Ensuring protection of public health and patients in member states: priorities, constraints, opportunities

Size: px
Start display at page:

Download "Ensuring protection of public health and patients in member states: priorities, constraints, opportunities"

Transcription

1 Ensuring protection of public health and patients in member states: priorities, constraints, opportunities Dr. Christa Wirthumer-Hoche AGES Austrian Medicines and Medical Devices Agency Vienna, Austria April 15, 2014 Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH

2 AGES - Our Vision Health for Humans, Animals and Plants 2

3 AGES Structure 1) 2) Division Food Security Food Safety Veterinary Medicine Public Health Austrian Medicine & Medical Devices Agency Radiation Protection Department Data, Statistics & Integrative Risk Assessment Knowledge Transfer & Applied Research 1) Austrian Federal Office for Food Safety 2) Austrian Federal Office for Safety in Healthcare 3

4 Austrian Medicines & Medical Devices Agency New structure of the Austrian Agency since 1st Dec Reorganisation 3 Instituts oreshaping for the future Life Cycle Management MRP/DCP/pure national Analytical and assessment focus on CP & PHV Inspection & Medical Devices - Strengthen communication 4

5 Austrian Medicines and Medical Devices Agency Vision We strive, within our areas of responsibility, to take a leading role among medicines agencies in Europe Mission We are the national competent authority for medicinal products and medical devices and a partner to competent authorities and agencies throughout Europe. 5

6 Processes of the AGES MEA in the Life-Cycle of Medicinal Products! therapeutic concept Scientific / Regulatory Advice Manufacturing Authorisation (GMP-Inspections) Assessment of Clinical Trials GLP- & GCP-Inspections Marketing Authorisation Suspension of Marketing Authorisation Variations / Renewals of Marketing Authorisation Variations of Manufacturing Authorisation Safety Signals & Risk Management periodic GMP-Inspections Market Surveillance Official Control Authority Batch Release 6

7 Scientific Advice AT No 3 in EU ranking ~ 20% of all procedures each year Source: EMA 7

8 Priorities for the Austrian Medicines Agency We ensure high-quality, safe and effective medicines for patients Availability/Supply of essential medicines Rapid market access for new/innovative medicinal products Pro-active information for patients and healthcare personal Good cooperation with NCAs, EMA, EDQM, Ministry, 8

9 European Network SK BE UK LT LU LV EMA MT NL GR PL CY PT AT CZ DE EC EE IT DK ES BG FR SI HU FI SE HR IE IT EDQM Christa Wirthumer-Hoche 9

10 European System We are not working in isolation - We are working within a Network!! Unique system 28 MS + 3 EEA (~ 44 national agencies) EMA EDQM EC Christa Wirthumer-Hoche 10

11 Authorisation system Licensing of medicinal products is stronlgy regulated Almost all legislation and requirements are based on harmonised EU rules Global harmonisation has advanced dramatically Christa Wirthumer-Hoche 11

12 EU Network Centralised activities Multinational non-centralised activities National activites The same resources at NCAs underpin all three! Worksharing is essential Christa Wirthumer-Hoche 12

13 Opportunities We as NCAs have to work together efficiently and use the same language and standards We as NCA cooperate and contribute in further various worksharing projects, e.g. MRP/DCP role of RMS (#7 in EU ranking) CP role of Rapporteur/Co-Rapporteur (#9 in EU ranking) EMA scientific advices (#3 in EU ranking) 13

14 Participation of AT as Rapporteur/ Co-Rapporteur in CP (source EMA) 14

15 MRP/DCP New applications FINALISED Procedures DCP

16 New applications 1 Jan 31 Dec

17 Why do we need worksharing? Duplicated assessment Divergent decisions Increased requirements Reduced human resources Increased workload (all parties) 17

18 An example for Worksharing Quality documentation for the Active Substance for a Medicinal Product Assessment team: Different locations, but mostly same assessors from NCAs Licensing authority ASMF EDQM CEP o ASMF-Worksharing: AT is Rapporteur of European ASMF number 00001, ASMF Worksharing project helps to save ressources on all sides (NCAs, EDQM and industry) and ensures harmonized and rapid assessment o AT- one of the most active EU-MS in the certification procedure

19 Opportunities We as NCAs have to work together efficiently and use the same language and standards We accept and promote use of CEPs CEP procedure helps to update Ph.Eur. monographs as a result of assessment We cooperate to constantly enhance quality of Ph. Eur. by participating in elaborating monographs 19

20 Contribution of AT to EDQM work CEP assessment 11 chemical assessors participated in CEP sessions corresponding to 84 assessment days 2 biological assessors participated in CEP sessions corresponding to 2 assessment days 1 chemical assessor is member of the chemical Technical Advisory Board (TAB - deals with technical or scientific questions raised by the assessors and prepares/discusses technical guidance documents) 1 chemical assessor is member of ad Hoc Committee (is involved in decision process regarding suspension/withdrawal/ restoration of CEPs) 20

21 Constraints Inspections, Q-defects Focus inspection ressources (worldwide), enhance global mutual recognition Increasing number of GMP inspections with negative outcome non-compliance reports (NCRs), suspensions/withdrawals of CEPs Shortages of essential medicinal products Falsification 21

22 Shortages of medicinal products The number of serious shortages in the EU is increasing Reason: - Manufacturing problems - Poor product quality (eg. impurities) - Lack of production capacity Problem: - National Competent Authorities may not have received all relevant information on time - When no proper alternative treatment is available in short term.

