Variations & worksharing An industry perspective
|
|
|
- Suzanna Watkins
- 6 years ago
- Views:
Transcription
1 Variations & worksharing An industry perspective Rémon van Aubel European Medicines Agency/IFAH-Europe Info Day 7-8 March 2013, London 1
2 Variations - Regulation Commission Regulation (EU) No 1234/2008 Since 1 January 2010 Applicable to CAPs and MRP/DCP products Amendment 712/2012 Since 2 November 2012 Extended to NAT products (with transition period) Changes to implementation & amendment MA 2
3 Variations Commission Guidelines Commission guidelines 2010: Procedures & categories 2013: Combined/updated guideline Public consultation Article 4: The commission shall, after consulting the Member States, the Agency and interested parties, draw up guidelines. Short time line (1 month) Industry comments/suggestions reviewed by EC 3
4 Variations Commission Guidelines Increased complexity Categories: high level, 107 (+10); total, 313 (+43) More stringent conditions to allow for type IA Introduction certain terms/expressions Possible consequences Increased administrative burden Discussions between applicants and regulators Re-classifications and delayed procedures Delay improved/upgraded products to the EU market 4
5 Variations Commission Guidelines Areas requested for change by industry Administrative changes Pharmacovigilance Change to 1 national MAH not applicable to other member states in DCP/MRP Type II umbrella concept (slight modifications to the manufacturing process/testing without significant impact on quality/safety/efficacy) Single notification for change covering all MAs per CA (notification removal TABST) Example of an administrative change 5
6 Variations - Example Central AT BE BG CY CZ DK EE FI FR DE GR HU IE IS IT LV LT LU MT NL NO PL PT RO SK SI ES SE UK A.4 A.5.b CAPs 1 Bovilis BTV Equilis Prequenza Equilis Prequenza-Te Nobilis IB Nobilis Influenza H5N Nobilis OR inac Porcilis AR-T DF Porcilis PCV Total DCP/MRP AT BE BG CY CZ DK EE FI FR DE GR HU IE IS IT LV LT LU MT NL NO PL PT RO SK SI ES SE UK A.4 A.5.b 1 Bovilis Bovipast RSP Nobilis Salenvac Nobilis Salenvac T Bovivac S Ovipast Plus Porcilis PRRS Heptavac P plus Nobilis CAV P Nobilis ND C Nobilis E. coli inac MRP/DCP 3 Bovilis IBR Marker Live Nobilis IB Multi+ND+EDS Nobilis Marexine CA Nobilis ND Lasota Nobilis Paramyxo P Nobilis Reo ERS Nobilis RT inac Nobilis RT+IB Multi+G+ND Nobilis RT+IB Multi+ND+EDS Nobilis TRT live Ovilis Enzovax Bovilis BVD Equilis Resequin ** Porcilis Begonia Diluvac Forte Porcilis Begonia IDAL Porcilis Begonia Unisolve Porcilis Ery Porcilis Ery+Parvo Nobilis Rhino CV Porcilis M Hyo Porcilis Parvo Nobilis MG 6/ Norvax Compact PD Nobilis Coryza Total National AT BE BG CY CZ DK EE FI FR DE GR HU IE IS IT LV LT LU MT NL NO PL PT RO SK SI ES SE UK A.4 A.5.b 1 Bovilis Blackleg Bovilis Bovipast RSP Bovilis BVD Equilis Resequin ** Heptavac P plus Lambivac Nobilis AE + Pox Nobilis AE 1143 ** Nobilis CAV P Nobilis Coryza 1 11 Nobilis Coryza Inac Nobilis E. coli inac Nobilis EDS inac Nobilis Erysipelas Nobilis FC Duck inac Nobilis G+ND Nobilis Gumboro 228E Nobilis Gumboro D Nobilis Gumboro inac Nobilis IB H Nobilis IB Ma Nobilis IB Ma5+ND Cl Nobilis IB Multi inac Nobilis IB Multi+G+ND Nobilis IB Multi+ND Nobilis IB Multi+ND+EDS Nobilis IB+G+ND Nobilis IB+ND National Nobilis IB+ND+EDS Nobilis ILT Nobilis Marexine CA Nobilis MG 6/ Nobilis ND Broiler Nobilis ND C Nobilis ND Clone Nobilis ND Lasota Nobilis ND+EDS Nobilis Newcavac Nobilis Paramyxo P Nobilis Reo Nobilis Reo Nobilis Reo ERS inac Nobilis Reo inac Nobilis Reo+IB+G+ND Nobilis Rhino CV Nobilis Rismavac Nobilis Rismavac + CA Nobilis RT inac Nobilis RT+IB Multi+G+ND Nobilis RT+IB Multi+ND+EDS Nobilis RTV Nobilis Salenvac Nobilis Salenvac T Nobilis SG 9R Nobilis TRT live Norvax Minova 4WD Norvax Minova Ovilis Enzovax Ovipast Plus Ovivac P plus Porcilis AR-T (WO) Porcilis Begonia Diluvac Forte Porcilis Begonia IDAL Porcilis Begonia Unisolve Porcilis Ery Porcilis Ery+Parvo Porcilis M Hyo Porcilis Parvo Porcilis PRRS Total Name change of a manufacturing site Two classifications: Active substance (A.4), type IA Finished product (A.5), Type IA 78 products (A.4., A.5, A.4+A.5) Three different types of registration 6
7 Variations Commission Guidelines Immunologicals Changes with no impact on quality, safety or efficacy remain classified as type II New/upgraded categories on TSE certificates, which may lead to confusion and discussion Examples 7
8 Variations Updated guideline on categories TSE certificates B.III.1.b 2. New certificate for a starting material, reagent, intermediate or excipient from a new or an already approved manufacturer 4. New/updated certificate from an already approved/new manufacturer using materials of human or animal origin for which an assessment of the risk with respect to potential contamination with adventitious agents is required Conditions Condition Type 3, 6, 9 IA 3. The manufacturing process does not include the use of materials of human or animal origin for which an assessment of viral safety data is required. x x II IB 8
