KEY DIFFERENCES BETWEEN THE NEW MEDICAL DEVICE AND THE OTC REGULATIONS IN EUROPE
|
|
- Mervin Todd
- 5 years ago
- Views:
Transcription
1 RNI Conseil 2017 Tous droits réservés Toute reproduction interdite sans l'autorisation de l'auteur. KEY DIFFERENCES BETWEEN THE NEW MEDICAL DEVICE AND THE OTC REGULATIONS IN EUROPE Anne Laure TARDY, PhD 26 October 2017 Produits de Nutrition & de Santé Stratégie Règlementaire Expertise scientifique, médicale et toxicologique Expertise à l international
2 Table of content Products regulatory frameworks & definition Classification of the products Key actors of the systems Safety/ efficacy requirements & drafting application Marketing procedure and authorization Conclusion
3 PRODUCTS REGULATORY FRAMEWORKS & DEFINITION
4 Regulatory framework of medical devices KEY DATES IN THE APPLICATION OF THE NEW MDR Enter into force : 26 may 2017 Shall apply from 26 May 2020, with the exception of the o Chapter IV on notified body: 26 november 2017 o Chapter VIII on the cooperation with the MS : 26 may 2018 KEY OBJECTIVES OF THE NEW MDR Improve security for patients and users Improve the traceability of MD Strengthen the role of notified bodies Specify the obligations of manufacturers, importers and distributors Strengthen the requirements for clinical evidence
5 Definition of medical device According to the Article 2 of the Regulation (EU) 2017/745: Medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for [ ] specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, [ ], investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, [ ], and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
6 Definition of medical device According to Annex 1 of the Regulation (EU) 2017/745 : GENERAL REQUIREMENTS, devices should Achieve the performance intended by their manufacturer Be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. Be safe and effective and shall not compromise the clinical condition or the safety of patients or of users Constitute acceptable risks when weighed against the benefits to the patient REQUIREMENTS REGARDING DESIGN AND MANUFACTURE REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE
7 Regulatory framework of medicinal products KEY CONTENTS Requirements and procedures for the marketing authorization Rules for the constant supervision of products after their authorization Harmonized provisions in areas such as the manufacturing or advertising SPECIFIC RULES FOR CERTAIN TYPES OF MEDICINAL PRODUCTS Regulation (EC) No 141/2000 : orphan medicinal products Regulation (EC) No 1901/2006: medicinal products for children Regulation (EC) No 1394/2007 : advanced therapy medicinal products Directive 2004/24/EC : on specific provisions applicable to herbal medicinal products
8 Definition of medicinal products According to Article 1(2) of the Directive 2001/83/EC: Medicinal product: (a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings presentation of the medicinal product and to the claims made for it (b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. its function and intended use. According to settled case law of the European Court of Justice (ECJ), 'a product is a medicinal product if it falls within either of those two definitions'.
9 CLASSIFICATION OF THE PRODUCTS
10 Classification rules of medical devices According to Article 51 & Annex VIII of the Regulation (EU) 2017/745: Devices are divided into classes I, IIa, IIb and III, taking into account the intended purpose and their inherent risks. Any concern between the manufacturer and the notified body shall be referred for a decision to the competent authority Important definition: Duration of use Transient : continuous use for less than 60 minutes. Short term : continuous use for between 60 minutes and 30 days. Long term : continuous use for more than 30 days Invasive and active devices
11 Classification rules of medical devices According to the Annex VIII of the Regulation (EU) 2017/745: 22 rules to determine the class of the MD (vs 18 rules in the current regulation) Rules 1 to 4 : Non-invasive Devices (ex: rule 4: non-invasive devices which come into contact with injured skin or mucous membrane) Rules 5 to 8 : Invasive Devices Rules 9 to 13: Active Devices Rules 14 to 22 : Special rules Rule 14 : All devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product are classified as class III Rule 19 : Device containing nanomaterials Rule 21: Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body
12 Classification of medicinal products According to Articles 70 to 75 of the Directive 2001/83/EC: Art 70: CA specify the classification of the medicinal product into: a medicinal product subject to medical prescription, a medicinal product not subject to medical prescription. Art 72: Subject to medical prescription if they: are likely to present a danger even when used correctly, if utilized without medical supervision are frequently used incorrectly and are likely to present a danger to human health contain substances thereof, the activity and/or adverse reactions of which require further investigation are normally prescribed by a doctor to be administered parenterally Art 73: Draw up a list of the medicinal products subject to medical prescription on their territory.
13 Products classification: where is the limit? What are borderline products? An increasing number of products may fall within the scope of two definitions: medicinal products and food products/food supplements, medical devices, biocides or cosmetics Tools to help the stakeholders: Manual of Decision (Manual on borderline and classification in the community regulatory framework for medical devices (Version 1.17 ( )) MEDDEV (Meddev 2.4/1 Rev 9 June Classification of medical devices) Guidelines about «A GUIDELINE ON CHANGING THE CLASSIFICATION FOR THE SUPPLY OF A MEDICINAL PRODUCT FOR HUMAN USE) (EMA, 2006) If uncertainty over the classification, the stricter regime of medicinal products applies: ultimate aim being to protect the user.