23 Quality of medicinal products Has to meet international standards of quality (eg. - Ph.Eur.) and to fulfill requirements Only products of good quality ensure proven safety and efficacy High quality ensures protection of public health and patients 23

24 Thank you for your kind attention! Questions? 24

VARIATIONS : IMPACT ON ADMINISTRATIVE BURDEN AND FEES. Rose-Marie Molina EMA Infoday London, 14th March 2014

VARIATIONS : IMPACT ON ADMINISTRATIVE BURDEN AND FEES. Rose-Marie Molina EMA Infoday London, 14th March 2014 Rose-Marie Molina EMA Infoday London, 14th March 2014 Before 1234/2008 Regulation, variation procedures in the European Union for industry was synonymous of: - Lack of visibility about timelines - Lack

More information

Blanka Hirschlerová. EDQM CEP conference Prague, Czech Republic

Blanka Hirschlerová. EDQM CEP conference Prague, Czech Republic 1 Experience with CEPs from a European regulatory authority perspective Blanka Hirschlerová EDQM CEP conference Prague, Czech Republic 2012 STATE INSTITUTE FOR DRUG CONTROL Agenda 2 Agenda Introduction

More information

DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT

DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT BASG - Federal Office for Safety in Health Care AGES - Austrian Agency for Health and Food Safety Traisengasse 5, A-1200 Vienna www.basg.gv.at DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT

More information

List of nationally authorised medicinal products

List of nationally authorised medicinal products 10 September 2015 EMA/677092/2015 Procedure Management and Committees Support Active substance: glatiramer Procedure no.: PSUSA/00001529/201411 30 Churchill Place Canary Wharf London E14 5EU United Kingdom

More information

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY. Brussels, Revision 1. Medicinal Products for Human Use

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY. Brussels, Revision 1. Medicinal Products for Human Use EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health systems, medical products and innovation Brussels, Revision 1 NOTICE TO APPLICANTS Medicinal Products for Human Use VOLUME 2B Presentation

More information

Public administration reforms and public sector performance in Central and Eastern Europe EU member states: in EU perspective

Public administration reforms and public sector performance in Central and Eastern Europe EU member states: in EU perspective Public administration reforms and public sector performance in Central and Eastern Europe EU member states: in EU perspective Prof. Ing. Juraj Nemec, CSc. Masaryk University, Czech Republic, Size of government

More information

Workshop for OIE national Focal Points for Veterinary Products November 2010, Johannesburg, South Africa. Presentation

Workshop for OIE national Focal Points for Veterinary Products November 2010, Johannesburg, South Africa. Presentation Dr. Anja Holm Chair of CVMP, EMA Danish Medicines Agency Copenhagen, DK - Denmark anh@dkma.dk Overview of existing structures relevant for Veterinary Products Regional Structures: Europe European Medicine

More information

Report from the CMD(h) meeting held on 17 th and 18 th March 2008

Report from the CMD(h) meeting held on 17 th and 18 th March 2008 Report from the CMD(h) meeting held on 17 th and 18 th March 2008 CMD(h)/EMEA Sub-Group on Paediatric Regulation Further to the line listings received for authorised medicinal products (including purely

More information

EDQM and European Pharmacopoeia: State-of-the-art Science for Tomorrow s Medicines

EDQM and European Pharmacopoeia: State-of-the-art Science for Tomorrow s Medicines EDQM and European Pharmacopoeia: State-of-the-art Science for Tomorrow s Medicines International Conference organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council

More information

Implementation Report on the patient safety Recommendation 2009/C 151/01. Healthcare Systems Unit DG SANCO

Implementation Report on the patient safety Recommendation 2009/C 151/01. Healthcare Systems Unit DG SANCO Implementation Report on the patient safety Recommendation 2009/C 151/01 Healthcare Systems Unit DG SANCO Published 15 November 2012 REPORT FROM THE COMMISSION TO THE COUNCIL on the basis of Member States'

More information

Meeting report, September 2005

Meeting report, September 2005 European Medicines Agency Post-authorisation Evaluation of Medicines for Human Use London, 24 October 2005 Doc. Ref. EMEA//322553/2005 COMMITTEE ON HERBAL MEDICINAL PRODUCTS () Meeting report, 19-20 September

More information

'SECTION B EU PARTY. The following abbreviations are used:

'SECTION B EU PARTY. The following abbreviations are used: 'SECTION B EU PARTY The following abbreviations are used: AT Austria BE Belgium BG Bulgaria CY Cyprus CZ Czech Republic DE Germany DK Denmark ES Spain EE Estonia EU European Union, including all its Member

More information

Results of the Survey addressed to the EU Member States about quantification of food waste and preventing Food waste Brussels,

Results of the Survey addressed to the EU Member States about quantification of food waste and preventing Food waste Brussels, Results of the Survey addressed to the EU Member States about quantification of food waste and preventing Food waste Brussels, 29.11.2016 Survey Number of addressed countries: 29 28 (EU Member States)

More information

Decentralised Procedure. Public Assessment Report. Memantin Orion 10/20 mg Filmtabletten. Memantine hydrochloride DE/H/3653/ /DC

Decentralised Procedure. Public Assessment Report. Memantin Orion 10/20 mg Filmtabletten. Memantine hydrochloride DE/H/3653/ /DC Decentralised Procedure Public Assessment Report Memantin Orion 10/20 mg Filmtabletten Memantine hydrochloride DE/H/3653/001-002/DC Applicant: Orion Corporation, Finland Reference Member State DE TABLE

More information

Pharmaceutical Pricing & Reimbursement Information. PPRI Project Co-ordination Sabine Vogler, Gesundheit Österreich GmbH

Pharmaceutical Pricing & Reimbursement Information. PPRI Project Co-ordination Sabine Vogler, Gesundheit Österreich GmbH PPRI - Comparative Analysis PPRI Project Co-ordination Sabine Vogler, Gesundheit Österreich GmbH PPRI Conference Vienna, 29 June 2007 PPRI Conference, Vienna, 29 June 2007 1 Comparative Analysis - Outline