9 Variations Updated guideline on categories TSE certificates B.III.1.b 3. Updated certificate from an already approved manufacturer 4. New/updated certificate from an already approved/new manufacturer using materials of human or animal origin for which an assessment of the risk with respect to potential contamination with adventitious agents is required Conditions 7. There has been no change in the source of material Condition Type x x 7, 9 IA II IB Can lead to request for risk assessment (?) 9
10 Worksharing One variation or same group of variations of type II or IB for more than one MA (line extension excluded) Apply 3 months in advance at EMA or CMDv All changes must be the same By default: 60 days procedure NAT products: Until August 2013: excluded o CMDv proactive on informal WS o NAT member states can step out ( and they did?) After August 2013: included, all member states shall approve the change(s) 10
11 it may get a bit bumpy. but we ll get there Thank you 11
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
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
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'
Ensuring protection of public health and patients in member states: priorities, constraints, opportunities
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
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
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
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
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,
Commission. Product. Notification 1. Decision. Information issued on. Issued 2 / affected 3 amended on. 12/12/2018 Annex II and PL.
Procedural steps taken and scientific information after the authorisation Application Scope Opinion/ Commission Product Summary number Notification 1 Decision Information issued on Issued 2 / affected
Non-reproductive tissues and cells
Colour key Minimum requirements as set out in Directive 2004/23/EC and its technical Directives (particularly 2006/17/EC) More stringent -legally binding, applies for all donations and all donor profiles
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)
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
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
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
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
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
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
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
Commission. Product. Notification. Decision. Issued 2 / affected 3 amended on
Procedural steps taken and scientific information after the authorisation Application Scope Opinion/ Commission Product Summary number Notification Decision Information 1 issued on Issued 2 / affected
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
'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
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
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
C IED in the EU from a military perspective. UN CCW AP II C IED Experts Meeting 8 & 9 April 2013
C IED in the EU from a military perspective UN CCW AP II C IED Experts Meeting 8 & 9 April 2013 Agenda EEAS & EUMS EDA Background projects European External Action Service Based on a Common Foreign and
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
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
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
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
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
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
Seasonal influenza vaccination Recommendations & Reality
Seasonal influenza vaccination Recommendations & Reality World Vaccine Congress, 16-18 October 2012, Lyon, France Caroline Brown Influenza and other Respiratory Pathogens WHO Regional Office for Europe
Commission. Product. Notification. Decision. Issued 2 / affected 3 amended on 11/01/2019 PL
Procedural steps taken and scientific information after the authorisation Application Scope Opinion/ Commission Product Summary number Notification Decision Information 1 issued on Issued 2 / affected
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
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%
Consequence of the change in the definition of. an agricultural parcel
Ispra, 03-04 April 2008 Kick-off Meeting of the 2008 CwRS Campaign 1 Consequence of the change in the definition of Andrew ROWLANDS MARS-PAC, JRC Ispra an agricultural parcel Ispra, 03-04 April 2008 Kick-off
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,
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
ANNUAL REPORT on surveillance for avian influenza in poultry in the EU in 2009
EUROPEAN COMMISSION ANNUAL REPORT on surveillance for avian influenza in poultry in the EU in 2009 Prepared by the European Union Reference Laboratory for Avian Influenza Neither the European Commission