14 KEY ACTORS OF THE SYSTEMS
15 Key actors of the medical devices NATIONAL COMPETENT AUTHORITY Responsible for market surveillance and / or vigilance (ex: materiovigilance, product classification, control of advertisement ) MANUFACTURER a natural or legal person who manufactures or fully refurbishes a device, and markets that device under its name or trademark Ensure that product is compliant with requirements of the MDR (article 10) NOTIFIED BODY Conformity assessment body designated in accordance with the MDR Submission of applications: before December 1, 2017 New requirements set out in Appendix VII Inspection (3 experts + Country Competent Authority) for documentation reviews and on-site audit of each candidate Designation : no later than 1 October 2018 (quite late for implementation of the Regulation as of May 2020) IMPORTER AND DISTRIBUTOR
16 Key actors of the medical devices EUDAMED- European database on medical devices (Article 33 of the Regulation (EU) 2017/745): Objectives Transparency and adequate access to information Provide a sound basis for regulatory decision-making Build confidence in the regulatory system Several level of access depending on the user : member states, notified body, manufacturer & public Eudamed shall include the following electronic systems: the electronic system for registration of devices the UDI-database (Unique Device Identifier) the electronic system on registration of economic operators the electronic system on notified bodies and on certificates the electronic system on clinical investigations the electronic system on vigilance and post-market surveillance the electronic system on market surveillance
17 Key actors of the medicinal products European Medicine Agency Draw up scientific opinions for the evaluation of medicines for the EU institutions and the Member States. Seven scientific committees : Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) Committee for Orphan Medicinal Products (COMP) Committee on Herbal Medicinal Products (HMPC) Committee for Advanced Therapies (CAT) Paediatric Committee (PDCO) Pharmacovigilance Risk Assessment Committee (PRAC) National Medicine Agency For national authorization procedure: mutual recognition procedure and decentralized procedure Equivalent missions of EMA but at national level
18 SAFETY/ EFFICACY REQUIREMENTS & DRAFTING APPLICATION
19 Annex II Safety/ efficacy requirements & technical file for medical devices The technical file is mandatory for all the products (Annex II & III) Device description and specification Label / packaging/ notice Design and manufacturing information General safety and performance requirements Benefit-risk analysis and risk management Product verification and validation (clinical, preclinical, additional information required in specific cases Technical documentation on post-market surveillance (Annex III) Standards are not mandatory but they have a particular importance meeting them when they exist makes it easier to meet the corresponding general requirements. Some, known as "harmonized", even presume compliance with these requirements. It is necessary to identify the applicable standards and to motivate their possible non-application
20 Safety/ efficacy requirements & technical file for medical devices Standard for risk management NF EN ISO 14971: 2013 Application of risk management to medical devices Global evaluation to manage all the risk link to the product (at each step of the life of the product): identification, evaluation, control, residual risk assessment Standards for safety evaluation ISO : Biological evaluation of medical devices Standards for performance evaluation NF EN ISO 14155: 2012 on clinical investigation MEDDEV Guidances 271 rev 4 for drafting clinical evaluation report Standards for quality management NF EN ISO 13485: 2016 : on quality management
21 Safety/ efficacy requirements & technical file for medical devices Biological evaluation report ISO : Biological evaluation of medical devices
22 Safety/ efficacy requirements & technical file for medical devices Clinical efficacy & safety: clinical evaluation report KEY CONTENTS Must be draft for all MD class (advise : follow the MEDDEV 271 rev 4) Objective: Compile, evaluate and analyse the clinical data to justify the performance and safety through the entire life of the product Appendix A9 : Example of template Equivalence demonstrated based on MEDDEV guidelines Data in the literature available to answer General requirements (safety, performance, benefit / risk ratio, secondary effects) based on the MEDDEV criteria DRAFT OF CLINICAL EVALUATION REPORT Equivalence not demonstrated Data from the literature are insufficient Clinical investigation is required DRAFT OF CLINICAL EVALUATION REPORT
23 Safety/ efficacy requirements & technical file for medical devices Clinical efficacy & safety: clinical evaluation report Conformity assessment with requirement on: safety acceptable benefit/risk profile performance acceptability of undesirable side-effects Data issued by the manufacturer (pre & post marketing, pre clinical studies.) Data issued from the literature on the MD or on an equivalent MD (must be clear and justified) sample size and power calculation relevance of endpoints inclusion and exclusion criteria methods used for quantifying symptoms and outcomes reporting of serious adverse events Guidance 271 rev 4 du MEDDEV
24 Safety/ efficacy requirements & CTD dossier for medicinal products Common technical document Since July 2003, mandatory format for new drug applications in the EU The dossier is organized into five modules : Module 1 is region specific and modules 2, 3, 4 and 5 are intended to be common for all regions.