More information

FOOD IRRADIATION within the EU

FOOD IRRADIATION within the EU FOOD IRRADIATION within the EU The EU Legislation and results of monitoring in the EU Dr S.COULON DG Health and Food Safety - Unit G4 (Food/Alert system and training) IAEA - Vienna 10-14 October 2014 Food

More information

Decentralised Procedure. RMS Day 210 Assessment Report OVERVIEW. Budenofalk 9 mg gastro-resistant granules (Budesonide) UK/H/2778/001/DC

Decentralised Procedure. RMS Day 210 Assessment Report OVERVIEW. Budenofalk 9 mg gastro-resistant granules (Budesonide) UK/H/2778/001/DC Decentralised Procedure RMS Day 210 Assessment Report OVERVIEW Budenofalk 9 mg gastro-resistant granules (Budesonide) UK/H/2778/001/DC Applicant: Dr. Falk Pharma GmbH Reference Member State UK Start of

More information

Decentralised Procedure. Public Assessment Report. Memantin AbZ 10 mg/20 mg Filmtabletten ; Starterpack

Decentralised Procedure. Public Assessment Report. Memantin AbZ 10 mg/20 mg Filmtabletten ; Starterpack Decentralised Procedure Public Assessment Report Memantin AbZ 10 mg/20 mg Filmtabletten ; Starterpack Memantin-ratiopharm Starterpackung 5 mg /10 mg /15 mg /20 mg Filmtabletten ;10 mg/20 mg Filmtabletten

More information

Medicinal Products for Human Use HOMEOPATHIC MEDCINAL PRODUCT FOR HUMAN USE. December 2005

Medicinal Products for Human Use HOMEOPATHIC MEDCINAL PRODUCT FOR HUMAN USE. December 2005 EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Brussels, F2/BL D(2005) NOTICE TO APPLICANTS Medicinal Products for Human Use VOLUME 2B Presentation and content

More information

Key findings of the 2016 EMN Focused Study on Family Reunification of Third-Country Nationals in the EU plus Norway

Key findings of the 2016 EMN Focused Study on Family Reunification of Third-Country Nationals in the EU plus Norway Key findings of the 2016 EMN Focused Study on Family Reunification of Third-Country Nationals in the EU plus Norway Nataliya Nikolova EMN Service Provider (ICF) icfi.com Presentation overview Objectives

More information

Report from the CMD(h) meeting held on 17 th, 18 th and 19 th September 2007

Report from the CMD(h) meeting held on 17 th, 18 th and 19 th September 2007 Report from the CMD(h) meeting held on 17 th, 18 th and 19 th September 2007 CMD(h)/EMEA Sub-Group on Paediatric Regulation The CMD(h) and the EMEA have agreed on a procedural guidance to facilitate the

More information

Decentralised Procedure. Public Assessment Report

Decentralised Procedure. Public Assessment Report Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Clozapin Regiomedica 50 mg/ml Suspension zum Einnehmen Clozamedica 50 mg/ml Suspension zum Einnehmen

More information

Decentralised Procedure. Public Assessment Report

Decentralised Procedure. Public Assessment Report Decentralised Procedure Public Assessment Report Venlafaxin ratiopharm Venlafaxin AbZ-Pharma Venlafaxin CT-Arzneimittel prolonged-release capsule hard venlafaxine hydrochloride DE/H/3393-3395/01-03/DC

More information

LIMITE EN COUNCIL OF THE EUROPEAN UNION. Brussels, 7 July /11 LIMITE ENFOPOL 228 DAPIX 81

LIMITE EN COUNCIL OF THE EUROPEAN UNION. Brussels, 7 July /11 LIMITE ENFOPOL 228 DAPIX 81 COUNCIL OF THE EUROPEAN UNION Brussels, 7 July 2011 12390/11 LIMITE ENFOPOL 228 DAPIX 81 NOTE From: Presidency To: Law Enforcement Working Party No. prev. doc.: CM 1508/11 Subject: Results of the questionnaire

More information

Decentralised Procedure. Public Assessment Report. Allopurinol tablets 100 mg Allopurinol tablets 300 mg Allopurinol DE/H/ / /DC

Decentralised Procedure. Public Assessment Report. Allopurinol tablets 100 mg Allopurinol tablets 300 mg Allopurinol DE/H/ / /DC Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Allopurinol tablets 100 mg Allopurinol tablets 300 mg Allopurinol DE/H/1354-1356/001-002/DC Applicant:

More information

Industry and globalisation of herbal medicines

Industry and globalisation of herbal medicines TradReg 2017 Bonn 14 September 2017 Industry and globalisation of herbal medicines Dr Hubertus Cranz Director General Association of the European Self-Medication Industry (AESGP) 7 Avenue de Tervuren,

More information

ATMPs & EU GMP Update. Bryan J Wright July 2017

ATMPs & EU GMP Update. Bryan J Wright July 2017 ATMPs & EU GMP Update Bryan J Wright July 2017 Slide 1 PharmOut 2017 Outline ATMPs What they are? Why are we looking at this subject? The Licensing position of ATMPs and use of PRIME ATMPs and GMP Inspections

More information

Decentralised Procedure. Public Assessment Report. Zolmitriptan Renantos 2.5 mg Orodispersible film 5 mg Orodispersible film DE/H/2295/ /DC

Decentralised Procedure. Public Assessment Report. Zolmitriptan Renantos 2.5 mg Orodispersible film 5 mg Orodispersible film DE/H/2295/ /DC Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Zolmitriptan Renantos 2.5 mg Orodispersible film 5 mg Orodispersible film DE/H/2295/001-002/DC Applicant:

