PLANT PROTECTION DIRECTORATE. Department for Plant Protection (PPP`s) and Plant Nutrition Products (PNP`s) MUTUAL RECOGNITION
|
|
- Dwain Dawson
- 6 years ago
- Views:
Transcription
1 Republic of Serbia Ministry of Agriculture, Forestry and Water Management PLANT PROTECTION DIRECTORATE Plant Protection (PPP`s) and Plant Nutrition Products (PNP`s) MUTUAL RECOGNITION Omladinskih brigada 1, Novi Beograd
2 COMPETENCES BEFORE ADOPTION OF THE NEW LAW MINISTRY OF ENVIRONMENT AND SPATIAL PLANNING MINISTRY OF AGRICULTURE, FORESTRY AND WATER MANAGEMENT Registration file Authorised scientific institutes Toxicological opinion MINISTRY OF HEALTH Registration file Ministry and Authorised scientific institutes Toxic Substances Committee Classification and Labelling MRL Committee MRL List of MRL physical and chemical properties, efficacy tests Plant Protection Committee recommendation List of Toxic Substances final authorization permission MAFWM PPP`s List
3 MAFWM- PPD efficacy Proposal Dossiers MAFWM-PPD Completeness check Coordination EVALUATION Plant Protection Committee Proposal + Agency for Chemicals NATIONAL REFERENCE LABORATORY Postregistration control (residues, formulations) Authorized Scientific Institutions Phys/chem, Fate & Behaviour, Ecotox., Mammalian toxicology Residues/MRL consideration Operator exposure Proposal final authorization MAFWM - PPD List of PPP`s
4 THE LAW ON PLANT PROTECTION PRODUCTS harmonised with Directive 91/414/EEC (articles 1-23) without provisions for Parallel import basic provision new Regulation and other future framework legislation (Directive sustainable use of pesticides, Regulation concerning statistics on PPP`s) Annexes of the Directive 91/414/EEC (I-VI), Directive 79/117/EEC, Directive on the sustainable use of pesticides, Regulation concerning statistics on PPP`s will be completely transposed in the secondary legislation by laws. Classification, packaging and labelling of PPP`s pursuant to the Act on Chemicals and the subsequent regulations implementing DPD + Rules on Labelling (Annexes IV and V Directive 91/414/EEC ) MAFWM
5 REGISTRATION WILL TAKE PLACE IN TWO PHASES: 1.Re-registration of existing PPP`s: Will apply since 31/12/2013 (Article 11 to 25 of the Law - registration procedure according to Dir. 91/414) -capacity building RS for full implementation of the law (assessment of active substances and PPP`s) -capacity building of interested parties to compile registration documents 2. Registration of new PPP`s according to the Law on Plant Protection and the Law on production and market of toxic substances - criteria relating to necessary documentation will be define ACCEPT Annex I of Directive 41/414, EU harmonised MRL Problem: Access to the DAR
6 OLD SYSTEM Article Rules on pesticide testing methods Criteria: - List on minor uses - PPP`s registered in Serbia - PPP`s registered in one of the EU Member State, Switzerland for national minor uses NEW SYSTEM Article 16 PPP`s law (Article 10 Par. 1 Dir. 91/414) Will apply since 31/12/2013 Authorization for 5 years ONE CASE SELECT SUPER
7 Organizational Scheme of the PPD (valid since till ) Plant Health and Quarantine Plant Protection and Plant Nutrition Products Phytosanitary Inspection Section for legal, financial and general operations Coordination (2 p) Border Section Lawyers (2 p) Efficacy, physical and chemical properties PPP`s and PNP`s (5 p) Ecotoxicology of PPP`s (1 p) Fate and behaviour of PPP`s (1 p) Toxicology and MRL of PPP`s (1 p) Quality and efficacy of PPP`s application equipment (1 p) Section North Section Belgrade Section Centar Section West Section South Economists (3 p)
8 Organizational Scheme of the PPD (valid since ) Director Plant Health and Quarantine PPP`s and PNP`s plant variety registration Section for plant variety protection, genetically resources and biological safety Phytosanitary Inspection Section for certification of seeds and planting material Group for legal, financial and general operations Coordination (2 p) Efficacy, physical and chemical properties PPP`s and PNP`s (5 p) Ecotoxicology (1 p) Fate and behavior (1 p) Toxicology and MRL (1 p) Application equipment (1 p) Phytosanitary Inspection Border Section Section North Section Belgrade Section Centar Section West Section South Border Section Section North Section Belgrade Section Centar Section West Section South General Inspectorate Veterinary Inspection Forestry Inspection Quality Inspection Water Inspection Lawyers (2 p) Economists (3 p)