25 Safety/ efficacy requirements & CTD dossier for medicinal products Non clinical overview and non clinical summaries
26 Cinical overview and clinical summaries Safety/ efficacy requirements & CTD dossier for medicinal products
27 MARKETING PROCEDURE AND AUTHORIZATION
28 Marketing procedure and authorization for medical devices CE marking of conformity or CE marking Definition = a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in the Regulation For class I medical devices Autocertification by the manufacturer For the other classes Evaluation by the notified bodies Obtention of CE marking gives the autorisation to commercialize in all the EU Member States
29 Marketing procedure and authorization for medicinal products Required before launching a drug on the European market EU authorization are granted by the EC through the centralized procedure following an application to the EMA. National authorizations are granted by the Member States through the national competent authorities Centralized procedure (Regulation (EC) N 726/2004) A single scientific assessment procedure of the highest standard for the medicinal products falling within its scope Mandatory for certain drugs & optional for other Results in a single marketing authorization that is valid in all Member States and offers, among other things, the benefit of direct access to the EU market.
30 Marketing procedure and authorization for medicinal products Decentralized procedure (Directive 2001/83/EC) For products that have never been marketed in a MS The 'reference Member State carries out the initial evaluation and issues a draft assessment report. The other MS in which applications were submitted either agree with the evaluation or ask further questions. Once all issues are resolved and the application is successful, national marketing authorizations will be issued in the reference MS and the other MS concerned Mutual recognition procedure (Directive 2001/83/EC) Applies to medicinal products that have already been authorized in a MS. The MS that issued the original national marketing authorization submits its evaluation to the MS in which the stakeholder wants to market its product These are then asked to mutually recognize the marketing authorization. If the applicant is successful, each MS concerned will issue a national marketing authorization.
31 CONCLUSION: KEY MESSAGES TO BRING HOME
32 Conclusion: key messages to bring home MEDICAL DEVICES MEDICINAL PRODUCTS/ OTC Indication Medical purposes Medical purposes Mode of action «Mechanic» Pharmacological Actors Dossier Marketing autorisation Procedure Manufacturer/ Notified Body/ National competent agency Technical File+ standards & guidances (advised +++) Auto- certification & notified body CE marking -> all MS Manufacturer/ National& European Competent Agency CTD Dossier (mandatory) National& European Competent Agency Centralized -> all MS Decentralized & mutual recognition procedure -> specific MS A lot of other things : quality assessment, post marketing surveillance have to be taken into account
33 Mail:
EU Regulatory Requirements Update, the latest news and developments. Hans-Heiner Junker TÜV SÜD Product Service GmbH October 2013
EU Regulatory Requirements Update, the latest news and developments Hans-Heiner Junker TÜV SÜD Product Service GmbH October 2013 Folie 1 Content Two groups of Notified Bodies Designation process with European
More informationQA Regulatory forum: Classification and Risk assessment according to MDR Date : T h e r e s e. A l b i n s s o m e d q t e c h.
QA Regulatory forum: Classification and Risk assessment according to MDR Date : 05.04.2018 THERESE ALBINSSON T h e r e s e. A l b i n s s o n @ m e d q t e c h. s e MedQtech AB MedQtech AB is a consultant
More informationCOMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
The European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 15 December 2005 EMEA/357981/2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON PROCEDURES
More informationIntroduction. Doc-Biocides-2002/01 Version
Doc-Biocides-2002/01 Version 08.01.2008 Guidance document agreed between the Commission services and the competent authorities of the Member States for the Biocidal Products Directive 98/8/EC and for the
More informationWorkshop 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 informationCOMMISSION OF THE EUROPEAN COMMUNITIES REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT
EN EN EN COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 5.12.2008 COM(2008) 824 final REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT on the use of substances other than vitamins
More informationAGREEMENT ON COMMON PRINCIPLES AND RULES OF CIRCULATION OF MEDICINAL PRODUCTS WITHIN THE EURASIAN ECONOMIC UNION. (Moscow, 23 December 2014)
AGREEMENT ON COMMON PRINCIPLES AND RULES OF CIRCULATION OF MEDICINAL PRODUCTS WITHIN THE EURASIAN ECONOMIC UNION (Moscow, 23 December 2014) Member States of the Eurasian Economic Union, hereinafter referred
More informationOther EU Activities Contributing to Harmonization of Labeling
Other EU Activities Contributing to Harmonization of Labeling Dr Laurent Brassart European Medicines Agency Medical Information Sector DIA Labeling Harmonisation 2011 Workshop October 13-14. 2011 Disclaimer
More informationMedical Devices Act 1
Issuer: Riigikogu Type: act In force from: 01.01.2016 In force until: 31.05.2016 Translation published: 01.02.2016 Medical Devices Act 1 Amended by the following acts Passed 13.10.2004 RT I 2004, 75, 520
More informationMedical Devices. UKRAINE Magisters
Medical Devices UKRAINE Magisters CONTACT INFORMATION Oleg Boichuk, Senior Associate Oleksandr Liulkov, Associate Magisters 38 Volodymyrska St., Kyiv, Ukraine +38044 492 82 82 www.magisters.com 1. Definition
More informationGood Laboratory Practice. EU-Serbia screening meeting Brussels, 19 June 2014
Good Laboratory Practice EU-Serbia screening meeting Brussels, 19 June 2014 Table of contents 1. Background information on the principles of GLP 2. EU legal basis for GLP 3. Role of Member States 4. Role
More informationPaediatric Investigation Plans for treatment of osteoporosis
Paediatric Investigation Plans for treatment of osteoporosis Presentation to EMA expert meeting 2 June 2014 Presented by: Richard Veselý Scientific officer An agency of the European Union The European
More informationThe 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 informationThe 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 informationFrequently asked questions
13 February 2017 EMA/527628/2011 Rev. 1 Directorate This document provides answers to the most frequently asked questions received by the European Medicines Agency (EMA).If the answer to your question
More informationIndustry s Perspective on the Status of Medical Device Regulations. FUNDISA Workshop 09 & 10 Oct Anele Vutha SAMED Regulatory Committee
Industry s Perspective on the Status of Medical Device Regulations FUNDISA Workshop 09 & 10 Oct 2014 Anele Vutha SAMED Regulatory Committee Today s Topics: 1. Medical Device Definition - Differences 2.
