Patient

More information

The APIC Audit Programme

The APIC Audit Programme The APIC Audit Programme Standardised Cost APIC-certified GMP Compliance A Third Party Audit Programme for API Manufactureres An Initiative of APIC in co-operation with CONCEPT HEIDELBERG A sector group

More information

PHARMACEUTICAL REFERENCE STANDARDS

PHARMACEUTICAL REFERENCE STANDARDS PHARMACEUTICAL REFERENCE STANDARDS 11 th International Symposium organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe 3-4 September 2012, Strasbourg,

More information

Paediatric Use Marketing Authorisation (PUMA) from a National Competent Authority Point of View

Paediatric Use Marketing Authorisation (PUMA) from a National Competent Authority Point of View Paediatric Use Marketing Authorisation (PUMA) from a National Competent Authority Point of View DGRA Annual Congress 2006 Bonn, 10. May 2006 Dr. Susanne Keitel Content PUMA The Future Background Legislative

More information

Workshop: C. System. Implementation of ICH Q8, Q9, Q10

Workshop: C. System. Implementation of ICH Q8, Q9, Q10 Implementation of ICH Q8, Q9, Q10 Workshop: C Pharmaceutical Quality System International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Disclaimer

More information

SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT

SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT Guideline Title Specifications and Control Tests on the Finished Product Legislative basis Directive 75/318/EEC as amended Date of first adoption

More information

Public Assessment Report

Public Assessment Report Public Assessment Report Sodium Chloride 1 mmol/ml Oral Solution (sodium chloride) UK Licence No: PL 20346/0008 Viridian Pharma Ltd LAY SUMMARY Sodium Chloride 1 mmol/ml Oral Solution (sodium chloride)

More information

for the right question

for the right question Real-World & Late Phase Research The right approach for the right question >625 Real-World & Late Phase Programs with >96,000 sites and >810,000 patients in >100 countries since 2011 >180 patient registries

More information

Memantine hydrochloride 20 mg film-coated tablets PL 17907/0291

Memantine hydrochloride 20 mg film-coated tablets PL 17907/0291 Memantine hydrochloride 20 mg film-coated tablets PL 17907/0291 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 5 Steps Taken for Assessment Page 13 Summary of Product Characteristics

More information

No. 1 Choice for Europe s Leading Brands e-recruitment

No. 1 Choice for Europe s Leading Brands e-recruitment Recognised as a leader in e-recruitment software by: No. 1 Choice for Europe s Leading Brands e-recruitment StepStone is the world s leading provider of Total Talent Management solutions. Every day StepStone

More information

Importing pharmaceutical products to China

Importing pharmaceutical products to China Importing pharmaceutical products to China Imported pharmaceutical products need pre-market approval before entering the Chinese market Imported drugs for human use are required to obtain pre-market approval

More information

Qualified Persons in the Pharmaceutical Industry Code of Practice 2009, updated August 2015

Qualified Persons in the Pharmaceutical Industry Code of Practice 2009, updated August 2015 Qualified Persons in the Pharmaceutical Industry Code of Practice 2009, updated August 2015 *QP Code of Practice 2008 updated Aug15 Page 1 of 13 Code of Practice for Qualified Persons 1. INTRODUCTION 2.

More information

Overview. Health Science Authority. Implementation of ICH guideline in Singapore. Singapore s experience

Overview. Health Science Authority. Implementation of ICH guideline in Singapore. Singapore s experience ICH and Singapore Dr Christina Lim Deputy Group Director, Health Product Regulation Group Senior Advisor, International Collaboration Health Sciences Authority Singapore November 2008 Overview Health Science

More information

Excipients Facing Increased Scrutiny How to Use Secondary Reference Standards to Help Maintain Regulatory Compliance

Excipients Facing Increased Scrutiny How to Use Secondary Reference Standards to Help Maintain Regulatory Compliance Excipients Facing Increased Scrutiny How to Use Secondary Reference Standards to Help Maintain Regulatory Compliance by Tom Savage, NSF International Since 2008, when patient deaths were first linked to