More information

Singapore s Progress on GLP and MAD

Singapore s Progress on GLP and MAD 2010/SOM1/CD/WKSP/025 Agenda Item: Afternoon Session I Singapore s Progress on GLP and MAD Submitted by: Singapore Case Study Workshop on the Chemicals Sector - From Principles to Practice Hiroshima, Japan

More information

Patient reporting update

Patient reporting update Patient reporting update François Houÿez Director of Treatment Information & Access, EURORDIS 8 th Pharmacovigilance stakeholders forum EMA, 15/06/2014 15/09/2014 eurordis.org 1 Spontaneous reporting in

More information

EUROPEAN COMMISSION DIRECTORATE GENERAL FOR HEALTH AND FOOD SAFETY

EUROPEAN COMMISSION DIRECTORATE GENERAL FOR HEALTH AND FOOD SAFETY Ref. Ares(2016)5909621-13/10/2016 EUROPEAN COMMISSION DIRECTORATE GENERAL FOR HEALTH AND FOOD SAFETY Directorate B - Health systems, medical products and innovation B4 Medical products: quality, safety

More information

The Committee for Medicinal Products for Human Use

The Committee for Medicinal Products for Human Use www.eurordis.org The Committee for Medicinal Products for Human Use Patrick Salmon IMB Barcelona, 20 June, 2013 2 EURORDIS SUMMER SCHOOL 2013 CHMP CHMP... What is it? 3 EURORDIS SUMMER SCHOOL 2013 CHMP

More information

Decentralised Procedure. Public Assessment Report. Lorazepam-neuraxpharm 1/ 2,5 mg Schmelztabletten. Lorazepam DE/H/4558/ /DC

Decentralised Procedure. Public Assessment Report. Lorazepam-neuraxpharm 1/ 2,5 mg Schmelztabletten. Lorazepam DE/H/4558/ /DC Decentralised Procedure Public Assessment Report Lorazepam-neuraxpharm 1/ 2,5 mg Schmelztabletten Lorazepam DE/H/4558/001-002/DC Applicant: neuraxpharm Arzneimittel GmbH, Germany Reference Member State

More information

Public Assessment Report Scientific discussion. Ibuprofen 400 mg/100 ml solution for infusion & Ibuprofen 600 mg/100 ml solution for infusion

Public Assessment Report Scientific discussion. Ibuprofen 400 mg/100 ml solution for infusion & Ibuprofen 600 mg/100 ml solution for infusion Public Assessment Report Scientific discussion Ibuprofen 400 mg/100 ml solution for infusion & Ibuprofen 600 mg/100 ml solution for infusion Ibuprofen arginine ES/H/0390/001/DC ES/H/0392/001/DC Applicant:

More information

PUBLIC ASSESSMENT REPORT. Decentralised Procedure DE/H/2858/001/DC. Calcium 1000 mg / Vitamin D3 880 I.U. chewable tablets

PUBLIC ASSESSMENT REPORT. Decentralised Procedure DE/H/2858/001/DC. Calcium 1000 mg / Vitamin D3 880 I.U. chewable tablets Federal Institute for Drugs and Medical Devices PUBLIC ASSESSMENT REPORT Decentralised Procedure DE/H/2858/001/DC Calcium 1000 mg / Vitamin D3 880 I.U. chewable tablets Calcium carbonate, Cholecalciferol

More information

Import Risk Assessment of Plant Pests The EU Situation

Import Risk Assessment of Plant Pests The EU Situation Import Risk Assessment of Plant Pests The EU Situation Jan Schans, NL Plant Protection Service, Wageningen, NL Chair EFSA Panel on Plant Health AFSSA / EFSA Colloquium, 3 October 2008, Paris 1 Overview

More information

Variations & worksharing An industry perspective

Variations & worksharing An industry perspective Variations & worksharing An industry perspective Rémon van Aubel European Medicines Agency/IFAH-Europe Info Day 7-8 March 2013, London 1 Variations - Regulation Commission Regulation (EU) No 1234/2008

More information

Decentralised Procedure. Public Assessment Report. Buprenorphine SUN 2 mg/ 8 mg Sublingual tablets Buprenorphine hydrochloride DE/H/1577/ /DC

Decentralised Procedure. Public Assessment Report. Buprenorphine SUN 2 mg/ 8 mg Sublingual tablets Buprenorphine hydrochloride DE/H/1577/ /DC Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Buprenorphine SUN 2 mg/ 8 mg Sublingual tablets Buprenorphine hydrochloride DE/H/1577/001-002/DC Applicant:

More information

quality and safety of pharmacy preparations in Europe

quality and safety of pharmacy preparations in Europe quality and safety of pharmacy preparations in Europe Henk Scheepers, Pharm D, Senior-Inspector Public Health Supervisory Service Health Care Inspectorate The Netherlands 1 Nothing to disclose 2 1 quality

More information

The European Medicines Agency (EMA)

The European Medicines Agency (EMA) The European Medicines Agency (EMA) Nathalie Bere Patient Relations Public Engagement Department EMA Training Day 29 November, 2016 An agency of the European Union What is the European Medicines Agency

More information

The Committee for Medicinal Products for Human Use

The Committee for Medicinal Products for Human Use www.eurordis.org The Committee for Medicinal Products for Human Use Patrick Salmon HPRA Barcelona, 4th June, 2015 2 CHMP 3 CHMP Move 4 The New CHMP 5 Where it all happens! 6 CHMP... What is it? CHMP What

More information

AESGP views. Johannes Koch, Head of European Policy and International Affairs German Medicines Manufacturers' Association BAH. Who is AESGP?