More informationSecretary-General of the European Commission, signed by Mr Jordi AYET PUIGARNAU, Director
COUNCIL OF THE EUROPEAN UNION Brussels, 13 February 2014 (OR. en) 6438/14 COVER NOTE From: date of receipt: 3 February 2014 To: No. Cion doc.: PHARM 14 SAN 72 MI 161 COMPET 107 DELACT 29 Secretary-General
More informationCOMPETENT AUTHORITY (UK) MEDICAL DEVICES DIRECTIVES GUIDANCE NOTES FOR MANUFACTURERS OF DENTAL APPLIANCES
COMPETENT AUTHORITY (UK) 10 EC MEDICAL DEVICES DIRECTIVES GUIDANCE NOTES FOR MANUFACTURERS OF DENTAL APPLIANCES (CUSTOM MADE DEVICES) Updated March 2008 CONTENTS PAGE Introduction 3 Definition of dental
More informationThe New Regulations - Special IVD Issues
The New Regulations - Special IVD Issues Dirk Stynen, Ph. D. President - Principal Consultant Qarad Geel, Belgium RMD Brussels October 2018 The IVD Regulation 2017/746 October 29, 2018 www.qarad.com 2
More informationGLP in the European Union Ecolabel detergents, GLP and accreditation
GLP in the European Union Ecolabel detergents, GLP and accreditation Maik Schmahl Brussels, 25/03/2010 Chemicals Unit Outline What is GLP? How has it developed? The role of the Member States, the European
More information11. European Union Regulation of In Vitro Diagnostic Medical Devices
11. European Union Regulation of In Vitro Diagnostic Medical Devices By Grant Castle and Robin Blaney I. Introduction This chapter discusses the European Union (EU) regulation of in vitro diagnostic (IVD)
More informationCOMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
European Medicines Agency London, 26 July 2006 Doc. Ref. EMEA/186279/2006 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON LEGAL STATUS FOR THE SUPPLY TO THE PATIENT OF CENTRALLY AUTHORISED
More informationGuidelines to Commission Regulation (EU) No 655/2013. laying down common criteria for the justification of claims used
Ref. Ares(2015)5892153-16/12/2015 Version July 2013 Guidelines to Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products
More informationResearch on the Administrative Rules of APIs, Pharmaceutical Excipients and Auxiliary Materials Master File. Translation version
Research on the Administrative Rules of APIs, Pharmaceutical Excipients and Auxiliary Materials Master File Division of Pharmaceuticals Department of Drug Registration Hou Renping Translation version Main
More informationThe EU PIP - a step in Pediatric Drug Development. Thomas Severin Bonn,
The EU PIP - a step in Pediatric Drug Development Thomas Severin Bonn, 13.01.2009 Agenda Implications for Industry Company Preparation Time of PIP Submission Content of the PIP The PIP Process and first
More informationEMEA WORKING PARTY ON HERBAL MEDICINAL PRODUCTS
The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use 25 October 1999 EMEA/HMPWP/23/99 EMEA WORKING PARTY ON HERBAL MEDICINAL PRODUCTS UPDATED DRAFT POINTS
More informationA GUIDELINE ON CHANGING THE CLASSIFICATION FOR THE SUPPLY OF A MEDICINAL PRODUCT FOR HUMAN USE
EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals Revision January 2006 A GUIDELINE ON CHANGING THE CLASSIFICATION FOR THE SUPPLY OF A MEDICINAL PRODUCT FOR
More informationThis Administrative regulation will come into force on 1 st January 2018 and will remain so until further notice. Administrative Regulation No 3/2015
Administrative regulation 15.12.2017 Dnro 007313/00.01.02/2017 02/2017 UNOFFICIAL TRANSLATION Finnish Medicines Agency Administrative Regulation APPLYING FOR AND MAINTAINING A MARKETING AUTHORI- SATION
More informationThis Administrative regulation will come into force on 1 st August 2013 and will remain so until further notice.