9 Contact SNEZANA SAVCIC-PETRIC Head of the Plant Protection and Plant Nutrition Products www. minpolj.gov.rs
10 THANK YOU FOR ATTENTION
Progress Report on the Implementation of PPPs Regulations in Republic of Croatia CEUREG FORUM XVIII MEETING
Progress Report on the Implementation of PPPs Regulations in Republic of Croatia MEETING Congress Centre Hotel IOR, Poznań, Poland 16th-17th October 2014 Organization of national competent authority Report
More informationGuidance on the application of mutual recognition in Norway
Guidance on the application of mutual recognition in Norway Under regulation (EC) No. 1107/2009 Norwegian Food Safety Authority Region Office, Greater Oslo Region Official in charge: Tor Erik Jørgensen
More informationVeterinary Medicines Legislation and Maximum Residue Limits in the EU
OIE Belgrade, 26 July 2010 Veterinary Medicines Legislation and Maximum Residue Limits in the EU Mario Nagtzaam EC, DG SANCO, Unit C8 Pharmaceuticals Outline Institutions of the European Union European
More information(Acts whose publication is obligatory) DIRECTIVE 98/8/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL. of 16 February 1998
EN Official Journal of the European Communities L 123/1 I (Acts whose publication is obligatory) DIRECTIVE 98/8/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 February 1998 concerning the placing
More informationSarajevo April Regional Workshop on Implementation of Phytosanitary Standards in Forestry PLANT PROTECTION DIRECTORATE
Sarajevo 15-18 April 2013 Regional Workshop on Implementation of Phytosanitary Standards in Forestry PLANT PROTECTION DIRECTORATE Plant Health and Plant Quarantine Department Lidija Ristić-Matijević To
More informationImplementation of toxicological data from other legal provisions (e.g. REACH) An industry perspective
Implementation of toxicological data from other legal provisions (e.g. REACH) An industry perspective Dr. Christopher Dobe BfR workshop, Berlin 24 th November 2017 christopher.dobe@syngenta.com Overview
More informationAustria: Experiences with the Zonal evaluation procedure Applying Regulation (EC) No.1107/2009
Austria: Experiences with the Zonal evaluation procedure Applying Regulation (EC) No.1107/2009 Vienna, Ceureg Meeting, 15-16 October 2012 Rebecca Reboul Institute for Plant Protection Products AGES, Austrian
More informationImport tolerances in the European Union Can Import Tolerances be set for active substances impacted by the EU hazard-based criteria?
Import tolerances in the European Union Can Import Tolerances be set for active substances impacted by the EU hazard-based criteria? May 2017 Abstract The aim of this paper is to provide information on
More informationRisk assessment: the bees (including a personal point of view from a private beekeeper)
Risk assessment: the bees (including a personal point of view from a private beekeeper) J. Pistorius (JKI) Bees in the Institute for Plant Protection in Field Crops and Grassland I. Risk assessment of
More informationExplanatory note on general fees payable to the European Medicines Agency
Explanatory note on general fees payable to the European Medicines Agency The fees, fee exemptions and definitions described in this explanatory note apply as of 1 June 2017 and are based on Council Regulation
More informationThe rules governing medicinal products in the European Union. Presentation and content of the dossier Edition
The rules governing medicinal products in the European Union Volume 2B Notice to Applicants Medicinal products for human use Presentation and content of the dossier 1998 Edition EUROPEAN COMMISSION Directorate
More informationGUIDANCE DOCUMENT ON WORK-SHARING IN THE NORTHERN ZONE IN THE AUTHORISA- TION OF PLANT PROTECTION PRODUCTS
GUIDANCE DOCUMENT ON WORK-SHARING IN THE NORTHERN ZONE IN THE AUTHORISA- TION OF PLANT PROTECTION PRODUCTS Version 6.0. This guidance document replaces the version of April 2016 and can be voluntarily
More informationCOUNCIL DIRECTIVE of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC) (OJ L 230, , p.