AESGP views. Johannes Koch, Head of European Policy and International Affairs German Medicines Manufacturers' Association BAH. Who is AESGP? The international Generic Drug Regulators Programme (IGDRP): an initiative to further strengthen collaboration, promote regulatory convergence and improve worksharing at a worldwide level EDQM premises

More information

Update on the revision of the new package leaflet (PL) template. An agency of the European Union

Update on the revision of the new package leaflet (PL) template. An agency of the European Union Update on the revision of the new package leaflet (PL) template An agency of the European Union Contents Regulatory background New QRD package leaflet template -Origin - Contents and structure 2 Regulatory

More information

Screening programmes for Hepatitis B/C in Europe

Screening programmes for Hepatitis B/C in Europe Programme STI, HIV/AIDS and viral hepatitis Screening programmes for Hepatitis B/C in Europe Mika Salminen, Ph.D. European Centre for Disease Prevention and Control Why might screening be needed for hepatitis

More information

Agencia Española de Medicamentos y Productos Sanitarios C/Campezo 1, Edificio Madrid España (Reference Member State)

Agencia Española de Medicamentos y Productos Sanitarios C/Campezo 1, Edificio Madrid España (Reference Member State) DEPARTAMENTO DE MEDICAMENTOS VETERINARIOS Medicamentos y Productos C/Campezo 1, Edificio 8 28022 Madrid España (Reference Member State) DECENTRALISED PROCEDURE FINAL PUBLICLY AVAILABLE ASSESSMENT REPORT

More information

Decentralised Procedure. Public Assessment Report. Nurofen Immedia 200mg Weichkapseln Ibuprofen DE/H/1482/001/DC

Decentralised Procedure. Public Assessment Report. Nurofen Immedia 200mg Weichkapseln Ibuprofen DE/H/1482/001/DC Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Nurofen Immedia 200mg Weichkapseln Ibuprofen DE/H/1482/001/DC Applicant: Reckitt Benckiser Reference

More information

Herbal summaries for the public

Herbal summaries for the public Herbal summaries for the public Involvement of PCOs in preparation of herbal summaries Federica Castellani Medical Information Sector, European Medicines Agency An agency of the European Union Overview

More information

Decentralised Procedure. Public Assessment Report

Decentralised Procedure. Public Assessment Report Decentralised Procedure Public Assessment Report Oxycodon-HCl Sandoz 5/10/20 mg Retardtabletten Kancodal HEXAL 5/10/20 Retardtabletten Oxycodonhydrochlorid- 1 A Pharma 5/10/20 mg Retardtabletten Oxycodone

More information

MRP and DCP new applications in 2007

MRP and DCP new applications in 2007 New Active Substance procedures finalised in 7 8 6 6 MRP DCP Repeat Use Initial Application New Active Substance Mutual Recognition Procedures finalised in 7 by RMS (Total 6) 8 7 6 Repeat Use Initial Application

More information

Regulation of Herbal and Traditional Medicines in Germany BfArM in Dialogue - TradReg 2017

Regulation of Herbal and Traditional Medicines in Germany BfArM in Dialogue - TradReg 2017 Regulation of Herbal and Traditional Medicines in Germany BfArM in Dialogue - TradReg 2017 Prof. Dr. Werner Knöss, Dr. Jacqueline Wiesner TradReg2017 Germany September 2017 Page 1 Federal Institute for

More information

Cooperation between HALMED and GMP Inspectorate in supervision of manufacturers: Croatia s experience so far

Cooperation between HALMED and GMP Inspectorate in supervision of manufacturers: Croatia s experience so far Cooperation between HALMED and GMP Inspectorate in supervision of manufacturers: Croatia s experience so far Ana Boban, MPharm. Agency for Medicinal Product and Medical Devices of Croatia Dubrovnik, 06.05.2013.

More information

ANSES. Agence Nationale du Médicament Vétérinaire (National Agency for Veterinary Drugs) (Reference Member State) BP FOUGERES CEDEX FRANCE

ANSES. Agence Nationale du Médicament Vétérinaire (National Agency for Veterinary Drugs) (Reference Member State) BP FOUGERES CEDEX FRANCE ANSES Agence Nationale du Médicament Vétérinaire (National Agency for Veterinary Drugs) (Reference Member State) BP 90203 35302 FOUGERES CEDEX FRANCE DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT

More information

Institute for State Control of Veterinary Biologicals and Medicines Ústav pro státní kontrolu veterinárních biopreparátů a léčiv

Institute for State Control of Veterinary Biologicals and Medicines Ústav pro státní kontrolu veterinárních biopreparátů a léčiv Institute for State Control of Veterinary Biologicals and Medicines Ústav pro státní kontrolu veterinárních biopreparátů a léčiv Ústav pro státní kontrolu veterinárních biopreparátů a léčiv Hudcova 56

More information

COMMITTEE OF EXPERTS ON THE CLASSIFICATION OF MEDICINES AS REGARDS THEIR SUPPLY (CD-P-PH/PHO) PROGRAMME RESULTS

COMMITTEE OF EXPERTS ON THE CLASSIFICATION OF MEDICINES AS REGARDS THEIR SUPPLY (CD-P-PH/PHO) PROGRAMME RESULTS COMMITTEE OF EXPERTS ON THE CLASSIFICATION OF MEDICINES AS REGARDS THEIR SUPPLY (CD-P-PH/PHO) PROGRAMME RESULTS 2016-2017 Introduction This summary provides an overview of the activities carried out by

More information

Spreading Excellence and Widening Participation

Spreading Excellence and Widening Participation Spreading Excellence and Widening Participation Dr G Ambroziewicz Ankara, 27/02/2017 Research and Background Disparities in research and innovation performance: barrier to competitiveness, growth and jobs

More information

Decentralised Procedure. Public Assessment Report. Budesonid Sandoz 32 / 64 Mikrogramm/Sprühstoß Nasenspray, Suspension.