More information

InVita D3 25,000 IU oral solution PL 24837/0039

InVita D3 25,000 IU oral solution PL 24837/0039 InVita D3 25,000 IU oral solution PL 24837/0039 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 5 Steps taken for assessment Page 12 Summary of Product Characteristics Page 13 Patient

More information

Considerations for veterinary scientific advice and marketing authorisations

Considerations for veterinary scientific advice and marketing authorisations Considerations for veterinary scientific advice and marketing authorisations Presented by: Mary O Grady Irish Medicines Board An agency of the European Union Veterinary scientific advice Veterinary marketing

More information

EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE

EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE EU DIRECTIVE ON GOOD CLINICAL PRACTICE IN CLINICAL TRIALS DH & MHRA BRIEFING NOTE Purpose 1. The Clinical Trials Directive 2001/20/EC heralds certain additional responsibilities for the Medicines and Healthcare

More information

well foresight studies opportunities for regenerative medicine in the netherlands royal netherlands academy of arts and sciences

well foresight studies opportunities for regenerative medicine in the netherlands royal netherlands academy of arts and sciences well underway opportunities for regenerative medicine in the netherlands royal netherlands academy of arts and sciences foresight studies 5. conclusions and recommendations Scientific research in regenerative

More information

EFPIA Principles for the Development of the EU Clinical Trials Portal and Database

EFPIA Principles for the Development of the EU Clinical Trials Portal and Database Position Paper EFPIA Principles for the Development of the EU Clinical Trials Portal and Database Executive summary EFPIA sees the implementation of the Clinical Trials Regulation 1 as an opportunity to

More information

FURTHER EXCELLENCE MARKET INTELLIGENCE MEDICAL DEVICES FIND THE FASTEST AND MOST RELIABLE ROUTE TO MARKET AUDITS, CERTIFICATION AND TRAINING

FURTHER EXCELLENCE MARKET INTELLIGENCE MEDICAL DEVICES FIND THE FASTEST AND MOST RELIABLE ROUTE TO MARKET AUDITS, CERTIFICATION AND TRAINING QUALITY RISK MANAGEMENT COMPETITIVE ADVANTAGE EXPERTISE FURTHER EXCELLENCE MARKET INTELLIGENCE REGULATORY COMPLIANCE SPEED TO MARKET PATIENT SAFETY MEDICAL DEVICES FIND THE FASTEST AND MOST RELIABLE ROUTE

More information

Official Journal of the European Union. (Acts whose publication is obligatory)

Official Journal of the European Union. (Acts whose publication is obligatory) 27.12.2006 L 378/1 I (Acts whose publication is obligatory) REGULATION (EC) No 1901/2006 OF THE EUROPEAN PARLIAMT AND OF THE COUNCIL of 12 December 2006 on medicinal products for paediatric use and amending

More information

1. The pharmaceutical industry Packaging design

1. The pharmaceutical industry Packaging design 1. The pharmaceutical industry The pharmaceutical industry aims to guarantee patient safety by producing a safe product which has been tested according to the highest standard of current scientific knowledge

More information

EFPIA Position Paper on REACH. Executive Summary. Position Paper. Draft Final. Author: EFPIA Date: October 2015 Version: Final

EFPIA Position Paper on REACH. Executive Summary. Position Paper. Draft Final. Author: EFPIA Date: October 2015 Version: Final Draft Final EFPIA Position Paper on REACH Author: EFPIA Date: October 2015 Version: Final Position Paper Executive Summary An increasing number of substances used in the pharmaceutical manufacturing process

More information

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. EudraLex. The Rules Governing Medicinal Products in the European Union

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL. EudraLex. The Rules Governing Medicinal Products in the European Union EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products- authorisations, European Medicines Agency Brussels, EudraLex The Rules Governing Medicinal

More information

Building a Serialization Compliance/Advocacy Management System. Lewis Kontnik, Director Global Product Protection Amgen Inc.