1991L0414 EN 01.02.2007 016.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B COUNCIL DIRECTIVE of 15 July 1991 concerning
More informationRADIATION PROTECTION
Republic of Serbia Negotiating Group on Energy BILATERAL SCREENING MEETING Examination of the Preparedness of Serbia in the field of Chapter 15 Energy Sectoral framework Nuclear energy RADIATION PROTECTION
More informationFood and Agricultural Import Regulations and Standards - Narrative
Required Report - public distribution Date: 7/27/2009 GAIN Report Number: RB9007 Serbia Food and Agricultural Import Regulations and Standards - Narrative FAIRS Country Report Approved By: Hoa Van Huynh
More informationRepublic of Serbia Negotiating Group on Transport BILATERAL SCREENING MEETING. Chapter 14: Transport Policy Dangerous goods
Republic of Serbia Negotiating Group on Transport BILATERAL SCREENING MEETING Chapter 14: Transport Policy Dangerous goods Brussels, 24-26 EUROPEAN DIRECTIVE Directive 2008/68/EC of the European Parliament
More information12 Food safety, veterinary and phytosanitary policy. Questionnaire
Government of Montenegro 12 Food safety, veterinary and phytosanitary policy Ministry of Agriculture, Forestry and Water Management Questionnaire Information requested by the European Commission to the
More informationSeminar on «EU Plant Health
Seminar on «EU Plant Health Requirements» Bangkok, 21 October 2011 Quick view on the EU pesticide residue legislation Dionyssis Vlachos Dionyssis Vlachos Ministry of Rural Development and Food, Greece
More informationACVM - REGISTRATION STANDARD FOR TOXICOLOGY AND ENVIRONMENTAL TOXICOLOGY
ACVMS 9.1 Ministry of Agriculture and Forestry Post Office Box 2526 WELLINGTON, NEW ZEALAND ACVM - REGISTRATION STANDARD FOR TOXICOLOGY AND ENVIRONMENTAL TOXICOLOGY This document may be altered at any
More informationDISCOVER OUR SEGMENT REGULATORY SCIENCE
DISCOVER OUR SEGMENT REGULATORY SCIENCE Our focus In the demanding regulatory environment of the EU, expert knowledge is essential to gaining approval for substances and products. That is why the scientific
More informationCurrent activities of the European Commission in the area of pesticide residues
4th Joint Workshop of the European Union Reference Laboratories - 23rd - 25th October 2013 Current activities of the European Commission in the area of pesticide residues Veerle Vanheusden Introduction
More informationA Global CRO STRONGER TOGETHER
A Global CRO STRONGER TOGETHER About us Unique Service Offering the first agrochemical CRO to offer a truly global service Part of the Eurofins Scientific Group of companies, Eurofins Agroscience Services
More informationVETERINARY AND PHYTOSANITARY MATTERS
27.10.2017 - EEA AGREEMENT- ANNEX I p. 1 { 1 } ANNEX I VETERINARY AND PHYTOSANITARY MATTERS TABLE OF CONTENTS I. Veterinary Issues II. Feedingstuffs III. Phytosanitary Matters List provided for in Article
More informationJustification Document for the Selection of a CoRAP Substance - Update -
_ Justification Document for the Selection of a CoRAP Substance - Update - Substance Name (public name): Tetradecahydro-7-isopropyl-1,4adimethylphenanthren-1-methanol EC Number: 236-476-3 CAS Number: 13393-93-6
More information(EFSA-Q ) 1 For the purpose of this document foods of animal origin are limited to fresh unprocessed products of animal origin.
1 2 3 4 5 6 7 8 9 10 Joint AFC/BIOHAZ draft guidance document on the submission of data for the evaluation of the safety and the efficacy of substances other than potable water intended to be used to decontaminate
More informationTechnical Notes for Guidance on. Dossier Preparation including preparation and evaluation of study summaries
Technical Notes for Guidance on Dossier Preparation including preparation and evaluation of study summaries under Directive 98/8/EC Concerning the Placing of Biocidal Products on the Market 28 March 2002
More informationRegulatory framework for seed treatments in the EU
Pesticide risks for pollinators 8th SETAC Europe Special Science Symposium Brussels, 16-17 October 2013 Regulatory framework for seed treatments in the EU Gunilla Ericson European Commission Directorate
More informationWork plan for the GMP/GDP Inspectors Working Group for 2017
13 January 2017 EMA/INS/GMP/584202/2016 Work plan for the GMP/GDP Inspectors Working Group for 2017 Chairperson: David Cockburn Adopted: December 2016 1. Meetings scheduled for 2017 Face-to-face meetings
More informationREACH REGULATION: the new management of chemicals in Europe and operational tools. R egistration. E valuation. A Ch. uthorisation.