Administrative regulation 01.08.2013 Dnro 4000/03.01.01/2012 2/2013 UNOFFICIAL TRANSLATION Finnish Medicines Agency Administrative Regulation APPLYING FOR AND MAINTAINING A MARKETING AUTHORI- SATION AND
More informationThis document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
2007R1394 EN 02.07.2012 001.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B REGULATION (EC) No 1394/2007 OF THE EUROPEAN
More informationGuideline on influenza vaccines submission and procedural requirements
1 2 3 October 2014 EMA/56793/2014 Human Medicines Research and Development Support 4 5 6 Guideline on influenza vaccines submission and procedural requirements Regulatory and procedural requirements module
More informationSupport to paediatric medicines development
Support to paediatric medicines development SME Info day Supporting innovative medicines development and early access Presented by Rocio Fernandez Human Medicines Research & Development Support Division
More informationBILATERAL SCREENING MEETING
Negotiating Group for the Accession of the Republic of Serbia to the European Union - Chapter 28, Consumer and Health Protection BILATERAL SCREENING MEETING Chapter 28 Consumer and Health Protection Brussels,
More informationAdopted by CVMP 10 March Date for coming into effect 1 July Revised draft guideline agreed by Immunologicals Working Party 22 June 2017
1 2 3 7 September 2017 EMA/CVMP/IWP/105506/2007-Rev.1 Committee for medicinal products for veterinary use (CVMP) 4 5 6 7 Guideline on data requirements for multi-strain dossiers for inactivated vaccines
More informationMOTION FOR A RESOLUTION
EUROPEAN PARLIAMT 2009-2014 Plenary sitting 07.3.2012 B7-0000/2012 MOTION FOR A RESOLUTION further to Question for Oral Answer B7-0000/2012 pursuant to Rule 115(5) of the Rules of Procedure on Defective
More informationAnnex II - List of enforceable provisions of REACH and CLP
Annex II - List of enforceable provisions of REACH and CLP The provisions below are listed according to the sections of the main report, together with the Titles of the Regulation in the case of REACH.
More informationOverview of the Procedure and interactions between CAT and CHMP
1 st Workshop on Advance Therapy Medicinal Products (ATMPs) Overview of the Procedure and interactions between CAT and CHMP Marie-Helene Pinheiro EMEA Regulatory Affairs Insert your logo in this area then
More informationRISK MANAGEMENT OPTION ANALYSIS CONCLUSION DOCUMENT
RISK MANAGEMENT OPTION ANALYSIS CONCLUSION DOCUMENT for Substance name: 2,4,6-trimethyl-2,4,6-tris(3,3,3- trifluoropropyl)cyclotrisiloxane, F-D3 EC number: 219-154-7 CAS number: 2374-14-3 Member State(s):
More informationGuideline on the processing of renewals in the centralised procedure
14 July 2016 Committee for Human Medicinal Products (CHMP) Guideline on the processing of renewals in the centralised procedure Transmission to CPMP November 2000 Release for consultation December 2000
More informationCOUNCIL OF THE EUROPEAN UNION. Brussels, 7 September 2009 (OR. en) 11261/09 Interinstitutional File: 2008/0002 (COD) DENLEG 51 CODEC 893
COUNCIL OF THE EUROPEAN UNION Brussels, 7 September 2009 (OR. en) 11261/09 Interinstitutional File: 2008/0002 (COD) DLEG 51 CODEC 893 LEGISLATIVE ACTS AND OTHER INSTRUMTS Subject: Common Position with
More informationC 178/2 Official Journal of the European Union
C 178/2 Official Journal of the European Union 29.7.2003 Communication from the Commission on Regulation (EC) No 141/2000 of the European Parliament and of the Council on orphan medicinal products (2003/C
More informationWorking Document prepared by the Commission services - does not prejudice the Commission's final decision 3/2/2014 COMMISSION STAFF WORKING DOCUMENT
COMMISSION STAFF WORKING DOCUMENT on certain requirements for FSMPs [Supporting Document for the Expert Group meeting of 7 February 2014] Introduction Following the discussions in the Expert Group meeting
More informationSTATUTORY INSTRUMENTS. S.I. No. 531 of 2018 HEALTH PRODUCTS REGULATORY AUTHORITY (FEES) (NO. 2) REGULATIONS 2018
STATUTORY INSTRUMENTS. S.I. No. 531 of 2018 HEALTH PRODUCTS REGULATORY AUTHORITY (FEES) (NO. 2) REGULATIONS 2018 2 [531] S.I. No. 531 of 2018 HEALTH PRODUCTS REGULATORY AUTHORITY (FEES) (NO. 2) REGULATIONS
More informationIMPORTANT DISCLAIMER. Note
yn EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL June 2012 DRAFT GUIDANCE DOCUMENT FOR COMPETENT AUTHORITIES FOR THE CONTROL OF COMPLIANCE WITH EU LEGISLATION ON: Regulation (EU) No 1169/2011
More informationMedication errors. Impact of medication error guidance and regulation on drug-device combination products. June 2017 Dan Wozinski
Medication errors Impact of medication error guidance and regulation on drug-device combination products June 2017 Dan Wozinski Agenda Understand the management of medication errors within global requirements