Annual Report on surveillance. for avian influenza in poultry in Member States of the European Union in Health and Consumers
Annual Report on surveillance for avian influenza in poultry in Member States of the European Union in 2011 Health and Consumers Annual Report on surveillance for avian influenza in poultry in Member
European Commission. Annual Report on surveillance for avian influenza in poultry in Member States of the European Union in 2010
European Commission Annual Report on surveillance for avian influenza in poultry in Member States of the European Union in 2010 Nei t hert heeur opeancommi ssi onnoranyper sonact i ngonbehal foft hecommi
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
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
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
Implementation of Smoke-free laws in the EU: Measures by Member State (Situation as of June 2009)
MS Scope of current regulation Entry into force Further developments 1. Total protection in all enclosed workplaces and public places (smoking banned altogether) IE Ban on smoking in all enclosed workplaces
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
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
Annual Report on surveillance for avian influenza in poultry and in wild birds in Member States of the
Annual Report on surveillance for avian influenza in poultry and in wild birds in Member States of the European Union in 2012 Health and Consumers Annual Report on surveillance for avian influenza in
Rhynchophorus ferrugineus in Europe survey results Nándor Pete
Food and Veterinary Office Rhynchophorus ferrugineus in Europe survey results Nándor Pete Topics General situation in the EU Specific situation of the Member States Interceptions Conclusions R. ferrugineus
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
Commission. Product. Notification. Decision. Issued 2 / affected 3 amended on 18/05/2018 PL. 15/03/2018 n/a
Procedural steps taken and scientific information after the authorisation Application Scope Opinion/ Commission Product Summary number Notification Decision Information 1 issued on Issued 2 / affected
Attention. Therefore, all the data and statements made in this presentation are preliminary and might change in the future.
Attention The aim of the Dose Datamed II workshop in Athens was to present preliminary data, collect feedback from the audience and to work towards final results and conclusions. Therefore, all the data
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:
Matrix-induced Signal Enhancement of Propamocarb in LC-MS/MS
Observations concerning a compound a matrix a method other Matrix-induced Signal Enhancement of Propamocarb in LC-MS/MS Reported by: EURL-SRM Version 1 (last update: 24.10.2012) Brief description of problem/observation/solution:
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
Calypso Application. License for card and portable objects.
Calypso Application License for card and portable objects. I N N O V A T R O N CalypsoLicense page 1 / 6 Innovatron, 27 rue de Bassano, 75008 Paris, France 1. License Policy General Presentation Innovatron
FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT
FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS DECENTRALISED PROCEDURE FOR A VETERINARY MEDICINAL PRODUCT NEOMAY 500 000 IU/g powder for use in drinking water /milk. Date: 28/10/2016 French agency for
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
List of nationally authorised medicinal products
28 September 2017 EMA/658449/2017 Human Medicines Evaluation Division Active substance: olodaterol Procedure no.: PSUSA/00010245/201703 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
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)
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
(43) Publication date: 04 September 2014 ( ) (22) Filing Date: 27 February 2014 ( )
(54) Title (EN): INCOHERENT TYPE-III MATERIALS FOR CHARGE CARRIERS CONTROL DEVICES (54) Title (FR): MATÉRIAUX DE TYPE III INCOHÉRENTS POUR DISPOSITIFS DE RÉGULATION DE PORTEURS DE CHARGES (72) Inventor(s):
Assessment of PM2.5 concentrations
Assessment of PM2.5 concentrations and health impacts at a European level 14 th EIONET workshop on air quality assessment and management Warsaw 5-6 October 29 Frank de Leeuw, Jan Horálek PM2.5 monitoring
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):
List of nationally authorised medicinal products
8 March 2018 EMA/182668/2018 Human Medicines Evaluation Division Active substance(s): triamcinolone (topical and nasal formulations) Procedure No.: PSUSA/00003017/201707 30 Churchill Place Canary Wharf
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
List of nationally authorised medicinal products
10 September 2015 EMA/612853/2015 Procedure Management and Committees Support Active substance: tobramycin (nebuliser solution) Procedure no.: PSUSA/00009316/201412 30 Churchill Place Canary Wharf London