REACH REGULATION: the new management of chemicals in Europe and operational tools R egistration E valuation A Ch uthorisation emicals Index of topics Set of rules before REACH Regulation REACH REGULATION
More informationCIRCULAR GUIDING ON THE FOOD HYGIENE AND SAFETY CONTROL FOR IMPORTED FOODSTUFFS OF ANIMAL ORIGIN
Unofficial translation MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT No. 25/2010/TT-BNNPTNT SOCIALIST REPUBLIC OF VIET NAM Independence - Freedom Happiness Hanoi, April 8, 2010 CIRCULAR GUIDING ON THE
More informationBilateral screening: Chapter 27 PRESENTATION OF THE REPUBLIC OF SERBIA DIRECTIVE 2000/53/EC on end-of life vehicles
REPUBLIC OF SERBIA Negotiating Group for the Chapter 27, and Climate Change Bilateral screening: Chapter 27 PRESENTATION OF THE REPUBLIC OF SERBIA DIRECTIVE 2000/53/EC on end-of life vehicles Department
More informationOrganisation de Coopération et de Développement Économiques Organisation for Economic Co-operation and Development
Unclassified ENV/JM/MONO(2012)12 ENV/JM/MONO(2012)12 Unclassified Organisation de Coopération et de Développement Économiques Organisation for Economic Co-operation and Development 23-May-2012 English
More information10041/16 ADD 1 GSC/lt 1 DG B 2B
Council of the European Union Brussels, 10 June 2016 (OR. en) 10041/16 ADD 1 AGRI 320 PHYTOSAN 12 PESTICIDE 1 NOTE From: To: Subject: Presidency Delegations Acceleration of Sustainable Plant Production
More informationEUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY. EudraLex. Volume 4
EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Ref. Ares(2015)4234460-12/10/2015 Medicinal products quality, safety and efficacy Brussels, 12 October 2015 EudraLex Volume 4 EU Guidelines
More informationENFORCEMENT 9/16. Annual Report on control measures according to Article 68 of Regulation (EC) No. 1107/2009. kemikalieinspektionen.se.
Annual Report on control measures according to Article 68 of Regulation (EC) No. 1107/2009 Sweden 2015 ENFORCEMENT 9/16 kemikalieinspektionen.se The Swedish Chemicals Agency is supervisory authority under
More informationmechanism. GMP certificates Belén Escribano, PhD Head of the Pharmaceutical Inspection and Enforcement Department of AEMPS
Mutual recognition: basic aspects and mechanism. GMP certificates Belén Escribano, PhD Head of the Pharmaceutical Inspection and Enforcement Department of AEMPS The EU network of medicines agencies 31
More informationPolgar ACRO Registration of Pesticides in Russia and Ukraine: Applicants feedback
Polgar ACRO Registration of Pesticides in Russia and Ukraine: Applicants feedback p.tatsiana@polgar-acro.eu Contents Who we are Introduction: Ukraine Overview: timing, steps Costs Authorities and institutions
More information- A6/18 - Format for the listing of test and study reports and other documentation PART 4
- A6/18 - PART 4 OECD, EU, US, CANADIAN, JAPANESE AND AUSTRALIAN NUMBERING SYSTEMS FOR DATA AND INFORMATION ON PHEROMONE AND OTHER SEMIOCHEMICAL ACTIVE SUBSTANCES 1. As indicated in subparagraph 3.1.1
More informationSingle market, implementation and legislation for consumer goods Pharmaceuticals : regulatory framework and market authorisations.
EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market, implementation and legislation for consumer goods Pharmaceuticals : regulatory framework and market authorisations Brussels, March 2002
More informationLAW ON PLANT PROTECTION PRODUCTS I BASIC PROVISIONS. Article 1
LAW ON PLANT PROTECTION PRODUCTS I BASIC PROVISIONS Article 1 This Law shall govern manner of classification, registration, trade and use of plant protection products and active substances, maximum permitted
More informationECHA 1(7) Helsinki, 19 May 2014
1(7) Helsinki, 19 May 2014 Decision/annotation number: Please refer to the REACH-IT message which delivered this communication ( in format SEV-D-XXXXXXXXXX-XX-XX/F) DECISION ON SUBSTANCE EVALUATION PURSUANT
More informationImpact of the transposition of the European Clinical Trials Directive. CEMO, Paris 17 November 2004
Impact of the transposition of the European Clinical Trials Directive CEMO, Paris 17 November 2004 Dr Martine Dehlinger-Kremer VP Regulatory Affairs International Agenda Overview of key areas of Directive
More informationThe Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) Background and Coverage
The Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) Background and Coverage Uruguay Round: Negotiations on Agriculture Objectives to eliminate quantitative import restrictions
More informationAuthorisation procedure for plant protection products. Description of the procedure for applications for zonal authorisations in Germany
Authorisation procedure for plant protection products Description of the procedure for applications for zonal authorisations in Germany Contact address: Bundesamt für Verbraucherschutz und Lebensmittelsicherheit
More informationLAW OF GEORGIA ON PESTICIDES AND AGROCHEMICALS (Last amended as of may 7, 2003, #2182)
LAW OF GEORGIA ON PESTICIDES AND AGROCHEMICALS (Last amended as of may 7, 2003, #2182) CHAPTER I GENERAL PROVISIONS Article 1. Purpose of the Law and Scope of Regulation 1. The purpose of this Law is to
More informationDi Renzo Regulatory Affairs ROME - MILAN - LONDON
Di Renzo Regulatory Affairs ROME - MILAN - LONDON Di Renzo Regulatory Affairs In 1985, Di Renzo Regulatory Affairs began its regulatory consulting for medicines for human and veterinary use, food and dietary
More informationInformation, test or study provided Y/P/N #
- A11/20 - Part 4 Evaluation Form 4 - for use in checking that all test and study reports required in accordance with Annex IIIP have been Preparation: Active substance(s): PHEROMONE Applicant: Date: APRIL
More informationCOMMISSION IMPLEMENTING REGULATION (EU) /... of XXX
EUROPEAN COMMISSION Brussels, XXX SANTE/10440/2017 Rev. 2 [ ](2017) XXX draft COMMISSION IMPLEMENTING REGULATION (EU) /... of XXX renewing the approval of the active substance glyphosate in accordance
More information2010 Annual Programme Twinning Fiche KS 10 IB AG 02 Veterinary and Food Safety
1. Basic information 2010 Annual Programme Twinning Fiche KS 10 IB AG 02 Veterinary and Food Safety 1.1 CRIS Number: 2010/022-452 1.2 Title: Veterinary and food safety 1.3 ELARG Statistical code: 03.12
More informationChinese Chemicals Regulation and the influence from EU REACH
Chinese Chemicals Regulation and the influence from EU REACH Jim Wei Hangzhou RUIO Technology Co., Ltd Tyre Industry Regulatory Dialogue Brussels, October 26, 2010 Hangzhou RUIO Technology Co., Ltd www.reach24h.cn
More informationThis document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
2012R0528 EN 25.04.2014 002.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B REGULATION (EU) No 528/2012 OF THE EUROPEAN PARLIAMENT
More informationResidues of Pesticides in foodstuffs of animal origin : Monitoring programs in France. Jean-Pierre ORAND French Ministry of Agriculture
Residues of Pesticides in foodstuffs of animal origin : Monitoring programs in France Jean-Pierre ORAND French Ministry of Agriculture AGENDA Legal framework Characteristics of the residue monitoring French