More informationNOTICE TO APPLICANTS
EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Food and feed safety, innovation Animal nutrition, veterinary medicines NOTICE TO APPLICANTS VETERINARY MEDICINAL PRODUCTS VOLUME 6A Procedures
More informationMedical Devices. BARBADOS Clarke Gittens Farmer
Medical Devices BARBADOS Clarke Gittens Farmer CONTACT INFORMATION Danielle Maycock Clarke Gittens Farmer Parker House, Wildey Business Park Wildey Road, St. Michael, Barbados Tel. 246.436.6287 rsm@clarkes.com.bb
More informationDefinition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 Consultation document Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs) Recommendations
More informationCOMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC)
European Medicines Agency Post-authorisation Evaluation of Medicines for Human Use London, 7 September 2006 Doc. Ref. EMEA/HMPC/104613/2005 COMMITTEE ON HERBAL MEDICINAL PRODUCTS (HMPC) GUIDELINE ON THE
More informationEUROPEAN UNION. Brussels, 15 October 2007 (OR. en) 2005/0227 (COD) PE-CONS 3627/07 MI 149 ECO 83 SAN 123 CODEC 621
EUROPEAN UNION THE EUROPEAN PARLIAMT Brussels, 15 October 2007 (OR. en) THE COUNCIL 2005/0227 (COD) PE-CONS 3627/07 MI 149 ECO 83 SAN 123 CODEC 621 LEGISLATIVE ACTS AND OTHER INSTRUMTS Subject: Regulation
More informationMeeting of the EU GLP Working Group, February GLP requirements in EU legislation and guidance medical devices
Meeting of the EU GLP Working Group, 22-23 February 2017 Agenda item: Document title: Action required: Session 2, item 2a GLP requirements in EU legislation and guidance medical devices Requirements of
More informationChanging practice to support service delivery
Nurse and Midwife Medicinal Product Prescribing Toolkit Authorised Medicinal Products, Off-label Prescription and Exempt Medicinal Products Toolkit Changing practice to support service delivery Introduction
More informationThe Paediatric Committee (PDCO)
www.eurordis.org The Paediatric Committee (PDCO) Fernando de Andres-Trelles (UCM, PDCO, AEMPS) Barcelona, June 2013 1 Some of the slides based on EMA sources, gratefully acknowledged* but opinions are
More informationGeneral Concepts in the European Pharmacopoeia. Anne-Sophie Bouin European Pharmacopoeia Department, EDQM, Council of Europe
General Concepts in the European Pharmacopoeia Anne-Sophie Bouin European Pharmacopoeia Department, EDQM, Council of Europe General notices Anne-Sophie Bouin, 28/10/09 2009 EDQM, Council of Europe, All
More informationFoodDrinkEurope Position on GLP studies
FoodDrinkEurope Position on GLP studies Content of the presentation Introduction to GLP Importance of GLP for the food industry Use of GLP based on the example of novel foods Conclusions GLP what is it?
More informationSurvey results - Analysis of higher tier studies submitted without testing proposals
Survey results - Analysis of higher tier studies submitted without testing proposals Submission of higher tier studies on vertebrate animals for REACH registration without a regulatory decision on testing
More informationREPORT ON THE 9TH JOINT CROSS-BORDER EMC MARKET SURVEILLANCE CAMPAIGN (2017) E-cigarettes. Final
REPORT ON THE 9TH JOINT CROSS-BORDER EMC MARKET SURVEILLANCE CAMPAIGN (2017) E-cigarettes Final Contents A. Executive summary... 3 B. Elements of the Campaign... 4 1. Introduction... 4 2. Reasons for the
More informationGUIDE FOR THE NEW ELECTRONIC PAYMENT SYSTEM. Version 1.0 Spanish Agency of Medicines and Medical Devices
GUIDE FOR THE NEW ELECTRONIC PAYMENT SYSTEM Version 1.0 Spanish Agency of Medicines and Medical Devices NEW ELECTRONIC PAYMENT SYSTEM INTRODUCTION AND ENTRY TO THE SYSTEM DEPARTMENT OF MEDICINES FOR HUMAN
More informationDraft Agreed by Immunologicals Working Party January Adoption by CVMP for release for consultation 12 March 2009
15 March 2010 EMA/CVMP/IWP/105506/2007 Committee for medicinal products for veterinary use (CVMP) Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza
More informationEUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL. PHARMACEUTICAL COMMITTEE 21 October 2015
EUROPEAN COMMISSION HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL Health systems and products Medicinal products authorisations, European Medicines Agency PHARM 689 PHARMACEUTICAL COMMITTEE 21 October 2015
More information(Legislative acts) REGULATIONS
31.12.2010 Official Journal of the European Union L 348/1 I (Legislative acts) REGULATIONS REGULATION (EU) No 1235/2010 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2010 amending, as regards
More informationThe European Union CD 1999/83/EEC on well-established use
The European Union CD 1999/83/EEC on well-established use - application to herbal medicinal products - Dr. Konstantin Keller Chair of the Herbal Medicinal Products Working Group European Medicines Evaluation