Building a Serialization Compliance/Advocacy Management System. Lewis Kontnik, Director Global Product Protection Amgen Inc. Building a Serialization Compliance/Advocacy Management System Lewis Kontnik, Director Global Product Protection Amgen Inc. (April 2013) About Amgen World s leading independent biotechnology company, with

More information

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY VERSION 7

EUROPEAN 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 information

THEME: PROMOTING GOOD PRACTICES IN DRUG POLICY DEVELOPMENT AND IMPLEMENTATION

THEME: PROMOTING GOOD PRACTICES IN DRUG POLICY DEVELOPMENT AND IMPLEMENTATION Page 1 AFRICAN UNION UNION AFRICAINE UNIÃO AFRICANA Addis Ababa, ETHIOPIA P. O. Box 3243 Telephone 251-11-5517 700 Fax 251-11-5517 844 website: www. africa-union.org 5 th SESSION OF THE AU CONFERENCE OF

More information

Introduction to ISO Identification of Medicinal Products, SPOR programme

Introduction to ISO Identification of Medicinal Products, SPOR programme 29 November 2016 EMA/732656/2015 Information Management Division Introduction to ISO Identification of Medicinal Products, SPOR programme 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone

More information

An information platform that delivers clinical studies better, faster, safer and more cost effectively

An information platform that delivers clinical studies better, faster, safer and more cost effectively An information platform that delivers clinical studies better, faster, safer and more cost effectively Powering Process & Performance Proactively manage study start-up and execution Risk profile new sites

More information

The Quality System for Drugs in Germany

The 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 information

BIO-PARTNERING EUROPE EVENT SPEECH PAOLA TESTORI COGGI DIRECTOR GENERAL FOR HEALTH AND CONSUMERS EUROPEAN COMMISSION

BIO-PARTNERING EUROPE EVENT SPEECH PAOLA TESTORI COGGI DIRECTOR GENERAL FOR HEALTH AND CONSUMERS EUROPEAN COMMISSION EUROPABIO BIO-PARTNERING EUROPE EVENT TUESDAY 9 OCTOBER 2012 9.10 9.20 HRS SPEECH BY PAOLA TESTORI COGGI DIRECTOR GENERAL FOR HEALTH AND CONSUMERS EUROPEAN COMMISSION I am pleased to have the opportunity

More information

Clinical trials preclinical requirements. Clinical trials - legislation

Clinical trials preclinical requirements. Clinical trials - legislation Clinical trials preclinical requirements Mikael Andersson, PhD Senior Expert Medical Products Agency, Sweden Tallinn 9/10 2009 Clinical trials - legislation Directive 2001/20/EC Clinical trial directive

More information

REGULATION (EEC) No 2309/93

REGULATION (EEC) No 2309/93 REGULATION (EEC) No 2309/93 Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use

More information

Lifecycle CMC Management: ICH Q12 Progress to date

Lifecycle CMC Management: ICH Q12 Progress to date Lifecycle CMC Management: ICH Q12 Progress to date BWP/QWP/GMDP IWG Industry European workshop 28-29 October 2015 Jean-Louis ROBERT (EU) Graham Cook (EFPIA) Please take note The following slides represent

More information

CLINICAL TRIALS WITH MEDICINES IN EUROPE

CLINICAL TRIALS WITH MEDICINES IN EUROPE CLINICAL TRIALS WITH MEDICINES IN EUROPE REGULATORY FRAMEWORK FOR CLINICAL TRIALS WITH MEDICINES IN EUROPE The pharmaceutical industry is the most highly regulated sector in Europe. The Commission has

More information

ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION

ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 038-1 26 March 2012 AIDE-MEMOIRE ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION PIC/S March 2012 Reproduction

More information

EUCERD RECOMMENDATIONS QUALITY CRITERIA FOR CENTRES OF EXPERTISE FOR RARE DISEASES IN MEMBER STATES

EUCERD RECOMMENDATIONS QUALITY CRITERIA FOR CENTRES OF EXPERTISE FOR RARE DISEASES IN MEMBER STATES EUCERD RECOMMENDATIONS QUALITY CRITERIA FOR CENTRES OF EXPERTISE FOR RARE DISEASES IN MEMBER STATES 24 OCTOBER 2011 INTRODUCTION 1. THE EUROPEAN CONTEXT Centres of expertise (CE) and European Reference