More informationStandard on ASEAN Good Aquaculture Practices for Shrimp Farming (ASEAN Shrimp GAP)
Appendix 11 Standard on ASEAN Good Aquaculture Practices for Shrimp Farming (ASEAN Shrimp GAP) 1. INTRODUCTION 1.1 Purpose and scope of ASEAN Shrimp GAP The ASEAN Economic Community Blue print (Section
More informationREACH regulation implementation
Actions to be taken by the National Governments and Chemical Industry Federations after the accession to the European Union Wojciech Lubiewa-Wielezynski Polish Chamber of Chemical Industry SEMINAR/TRAIN
More informationCurrent challenges from Evaluation point of view - Introduction case studies
Current challenges from Evaluation point of view - Introduction case studies Expert Workshop Dealing with Uncertainty of Non-Test Methods under REACH 23-24 September 2010 Wim De Coen ECHA Evaluation I
More informationPesticide Regulation System in Japan
Pesticide Regulation System in Japan Atsuko HORIBE 1 st Risk Assessment Division Food Safety Commission Secretariat Cabinet Office atsuko.horibe@cao.go.jp http://www.fsc.go.jp/english/index.html Contents
More informationINDO AFRICA PHARMA MEET 24-27TH SEPT, Hotel Marriot Hussain Sagar Lane, Road, Hyderabad India SPONSORED BY PHARMEXCIL
INDO AFRICA PHARMA MEET 24-27TH SEPT, 2009 Hotel Marriot Hussain Sagar Lane, Road, Hyderabad India SPONSORED BY PHARMEXCIL Drug Registration procedures in Tanzania Nditonda B. Chukilizo and Adonis Bitegeko
More informationCustoms Administration of the Republic of Macedonia
Customs Administration of the Republic of Macedonia Business & Customs World Customs Cooperation in Macedonia Forum 2010 Istanbul, October 2010 Vancho Kargov, DG vanco.kargov@customs.gov.mk Macedonian
More information12 th International Training Course Harmonisation of Fruit and Vegetables Quality Assessment
12 th International Training Course Harmonisation of Fruit and Vegetables Quality Assessment FOOD INSPECTION IN MAURITIUS with focus on fruit and vegetables Shalini A. NEELIAH Senior Research & Development
More informationDenmark's answers to questionnaire from special rapporteur on the right to food
Pesticides and Gene Technology Ref. VM/ANFJE 15. December 2016 Denmark's answers to questionnaire from special rapporteur on the right to food 1. National and international lows to regulate pesticides:
More informationREACH. Main concerns resulting from the implementation of REACH. Within the Aerospace Defence and Security business VERSION 1.5
REACH Main concerns resulting from the implementation of REACH Within the Aerospace Defence and Security business VERSION 1.5 This final document - version 1.5 issued on 16 May 2014 Cancels and replaces
More informationPublic Interest Incorporated Foundation BioSafety Research Center
Public Interest Incorporated Foundation BioSafety Research Center http://www.anpyo.or.jp Ver. 201801 Building #1(Test and research annex) Building #2 (Administrat ion office) Building #3 (Toxicity test
More informationThe Ten Commandments of the Sanitary and Phytosanitary Agreement of the World Trade Organization
Second FAO E-Conference on Veterinary Services 007_eng The Ten Commandments of the Sanitary and Phytosanitary Agreement of the World Trade Organization Héctor Campos Deputy Director, Agricultural Health
More information( ) Page: 1/10 NOTIFICATION
20 September 2016 (16-4994) Page: 1/10 Committee on Agriculture Original: Spanish NOTIFICATION The following submission, dated 12 September 2016, is being circulated at the request of the delegation of
More informationMyanmar Health Forum Myanmar International Convention Center II Naypyitaw, Myanmar (28-29 July 2015)
Myanmar Health Forum Myanmar International Convention Center II Naypyitaw, Myanmar (28-29 July 2015) Fostering Food Safety Infrastructure Development for Myanmar Food Industries MFPEA Presented by Dr.