The European Commission s science and knowledge service Smart Baltic
The European Commission s science and knowledge service Joint Research Centre S3P ENERGY WORKSHOP Smart Baltic Smart grid challenges and opportunities in the Baltic region flaviagangale@ec.europa.eu JRC
Transmission, processing and publication of HBS 2015 data
EUROPEAN COMMISSION EUROSTAT Directorate F: Social statistics Unit F-4: Income and living conditions; Quality of life Doc. LC-ILC/194/17/EN estat.f.4 (2017) WORKING GROUP ON INCOME AND LIVING CONDITIONS
COMMISSION STAFF WORKING DOCUMENT
EUROPEAN COMMISSION Brussels, 13.11.2012 SWD(2012) 366 final COMMISSION STAFF WORKING DOCUMENT Detailed analysis of countries' reports on the implementation of the Council Recommendation (2009/C 151/01)
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL ON FOOD INGREDIENTS TREATED WITH IONISING RADIATION FOR THE YEAR 2012
EUROPEAN COMMISSION Brussels, 4.2.2014 COM(2014) 52 final REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL ON FOOD INGREDIENTS TREATED WITH IONISING RADIATION FOR THE YEAR 2012 EN
Commission. Product. Notification. Decision. Issued 2 / affected 3 amended on. 08/03/2018 n/a
Procedural steps taken and scientific information after the authorisation Application Scope Opinion/ Commission Product Summary number Notification Decision Information 1 issued on Issued 2 / affected
Commission. Product. Notification. Decision. Issued 2 / affected 3 amended on 05/03/2018 PL
Procedural steps taken and scientific information after the authorisation Application Scope Opinion/ Commission Product Summary number Notification Decision Information 1 issued on Issued 2 / affected
Commission. Product. Notification. Decision. Issued 2 / affected 3 amended on
Procedural steps taken and scientific information after the authorisation Application Scope Opinion/ Commission Product Summary number Notification Decision Information 1 issued on Issued 2 / affected
European Union herbal monograph on Eschscholzia californica Cham., herba
28 January 2015 EMA/HMPC/680372/2013 Committee on Herbal Medicinal Products (HMPC) European Union herbal monograph on Eschscholzia californica Cham., herba Final Discussion in Working Party on European
Meeting the challenge of EU registration
N 5/212 Meeting the challenge of EU registration S EDITORIAL Dear Reader, The legal requirements for the production of farm animals are constantly growing. New EU regulations and directives are aimed at
COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL COMMUNITY HERBAL MONOGRAPH ON HAMAMELIS VIRGINIANA L., FOLIUM
European Medicines Agency Evaluation of Medicines for Human Use London, 12 November 2009 Doc. Ref.: EMA/HMPC/114586/2008 COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) FINAL COMMUNITY HERBAL MONOGRAPH ON
WO 2012/ A3. 15 November 2012 ( ) P O P C T
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International
Fresh fruit and vegetable production, trade, supply & consumption monitor in the EU-27 (covering ) With the support of:
Fresh fruit and vegetable production, trade, supply & consumption monitor in the EU-27 (covering 2005-2010) With the support of: Freshfel Fruit and Vegetable Production, Trade, Supply & Consumption Monitor
Scientific Opinion on Campylobacter
Scientific Opinion on Campylobacter in broiler meat production: control options and performance objectives and/or targets at different stages of the food chain EFSA-Q-2009-233 FAVV Symposium 25 November
List of nationally authorised medicinal products
06 July 2017 EMA/436040/2017 Human Medicines Evaluation Division Active substance: Procedure no.: PSUSA/00001815/201610 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20
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
Report. Survey conducted by TNS political & social
Food waste and date marking Survey conducted by TNS political & social This document does not represent the point of view of the European Commission. The interpretations and opinions contained in it are
Young people and drugs. Analytical report
Flash Eurobarometer European Commission Young people and drugs among 15-24 year-olds Analytical report Fieldwork: May 2008 Report: May 2008 Flash Eurobarometer 233 The Gallup Organization This survey was
Commission. Product. Notification. Decision. Issued 2 / affected 3 amended on
Procedural steps taken and scientific information after the authorisation Application Scope Opinion/ Commission Product Summary number Notification Decision Information 1 issued on Issued 2 / affected
EURL-SRM - Analytical Observations Report
concerning the following EURL-SRM - Analytical Observations Report o Compound(s): AMTT (metabolite of tritosulfuron) o Commodities: Fruit and vegetables, cereals o Extraction Method(s): o Instrumental
TEPZZ _7584 A_T EP A1 (19) (11) EP A1 (12) EUROPEAN PATENT APPLICATION. (51) Int Cl.: A61K 9/00 ( ) A61K 31/439 (2006.