More information

Biostatistics in Medical Product Regulation: Introduction. Simon Day, PhD Johns Hopkins University

Biostatistics in Medical Product Regulation: Introduction. Simon Day, PhD Johns Hopkins University This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike License. Your use of this material constitutes acceptance of that license and the conditions of use of materials on this

More information

Donepezil hydrochloride 10 mg film-coated tablets PL 19156/0130

Donepezil hydrochloride 10 mg film-coated tablets PL 19156/0130 Donepezil hydrochloride 10 mg film-coated tablets PL 19156/0130 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 4 Steps Taken for Assessment Page 12 Summary of Product Characteristics

More information

Guideline on dossier requirements for Type IA and IB notifications

Guideline 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 information

Introduction to Q10 Pharmaceutical Quality System

Introduction to Q10 Pharmaceutical Quality System ICH-GCG Asean Training Workshop on ICH Guidelines Q8,Q9 and Q10 (New Paradigm) Introduction to Q10 Pharmaceutical Quality System Georges FRANCE, Q- IWG Kuala Lumpur, Malaysia 26-28 July 2010 International

More information

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Ref. Ares(2011)1044649-03/10/2011 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Pharmaceuticals SANCO/D3/RSR/iv(2011)ddg1.d3. 1137738 Update 1 October 2011 HANDLING

More information

LABORATORY OUTSOURCING

LABORATORY OUTSOURCING June 2009 LABORATORY OUTSOURCING Intertek s EVP of Analytical Services, Dr. Andrew Swift, discusses laboratory outsourcing and explains how dedicated analytical service providers are stepping up to support

More information

Draft guidance for registered pharmacies preparing unlicensed medicines

Draft guidance for registered pharmacies preparing unlicensed medicines Draft guidance for registered pharmacies preparing unlicensed medicines January 2014 1 The General Pharmaceutical Council is the regulator for pharmacists, pharmacy technicians and registered pharmacies

More information

Regulatory Affairs Graduate & Postgraduate Program. Novartis Pharma AG Novartis Animal Health AG

Regulatory Affairs Graduate & Postgraduate Program. Novartis Pharma AG Novartis Animal Health AG Regulatory Affairs Graduate Postgraduate Program Novartis Pharma AG Novartis Animal Health AG The Regulatory Affairs (RA) Graduate Program is an opportunity to discover the global functions of Drug Regulatory

More information

Recent Updates on European Requirements and what QPs are expected to do

Recent 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 information

Excipient Certification: Schemes and Auditable Standards - the role in Supplier Qualification

Excipient Certification: Schemes and Auditable Standards - the role in Supplier Qualification Excipient Certification: Schemes and Auditable Standards - the role in Supplier Qualification European Compliance Academy Hamburg 26th 27th April 2010 Dr Iain Moore Certification Committee IPEC Europe

More information

EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL VERSION 4.1

EUROPEAN 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 information

GMP/Regulatory Environment in the

GMP/Regulatory Environment in the GMP/Regulatory Environment in the Latin America Irene Ortiz Barreal, Pharm. D., R.Ph. Pfizer International Affiliate Quality Compliance Regional Leader Latin America/Caribbean April 14, 2011 Discloser

More information

Medicines and Healthcare products Regulatory Agency

Medicines and Healthcare products Regulatory Agency Medicines and Healthcare products Regulatory Agency 11 April 2016 Update on progress with the Joint Patient Safety and Vigilance Strategy Purpose: This paper provides the Board with an update on the Joint

More information

Workshop B Control Strategy

Workshop B Control Strategy ICH-GCG ASEAN Workshop B Control Strategy Jean-Louis ROBERT, Ph.D. National Health Laboratory, Luxembourg Chair-person ICH IWG Q8, Q9, Q10 Kuala Lumpur, 26-28 July 2010 International Conference on Harmonisation