Decentralised Procedure. Public Assessment Report. Budesonid Sandoz 32 / 64 Mikrogramm/Sprühstoß Nasenspray, Suspension. Decentralised Procedure Public Assessment Report Budesonid Sandoz 32 / 64 Mikrogramm/Sprühstoß Nasenspray, Suspension Budesonide DE/H/0933/001-002/DC Applicant: Sandoz Pharmaceuticals GmbH Reference Member

More information

Decentralised Procedure. Public Assessment Report. Methylphenidate hydrochloride DE/H/2222/ /DC DE/H/2223/ /DC

Decentralised Procedure. Public Assessment Report. Methylphenidate hydrochloride DE/H/2222/ /DC DE/H/2223/ /DC Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Medikinet 5, 10, 20 mg Medikinet retard 5, 10, 20, 30, 40 mg Methylphenidate hydrochloride DE/H/2222/001-003/DC

More information

Annual Report BASG - Federal Office for Safety in Health Care

Annual Report BASG - Federal Office for Safety in Health Care E 2015 Annual Report 2015 BASG - Federal Office for Safety in Health Care 1 Imprint BASG - Federal Office for Safety in Health Care 2015 Traisengasse 5 A-1200 Vienna Tel.: +43 (0)50 555-36111 E-Mail: basg_anfragen@ages.at

More information

Finnish international trade 2017 Figures and diagrams. Finnish Customs Statistics

Finnish international trade 2017 Figures and diagrams. Finnish Customs Statistics Finnish international trade 217 Figures and diagrams Finnish Customs Statistics IMPORTS, EXPORTS AND TRADE BALANCE 199-217 Billion e 7 6 5 4 3 2 1-1 9 91 92 93 94 95 96 97 98 99 1 2 3 4 5 6 7 8 9 1 11

More information

Finnish international trade 2017 Figures and diagrams. Finnish Customs Statistics

Finnish international trade 2017 Figures and diagrams. Finnish Customs Statistics Finnish international trade 217 Figures and diagrams Finnish Customs Statistics IMPORTS, EXPORTS AND TRADE BALANCE 199-217 Billion e 7 6 5 4 3 2 1-1 9 91 92 93 94 95 96 97 98 99 1 2 3 4 5 6 7 8 9 1 11

More information

Internationalisation of green SMEs

Internationalisation of green SMEs Eva Revilla Internationalisation of green SMEs DG Internal Market, Industry, Entrepreneurship and SMEs European Commission 27/05/2015 Internationalisation of green SMEs Where are we? 91% of SMEs sell their

More information

EUROPEAN MEDICINES AGENCY DECISION. of 20 July 2008

EUROPEAN MEDICINES AGENCY DECISION. of 20 July 2008 European Medicines Agency Doc. Ref. EMEA/357907/2008 P/53/2008 EUROPEAN MEDICINES AGENCY DECISION of 20 July 2008 on the application for agreement of a Paediatric Investigation Plan for Atorvastatin calcium

More information

Report from the CMD(h) meeting held from 20 th to 22 nd March 2006

Report from the CMD(h) meeting held from 20 th to 22 nd March 2006 Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human General Issues Report from the CMD(h) meeting held from 20 th to 22 nd March 2006 Meeting on Harmonisation of SPCs with Interested

More information

COOPERATION FOR INCREASED SCIENTIFIC CAPACITY

COOPERATION FOR INCREASED SCIENTIFIC CAPACITY COOPERATION FOR INCREASED SCIENTIFIC CAPACITY Guilhem de Seze Head of Scientific Evaluation of Regulated Products Department, European Food Safety Authority (EFSA) Japan International Conference, 25-26

More information

Public Assessment Report. Scientific discussion. Tadalafil 1A Pharma 2.5 mg, 5 mg, 10 mg and 20 mg, film-coated tablets.

Public Assessment Report. Scientific discussion. Tadalafil 1A Pharma 2.5 mg, 5 mg, 10 mg and 20 mg, film-coated tablets. Public Assessment Report Scientific discussion Tadalafil 1A Pharma 2.5 mg, 5 mg, 10 mg and 20 mg, film-coated tablets (tadalafil) NL/H/3634/001-004/DC Date: 24 May 2017 This module reflects the scientific

More information

List of nationally authorised medicinal products

List of nationally authorised medicinal products 10 September 2015 EMA/622830/2015 Procedure Management and Committees Support Active substance: azelastine Procedure no.: PSUSA/00000277/201412 30 Churchill Place Canary Wharf London E14 5EU United Kingdom

More information

New trends in harm reduction in Europe: progress made challenges ahead

New trends in harm reduction in Europe: progress made challenges ahead New trends in harm reduction in Europe: progress made challenges ahead Dagmar Hedrich, Alessandro Pirona, EMCDDA 2 nd European Harm Reduction Conference, 7-9 May 2014, Basel Session 4: Changes in harm

More information

MiFID Suitability Requirements Peer Review Report - Annex

MiFID Suitability Requirements Peer Review Report - Annex MiFID Suitability Requirements Peer Review Report - Annex 7 April 2016 ESMA/2016/585 Section 1: Questionnaire findings 1. Background information 1. This section contains information on the number of investment

More information

Extrapolation and potential impact of IPHS deployment in Europe

Extrapolation and potential impact of IPHS deployment in Europe SIMPHS2 Validation Workshop Brussels, 31 Jan 2012 1 SIMPHS2 Validation Workshop Extrapolation and potential impact of IPHS deployment in Europe JRC IPTS IS Unit Ioannis Maghiros, Fabienne Abadie, Maria

More information

Public Assessment Report Scientific discussion

Public Assessment Report Scientific discussion Public Assessment Report Scientific discussion Symbicort Turbuhaler, 160 micrograms/4.5 micrograms/inhalation, Symbicort mite Turbuhaler, 80 micrograms/4.5 micrograms/inhalation, Symbicort forte Turbuhaler,