(19) TEPZZ _784 A_T (11) EP 3 17 842 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: 07.06.17 Bulletin 17/23 (1) Int Cl.: A61K 9/00 (06.01) A61K 31/439 (06.01) (21) Application number: 1197874.9
List of nationally authorised medicinal products
09 June 2017 EMA/36849/2017 Human Medicines Evaluation Division Active substance(s): brimonidine / timolol Procedure No.: PSUSA/00000431/201609 30 Churchill Place Canary Wharf London E14 5EU United Kingdom
RC4-1. User s instructions RC4-1 remote control
RC4-1 User s instructions RC4-1 remote control The remote control and any other parts shown in these user s instructions may not look the same as the one(s) you have. We furthermore reserve the right to
Date: 7 October Dear Mr Hunt, Re: Tobacco Products Directive and snus
To: Rt Hon Jeremy Hunt MP Secretary of State for Health Richmond House London SW1A 2NS mb- sofs@dh.gsi.gov.uk CC: UK Members of the European Parliament From: Specialists in tobacco and public health Date:
31 countries (117 registries, 20 national) Increased coverage in countries with regional registries 50% European population Overall >20 million
31 countries (117 registries, 20 national) Increased coverage in countries with regional registries 50% European population Overall >20 million cancer cases Adult patients (age 15+) 45 major cancer sites
Funded by EAHC (tender EAHC/2012/Health/06 - Lot 2) Cooperation between GfK Belgium (contractor) and RAND Europe (advisor) 1
STATE OF PLAY IN THE USE OF ALCOHOLIC BEVERAGE LABELS TO INFORM CONSUMERS ABOUT HEALTH ASPECTS ACTION TO PREVENT AND REDUCE HARM FROM ALCOHOL Sara Gysen GfK Belgium, Public Services Funded by EAHC (tender
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
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
Brussels, XXX SANCO/10181/2014 [ ](2014) XXX draft
 XXX draft](/thumbs/89/97533642.jpg "Brussels, XXX SANCO/10181/2014 [ ](2014) XXX draft")
Brussels, XXX SANCO/10181/20 [ ](20) XXX draft WORKING DOCUMENT SANCO/10181/20 Rev2 Guidelines for the Union co-funded programmes of eradication, control and surveillance of animal diseases and zoonoses
List of nationally authorised medicinal products
14 April 2016 EMA/284169/2016 Procedure Management and Committees Support Active substance: influenza vaccine (split virion, inactivated) (non centrally products) Procedure no.: PSUSA/00010298/201508 30
TEPZZ 85_Z 4A_T EP A1 (19) (11) EP A1 (12) EUROPEAN PATENT APPLICATION
(19) TEPZZ 8_Z 4A_T (11) EP 2 81 034 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: 2.03.1 Bulletin 1/13 (21) Application number: 1022.2 (1) Int Cl.: A61C /02 (06.01) A61C 19/04 (06.01)
Material deprivation in the EU Revising the current indicators and exploring the deprivation order in EU countries
Material deprivation in the EU Revising the current indicators and exploring the deprivation order in EU countries Anne-Catherine Guio (LISER - CEPS/INSTEAD) Since 2009, EU portfolio of commonly agreed
List of nationally authorised medicinal products
17 May 2018 EMA/303456/2018 Human Medicines Evaluation Division Active substance: bromazepam Procedure no.: PSUSA/00000435/201708 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone
At-A-Glance report 2014
At-A-Glance report 14 Cystic Fibrosis in Europe Facts and Figures 14 The European Cystic Fibrosis Society Patient Registry (ECFSPR) is happy to present this report with key information about how cystic
Community herbal monograph on Orthosiphon stamineus Benth., folium
11 March 2010 EMA/HMPC/281496/2009 Committee on Herbal Medicinal Products (HMPC) Community herbal monograph on Orthosiphon stamineus Benth., folium Final Discussion in Working Party on Community monographs