More information

Compilation of Community Procedures on Inspections and Exchange of Information

Compilation 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 information

TOYOTA I_SITE More than fleet management

TOYOTA 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 information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS European Medicines Agency Evaluation of Medicines for Human Use CHMP/437/04 London, 30 October 2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS

More information

ICH guideline Q10 on pharmaceutical quality system

ICH guideline Q10 on pharmaceutical quality system September 2015 EMA/CHMP/ICH/214732/2007 Committee for Human Medicinal Products Step 5 Transmission to CHMP May 2007 Transmission to interested parties May 2007 Deadline for comments November 2007 Final

More information

SADC GUIDELINES ON IMPORT AND EXPORT PROCEDURES FOR PHARMACEUTICAL PRODUCTS

SADC GUIDELINES ON IMPORT AND EXPORT PROCEDURES FOR PHARMACEUTICAL PRODUCTS SADC GUIDELINES ON IMPORT AND EXPORT PROCEDURES FOR PHARMACEUTICAL PRODUCTS June 2006 1 INTRODUCTION Public health concerns demand that the manufacture of pharmaceutical products and their subsequent handling

More information

Biobanking Pluripotent Stem Cell Lines: UK and EU regulations Glyn Stacey, UK Stem Cell Bank, NIBSC

Biobanking Pluripotent Stem Cell Lines: UK and EU regulations Glyn Stacey, UK Stem Cell Bank, NIBSC Biobanking Pluripotent Stem Cell Lines: UK and EU regulations Glyn Stacey, UK Stem Cell Bank, NIBSC ISCT Conference, New Zealand, April 2013 April 1 st 2013 NIBSC will become part of the Medicines and

More information

Changes to the Pharmaceutical/Quality part of the Dossier

Changes to the Pharmaceutical/Quality part of the Dossier New Classification Guideline Changes to the Pharmaceutical/Quality part of the Dossier Dr Keith Pugh DIA London October 2009 The views and opinions expressed in the following PowerPoint slides are those

More information

Career opportunities for Ph.D. s in the pharmaceutical industry. Martin C. Michel, MD, MAE, FBPharmacolS

Career opportunities for Ph.D. s in the pharmaceutical industry. Martin C. Michel, MD, MAE, FBPharmacolS Career opportunities for Ph.D. s in the pharmaceutical industry Martin C. Michel, MD, MAE, FBPharmacolS Disclaimer This presentation is intended to inform about career opportunities in the pharmaceutical

More information

Guide to Fees for Veterinary Products

Guide to Fees for Veterinary Products Guide to Fees for Veterinary Products FIN-G0003-14 04 FEBRUARY 2016 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only. CONTENTS ABBREVIATIONS

More information

Mutual 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? 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 information

THE WHAT AND WHY OF REGULATORY OUTSOURCING

THE WHAT AND WHY OF REGULATORY OUTSOURCING WHITE PAPER THE WHAT AND WHY OF REGULATORY OUTSOURCING Today s evolving healthcare landscape poses unprecedented challenges to biopharmaceutical companies. Consolidation, budget cuts, restructuring, globalization

More information

opinion piece Eight Simple Steps to Effective Software Asset Management

opinion piece Eight Simple Steps to Effective Software Asset Management opinion piece Eight Simple Steps to Effective Software Asset Management Contents Step 1: Collate your licence agreements 01 Step 2: Determine your actual licence position 01 Step 3: Understand your existing

More information

EXPERT REVIEW PANEL PROCEDURE: ADDITIONAL SUPPORT TO PROCUREMENT AGENCIES UNDER EXCEPTIONAL CIRCUMSTANCES

EXPERT REVIEW PANEL PROCEDURE: ADDITIONAL SUPPORT TO PROCUREMENT AGENCIES UNDER EXCEPTIONAL CIRCUMSTANCES EXPERT REVIEW PANEL PROCEDURE: ADDITIONAL SUPPORT TO PROCUREMENT AGENCIES UNDER EXCEPTIONAL CIRCUMSTANCES Introduction The WHO Prequalification of Medicines Programme (PQP) was established to provide UN