More information

Palliative nursing care of children and young people across Europe

Palliative nursing care of children and young people across Europe Palliative nursing care of children and young people across Europe Results of a postal survey in August 2016 Updated in April 2017 (presented at the 29th PNAE-meeting in Naples/Italy on 28th April 2017)

More information

Schedule 1. New marketing authorisation and renewal of marketing authorisation

Schedule 1. New marketing authorisation and renewal of marketing authorisation and renewal of marketing Schedule 1 The Delimitation column refers to the relevant articles of Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 on the Community code relating

More information

Report from the CMD(h) meeting held on 19 th, 20 th and 21 st March 2007

Report from the CMD(h) meeting held on 19 th, 20 th and 21 st March 2007 Report from the CMD(h) meeting held on 19 th, 20 th and 21 st March 2007 Best Practice Guide EU Work Sharing Procedure in the Assessment of Paediatric Data The CMD(h) has updated the Best Practice Guide

More information

Item 2.2 Household definition

Item 2.2 Household definition EUROPEAN COMMISSION EUROSTAT Directorate F: Social statistics Doc. DSSB/2016/Jun/2.2 Item 2.2 Household definition MEETING OF THE BOARD OF THE EUROPEAN DIRECTORS OF SOCIAL STATISTICS LUXEMBOURG, 28 AND

More information

Trends in injecting drug use in Europe

Trends in injecting drug use in Europe Trends in injecting drug use in Europe Linda Montanari, Bruno Guarita and Danica Thanki Annual Expert Meeting on Drug-Related Infectious Diseases Lisbon, 15-17 October Overview of the presentation 1) Information

More information

United Kingdom Veterinary Medicines Directorate Woodham Lane New Haw Addlestone Surrey KT15 3LS DECENTRALISED PROCEDURE

United Kingdom Veterinary Medicines Directorate Woodham Lane New Haw Addlestone Surrey KT15 3LS DECENTRALISED PROCEDURE United Kingdom Veterinary Medicines Directorate Woodham Lane New Haw Addlestone Surrey KT15 3LS DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT Thyforon

More information

Feedback from the Member States questionnaire

Feedback from the Member States questionnaire Annex 6 Feedback from the Member States questionnaire Reinhilde A.R. Schoonjans Special meeting of the EFSA Advisory Forum on GMO risk assessment in Europe 13 November 2007, Brussels Topics 1. Highlights

More information

2008 Public Status Report on the Implementation of the European Risk Management Strategy. Executive Summary

2008 Public Status Report on the Implementation of the European Risk Management Strategy. Executive Summary European Medicines Agency London, 17 March 2009 Doc. Ref. EMEA/43556/2009 2008 Status Report on the Implementation of the European Risk Management Strategy Executive Summary The European Risk Management

More information

Decentralised Procedure. Public Assessment Report. ALGOTRA 37.5 mg/325 mg überzogene Tabletten Tramadol/Paracetamol DE/H/3688/001/DC

Decentralised Procedure. Public Assessment Report. ALGOTRA 37.5 mg/325 mg überzogene Tabletten Tramadol/Paracetamol DE/H/3688/001/DC Decentralised Procedure Public Assessment Report ALGOTRA 37.5 mg/325 mg überzogene Tabletten Tramadol/Paracetamol DE/H/3688/001/DC Applicant: Laboratoires SMB S.A. Reference Member State DE TABLE OF CONTENTS

More information

DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT DERMIPRED/PREDNISOLONE CEVA 10 MG DATE : JULY 2016

DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT DERMIPRED/PREDNISOLONE CEVA 10 MG DATE : JULY 2016 FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS AGENCE NATIONALE DU MEDICAMENT VETERINAIRE 8 rue Claude Bourgelat Parc d activités de la grande Marche Javené CS 70611 35306 FOUGERES DECENTRALISED PROCEDURE

More information

Standard operating procedure

Standard operating procedure Standard operating procedure Title: Article 29(4) referral procedures (MRP/DCP referrals) Status: PUBLIC Document no.: SOP/H/3177 Lead author Approver Effective date: 04-SEP-12 Name: Thomas Larsson Name:

More information

List of nationally authorised medicinal products

List of nationally authorised medicinal products 26 October 2017 EMA/690754/2017 Human Medicines Evaluation Division Active substance: fish oil / olive oil / soybean oil / triglycerides mediumchain Procedure no.: PSUSA/00010223/201702 30 Churchill Place

More information

EU School Fruit, Vegetables & Milk Scheme 2017/2023

EU School Fruit, Vegetables & Milk Scheme 2017/2023 EU School Fruit, Vegetables & Milk Scheme 2017/2023 What's new High Level Group on Nutrition and Physical Activities Brussels, 29/11/2017 AGRI.G.3 What's new since last High Level Group meeting By 31/7/2017

More information

EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL

EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL Ref. Ares(2015)2319265-03/06/2015 EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL Directorate D - Health systems and products D4 Substances of Human Origin and Tobacco Control Brussels,

More information

Review of Member State approaches to the Macrophyte and Phytobenthos Biological Quality Element in lakes

Review of Member State approaches to the Macrophyte and Phytobenthos Biological Quality Element in lakes Review of Member State approaches to the Macrophyte and Phytobenthos Biological Quality Element in lakes Report to ECOSTAT Martyn Kelly (Bowburn Consultancy, UK) Sebastian Birk (University of Duisburg-Essen,

More information

PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT

PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT PAUL-EHRLICH-INSTITUT Bundesamt für Sera und Impfstoffe Federal Agency for Sera and Vaccines Paul-Ehrlich-Strasse 51-59 63225 Langen Germany MUTUAL RECOGNITION PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT

More information

The European Medicines Agency (EMA)

The European Medicines Agency (EMA) The European Medicines Agency (EMA) Nathalie Bere and Maria Mavris Public Engagement Department EMA Training Day 21 November, 2017 An agency of the European Union What is the European Medicines Agency

More information

Decentralised Procedure. Public Assessment Report. Oxycodon-ratiopharm 20, 40, 80 mg Retardtablette. Oxycodone hydrochloride DE/H/0790/01-03/DC

Decentralised Procedure. Public Assessment Report. Oxycodon-ratiopharm 20, 40, 80 mg Retardtablette. Oxycodone hydrochloride DE/H/0790/01-03/DC Decentralised Procedure Public Assessment Report Oxycodon-ratiopharm 20, 40, 80 mg Retardtablette Oxycodone hydrochloride DE/H/0790/01-03/DC Applicant: ratiopharm GmbH Reference Member State Germany The

More information

PIC/S GUIDANCE ON CLASSIFICATION OF GMP DEFICIENCIES

PIC/S GUIDANCE ON CLASSIFICATION OF GMP DEFICIENCIES PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 040-1 3 Appendices 1 January 2019 PIC/S GUIDANCE ON CLASSIFICATION OF GMP DEFICIENCIES PIC/S January 2019 Reproduction

More information

Work plan for the joint CHMP/ CVMP Quality Working Party (QWP) for 2018

Work plan for the joint CHMP/ CVMP Quality Working Party (QWP) for 2018 4 December 2017 EMA/CHMP/CVMP/QWP/504882/2017 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) Work plan for the joint CHMP/ CVMP Quality

More information

Herbal medicinal products an area of patient involvement? Steffen Bager, HMPC member

Herbal medicinal products an area of patient involvement? Steffen Bager, HMPC member Herbal medicinal products an area of patient involvement? Steffen Bager, HMPC member Herbal medicinal products in Europe Legislation: Procedures to market access: Classification: Borderline issues: Product

More information

Niels Gronau. Senior Manager - Deloitte s Sports Business Group

Niels Gronau. Senior Manager - Deloitte s Sports Business Group Niels Gronau Senior Manager - Deloitte s Sports Business Group EHFA/Deloitte The European Health & Fitness Market Report as of 31.12.2013 Niels Gronau Detailed research led to a comprehensive picture of

More information

EMEA PANDEMIC INFLUENZA CRISIS MANAGEMENT PLAN FOR THE EVALUATION AND MAINTENANCE OF PANDEMIC INFLUENZA VACCINES AND ANTIVIRALS

EMEA PANDEMIC INFLUENZA CRISIS MANAGEMENT PLAN FOR THE EVALUATION AND MAINTENANCE OF PANDEMIC INFLUENZA VACCINES AND ANTIVIRALS European Medicines Agency London, 21 August 2006 Doc. Ref. EMEA/214301/2006 EMEA PANDEMIC INFLUENZA CRISIS MANAGEMENT PLAN FOR THE EVALUATION AND MAINTENANCE OF PANDEMIC INFLUENZA VACCINES AND ANTIVIRALS

More information

Decentralised Procedure. Public Assessment Report

Decentralised Procedure. Public Assessment Report Decentralised Procedure Public Assessment Report Targin 2,5mg/1,25 mg, 15mg/7,5mg, 30mg/15mg Retardtabletten Oxycodone hydrochloride / Naloxone hydrochloride dihydrate DE/H/1612/005-007/DC Applicant: Mundipharma

More information

CHAPTER 3. Union Referral Procedures MAY 2014

CHAPTER 3. Union Referral Procedures MAY 2014 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products Brussels, Revision May 2014 NOTICE TO APPLICANTS VOLUME 2A Procedures for marketing authorisation

More information

EU Market Situation for Poultry. Committee for the Common Organisation of the Agricultural Markets 20 April 2017

EU Market Situation for Poultry. Committee for the Common Organisation of the Agricultural Markets 20 April 2017 EU Market Situation for Poultry Committee for the Common Organisation of the Agricultural Markets 2 April 217 -9.% -11.% -5.% -.1% -.7% -2.2% 3.% 1.7% 1.2%.8%.6%.%.%.% 7.9% 7.% 6.4% 6.2% 6.% 5.5% 5.3%

More information

Dr. Christian Zeine LGC Standards GmbH. Webinar Series 2013 July 2013

Dr. Christian Zeine LGC Standards GmbH. Webinar Series 2013 July 2013 The 7 truths of impurities and their reference standards FDA's and other regulators' viewpoints and further stories (Part 1) Dr. Christian Zeine LGC Standards GmbH Webinar Series 2013 July 2013 Quick guide

More information

State of play of Leader/CLLD preliminary analysis

State of play of Leader/CLLD preliminary analysis State of play of Leader/CLLD preliminary analysis #LeaderCLLD Urszula Budzich-Tabor, ENRD CP Brussels, 23 June 2015 DG AGRI analysis of draft RDPs Indicative allocation of budget for LEADER (total public):

More information

ANNEX GUIDANCE TO MEMBER STATES: SUGGESTED ACTIONS ON BETTER ENVIRONMENTAL IMPLEMENTATION. to the

ANNEX GUIDANCE TO MEMBER STATES: SUGGESTED ACTIONS ON BETTER ENVIRONMENTAL IMPLEMENTATION. to the EUROPEAN COMMISSION Brussels, 3.2.2017 COM(2017) 63 final ANNEX 1 ANNEX GUIDANCE TO MEMBER STATES: SUGGESTED ACTIONS ON BETTER ENVIRONMENTAL IMPLEMENTATION to the THE COMMUNICATION FROM THE COMMISSION

More information