More informationRegulation 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 informationCHAPTER 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 informationCOMMISSION OF THE EUROPEAN COMMUNITIES. Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
EN EN EN COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 10.12.2008 COM(2008) 664 final 2008/0257 (COD) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending, as regards pharmacovigilance
More informationBEST PRACTICE CHANGE CONTROL : DECIDING WHEN TO SUBMIT A 510(K) FOR A DEVICE CHANGE. Yuan Xu 18- JAN- 2018
BEST PRACTICE CHANGE CONTROL : DECIDING WHEN TO SUBMIT A 510(K) FOR A DEVICE CHANGE Yuan Xu 18- JAN- 2018 Background AGENDA What is Medical Device? What is 510(k)? Principles of best practices of device
More informationMarket surveillance of medical devices
Market surveillance of medical devices A joint action on market surveillance of medical devices to reinforce public health protection Information for healthcare professionals Introduction The European
More informationHolders of European Union marketing authorizations
PRAC Experience The legal framework The Pharmacovigilance legislation (Regulation No 1235/2010 and Directive 2010/84/EU) was adopted by the European Parliament and European Council in December 2010. The
More informationATMPs & 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 informationDIRECTIVE 2004/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL. of 31 March 2004
30.4.2004 Official Journal of the European Union L 136/85 DIRECTIVE 2004/24/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 31 March 2004 amending, as regards traditional herbal medicinal products,
More informationDiabetes Management in hospital care: GlucoTab - A medical device to improve insulin treatment of patients with diabetes type 2
Diabetes Management in hospital care: GlucoTab - A medical device to improve insulin treatment of patients with diabetes type 2 JOANNEUM RESEARCH Forschungsgesellschaft mbh HEALTH Institute for Biomedicine
More informationMEDICINES, MEDICAL DEVICES, TREATMENTS AND HEALTH
11 MEDICINES, MEDICAL DEVICES, TREATMENTS AND HEALTH Background The rules in this section are designed to ensure that advertisements that include health claims (please see Section 13 for health claims
More informationThis is an unofficial English translation of the Royal Decree 1344/2007 revised by the Spanish Agency for Medicines and Medical Devices
agencia española de medicamentos y productos sanitarios This is an unofficial English translation of the Royal Decree 1344/2007 revised by the Spanish Agency for Medicines and Medical Devices ROYAL DECREE
More informationStandard Operating Procedure. Selection of studies performed in compliance with Good Laboratory Practice for audit purposes
Scope To describe the procedure for EFSA to request on a yearly or ad-hoc basis the performance of GLP studies audits by the GLP Monitoring Authorities. To lay down criteria for the selection of the GLP
More informationHerbal 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 informationMedical Devices and Active Implantable Medical Devices
Medical Devices and Active Implantable Medical Devices Exclusion Interpretation Guide MD e IAMD ANREEE October 2016 This document aims to clarify in what circumstances certain equipment can be considered
More informationWyss Zürich Regulatory Affairs Seminar
Wyss Zürich Regulatory Affairs Seminar Hospital Exemption & Compassionate Use EU Framework Catherine Longeval Koen T Syen Zürich, 5 July 2017 1 Table of contents Introduction Hospital Exemption Implementation
More informationIntroducing BSI. BSI Medical Device Regulatory Update Galway, Ireland. Dr. Michael Weissig EMEA Vice President Healthcare 26 June, 2015
Introducing BSI BSI Medical Device Regulatory Update Galway, Ireland Dr. Michael Weissig EMEA Vice President Healthcare 26 June, 2015 Copyright 2014 BSI. All rights reserved. Global Healthcare Mission
More informationThe Paediatric Regulation a perspective from the European Medicines Agency
The Paediatric Regulation a perspective from the European Medicines Agency Dr Edith La Mache EMEA Current paediatric situation 20% of the EU population, i.e. 100 million, is aged less than 16 years premature
More informationCHE8000 Major Research Project A. The Complementary Medicines Reforms and Its Impact to the Complementary Medicine Industry and the Consumer
CHE8000 Major Research Project A The Complementary Medicines Reforms and Its Impact to the Complementary Medicine Industry and the Consumer Completed by: Lina Karlina (ID: 2067226) Lina Karlina (2067226)
More informationResponse to: Concept paper of 9 February 2011 submitted for public consultation by the European Commission on the