More information

12 April FZ. On Circulation of Medicines. Adopted by the State Duma March 24, 2010

12 April FZ. On Circulation of Medicines. Adopted by the State Duma March 24, 2010 12 April 2010 61-FZ On Circulation of Medicines Adopted by the State Duma March 24, 2010 (as amended by Federal Laws of July, 27 2010, 192-FZ; of October 11, 2010, No. 271-FZ, of November 29, No. 313-FZ,

More information

Thermo Scientific LIFECYCLE Asset & Service Management for Healthcare

Thermo Scientific LIFECYCLE Asset & Service Management for Healthcare Thermo Scientific LIFECYCLE Asset & Service Management for Healthcare HEALTHCARE SUPPLYSIDE SOLUTIONS Focused on your unique needs for managing assets, costs, and suppliers Part of Thermo Fisher Scientific

More information

AIFP Disclosure Code Frequently asked questions

AIFP Disclosure Code Frequently asked questions AIFP Disclosure Code Frequently asked questions Obsah Question No. 1: Which Transfers of Value should be disclosed in the aggregate and which ones individually?... 3 Question No. 2: What Transfers of Value

More information

The EFPIA Disclosure Code: Your Questions Answered

The 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 information

Part 3 Medical Officer (MO) Work Level Standards

Part 3 Medical Officer (MO) Work Level Standards Part 3 Medical Officer (MO) Work Level Standards MEDICAL OFFICER-CLASSES 1 6 GROUP STANDARD The work of positions in this group involves the application of professional medical knowledge and experience

More information

MINISTRY OF HEALTH ORDINANCE

MINISTRY OF HEALTH ORDINANCE MINISTRY OF HEALTH 1798 Pursuant to Article 74, paragraphs 2 and 3, Article 83, paragraph 5 and Article 89 of the Medicinal Products Act (Official Gazette 76/2013), the Minister of Health hereby issues

More information

OMCL Network of the Council of Europe QUALITY MANAGEMENT DOCUMENT

OMCL Network of the Council of Europe QUALITY MANAGEMENT DOCUMENT OMCL Network of the Council of Europe QUALITY MANAGEMENT DOCUMENT PA/PH/OMCL (14) 18 3R SUB-CONTRACTING OF TESTS Full document title and reference Guideline Sub-Contracting of Tests PA/PH/OMCL (14) 18

More information

PHARMACEUTICAL QUALITY SYSTEM Q10

PHARMACEUTICAL QUALITY SYSTEM Q10 INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE PHARMACEUTICAL QUALITY SYSTEM Q10 Current Step

More information

HOMEOPATHIC MEDICINAL PRODUCT WORKING GROUP (HMPWG) GUIDANCE ON MODULE 3 OF THE HOMEOPATHIC MEDICINAL PRODUCTS DOSSIER

HOMEOPATHIC MEDICINAL PRODUCT WORKING GROUP (HMPWG) GUIDANCE ON MODULE 3 OF THE HOMEOPATHIC MEDICINAL PRODUCTS DOSSIER HOMEOPATHIC MEDICINAL PRODUCT WORKING GROUP (HMPWG) GUIDANCE ON MODULE 3 OF THE HOMEOPATHIC MEDICINAL PRODUCTS DOSSIER DISCUSSION IN THE HMPWG 2003-2005 RELEASE FOR CONSULTATION December 2005 DEADLINE

More information

COUNCIL OF THE EUROPEAN UNION. Brussels, 7 October 2003 (OR. en) 12858/03 RECH 152 OC 589

COUNCIL OF THE EUROPEAN UNION. Brussels, 7 October 2003 (OR. en) 12858/03 RECH 152 OC 589 COUNCIL OF THE EUROPEAN UNION Brussels, 7 October 2003 (OR. en) 12858/03 RECH 152 OC 589 LEGISLATIVE ACTS AND OTHER INSTRUMENTS Subject : Council Decision on the signing of the Framework Agreement between

More information

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof;

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof; DIRECTIVE 65/65/EEC Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ L No 22 of

More information