Response to: Concept paper of 9 February 2011 submitted for public consultation by the European Commission on the REVISION OF THE CLINICAL TRIALS DIRECTIVE 2001/20/EC Submitted by the European AIDS Treatment
More informationRecall Guidelines. for Chinese Medicine Products
Recall Guidelines for Chinese Medicine Products April 2018 Recall Guidelines for Chinese Medicine Products Chinese Medicines Board Chinese Medicine Council of Hong Kong Compiled in September 2005 1 st
More informationGuideline on good pharmacovigilance practices (GVP)
19 April 2013 EMA/169546/2012 Guideline on good pharmacovigilance practices (GVP) Module X Additional monitoring Draft finalised by the Agency in collaboration with Member States 25 May 2012 Draft agreed
More informationCOMMISSION REGULATION (EU)
11.3.2011 Official Journal of the European Union L 64/15 COMMISSION REGULATION (EU) No 234/2011 of 10 March 2011 implementing Regulation (EC) No 1331/2008 of the European Parliament and of the Council
More informationMedical Devices. SOUTH AFRICA Bowman Gilfillan
Medical Devices SOUTH AFRICA Bowman Gilfillan CONTACT INFORMATION Llewellyn Parker Bowman Gilfillan PO Box 785812, Sandton, 2146 South Africa +27 11 669 9635 l.parker@bowman.co.za www.bowman.co.za 1. Definition
More informationREGULATION (EC) No.141/2000
REGULATION (EC) No.141/2000 Community legislation in force Document 300R0141 Directory chapters where this document can be found: [15.30 Health promotion] Regulation (EC) No.141/2000 of the European Parliament
More informationCE-marking of Medical Devices and complete Medical Gas Pipeline Systems (MGPS) Holsterbro Sygehus - Denmark
CE-marking of Medical Devices and complete Medical Gas Pipeline Systems (MGPS) 180827 Holsterbro Sygehus - Denmark Johan Arnfelt Marketing & Bus Dev Mngr, Linde Healthcare EMEA Agenda - My background -
More informationManufacture of Medical Devices within Healthcare Institutions A GUIDANCE NOTE FROM THE IRISH MEDICINES BOARD
Manufacture of Medical Devices within Healthcare Institutions A GUIDANCE NOTE FROM THE IRISH MEDICINES BOARD PREFACE GUIDANCE NOTE ON THE MANUFACTURING OF MEDICAL DEVICES WITHIN HEALTHCARE INSTITUTIONS
More informationREGULATION concerning Marketing Authorisations for Natural Medicinal Products and Registration of Traditional Herbal Medicinal Products, No. 142/2011.
REGULATION concerning Marketing Authorisations for Natural Medicinal Products and Registration of Traditional Herbal Medicinal Products, No. 142/2011. CHAPTER I Scope and definitions. Article 1 Scope.
More informationProcedural advice on the submission of variations for annual update of human influenza inactivated vaccines applications in the centralised procedure
1 2 3 4 5 6 7 8 9 14 April 2010 EMA/CHMP/BWP/99698/2007 Rev. 1 Committee for Medicinal Products for Human Use (CHMP) Procedural advice on the submission of variations for annual update of human influenza
More informationGuidance for Industry
MEDICAL DEVICES SECTOR Guidance for Industry Format and Content of Proposed Bundling/Grouping Criteria for Medical Devices DRAFT GUIDANCE This guidance document is being distributed for comment purposes
More informationCommission. 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
More informationOFFICIAL STATE BULLETIN
No. 280 Saturday 18 November 2017 Sec. I. Page 111191 I. GENERAL PROVISIONS HEAD OF STATE 13277 Royal Decree-Law 17/2017, of 17 November, amending Law 28/2005, of 26 December, on health measures against
More informationPharmaceutical Trade Marks
1 Pharmaceutical Trade Marks September 2015 Ben Mooneapillay bmooneapillay@jakemp.com www.jakemp.com C 22 H 30 N 6 O 4 S C 26 H 44 N 2 O 10 S sildenafil citrate salbutamol sulphate Badge of Origin Quality
More informationReports of Cases OPINION OF ADVOCATE GENERAL SHARPSTON 1. delivered on 30 May Laboratoires Lyocentre
Reports of Cases OPINION OF ADVOCATE GENERAL SHARPSTON 1 delivered on 30 May 2013 Case C-109/12 Laboratoires Lyocentre (Request for a preliminary ruling from the Korkein hallinto-oikeus (Finland)) (Medicinal
More informationDecentralised 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 informationCHAPTER 4 POST-MARKETING SURVEILLANCE OF DRUGS
CHAPTER 4 POST-MARKETING SURVEILLANCE OF DRUGS Post-marketing surveillance (PMS) to assure the quality, efficacy and safety of drugs after they go on the market and to establish proper methods of use of
More informationORDER of the Minister of Health No. 269/2017 of 14 March 2017 on mandatory provision of medicinal product adequate and continuous supplies
ORDER of the Minister of Health No. 269/2017 of 14 March 2017 on mandatory provision of medicinal product adequate and continuous supplies ISSUING BODY: The Ministry of Health published in: the Official
More information