More informationISPE Annual Meeting 29 October 1 November 2017 San Diego, CA
Ministry of Industry and Trade/ Department of pharmaceutical and medical industry development Moscow September 22, 2017 MEDICINES CIRCULATION SYSTEM IN THE RUSSIAN FEDERATION Ministry of Healthcare Medicines
More informationPrimary Distribution Activities
Primary Distribution Activities Wholesale Distribution Information Day, Paul Sexton GMP Manager Date Insert on Master Slide Slide 1 Topics What is a Primary Distributor / Wholesaler Special Responsibilities
More informationConsequences of REACH for the issuing of permits and licences under the provisions of the Dutch Environmental Management Act ( Wet milieubeheer - Wm
Consequences of REACH for the issuing of permits and licences under the provisions of the Dutch Environmental Management Act (Wet milieubeheer - Wm) and the Pollution of Surface Waters Act (Wet verontreiniging
More informationREGULATORY ACTIONS UNDER REACH & CLP FEEDBACK FROM ECHA S RAC
REGULATORY ACTIONS UNDER REACH & CLP FEEDBACK FROM ECHA S RAC Luxembourg, 8 December 2016 Annual Conference REACH&CLP Ruth MOELLER CONTENT ECHA and its Committees How substances of concern are regulated
More informationCIRCULAR REGULATIONS ON THE IMPORTATION OF USED MACHINERY, EQUIPMENT AND PRODUCTION LINE
MINISTRY OF SCIENCE AND TECHNOLOGY ------- SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom Happiness --------------- No.20/2014/TT-BKHCN Hanoi, July 15, 2014 3 RD DRAFT CIRCULAR REGULATIONS ON THE
More informationGUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES
MDEG - 2007-12 - II-3.3 MSOGClassIGuidance_Final GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES Foreword These guidance notes do not aim to be a definite interpretation of National Laws and/or
More informationCooperation in the field of toxicology, analytics, R&D and production
Cooperation in the field of toxicology, analytics, R&D and production Where you can find us 2 2 VUOS PARTNER FOR COOPERATION History 3 3 VUOS PARTNER FOR COOPERATION Organizational structure 1. R&D and
More informationInformation on the supply chain
Information on the supply chain Downstream user update 21 October 2015 Andrew Murray European Chemicals Agency Contents Vision on how information in the supply chain works. Tools that help with effective
More informationJustification Document for the Selection of a CoRAP Substance
Justification Document for the Selection of a CoRAP Substance Substance Name (public name): 1,1'-(isopropylidene)bis[3,5-dibromo- 4-(2,3-dibromopropoxy)benzene] EC Number: 244-617-5 CAS Number: 21850-44-2
More informationLegal and organisational conditions of applying Good Experimental Practice in the area of efficacy evaluation of plant protection products in Poland
State Plant Health and Seed Inspection Service Legal and organisational conditions of applying Good Experimental Practice in the area of efficacy evaluation of plant protection products in Poland Bogdan
More informationIMPORT HEALTH STANDARD FOR MILK AND MILK PRODUCTS FOR HUMAN CONSUMPTION FROM THE EUROPEAN UNION AND SWITZERLAND
IMPORT HEALTH STANDARD FOR MILK AND MILK PRODUCTS FOR HUMAN CONSUMPTION FROM THE EUROPEAN UNION AND SWITZERLAND Issued pursuant to Section 22 of the Biosecurity Act 1993 Dated: 19 July 2010 Important information
More informationREGULATIONS. L 44/2 Official Journal of the European Union
L 44/2 Official Journal of the European Union 18.2.2011 REGULATIONS COMMISSION REGULATION (EU) No 143/2011 of 17 February 2011 amending Annex XIV to 1907/2006 of the European Parliament and of the Council
More informationThe APIC Audit Programme Version 3, August 2010
The APIC Audit Programme Version 3, August 2010 Table of contents 1 General 2. APIC Audit Program 3 The Auditors 3.1 Educational Background and Experience 3.2 Auditor Training Courses for Certification
More informationEUROPEAN COMMISSION DIRECTORATE-GENERAL FOR AGRICULTURE AND RURAL DEVELOPMENT
EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR AGRICULTURE AND RURAL DEVELOPMENT Directorate B. Multilateral relations, quality policy The Director Brussels, JO/sn/agri.ddg.b.4(05)40549 Short report of the
More informationImpacto de las Nuevas Tendencias Regulatorias en la Producción de Parenterales. Innovacion en Packaging Primario
Impacto de las Nuevas Tendencias Regulatorias en la Producción de Parenterales Innovacion en Packaging Primario 1 Contents Company Highlight What s Changing in Pharma Pharma Trends Harmonisation New Requirements
More informationThis document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
2001L0018 EN 21.03.2008 003.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B DIRECTIVE 2001/18/EC OF THE EUROPEAN PARLIAMENT
More informationTBZ WG Page 1 of 26. REGISTRATION REPORT Part A. Risk Management
Page 1 of 26 REGISTRATION REPORT Part A Risk Management Product code: Product name(s): HORIZON ARBO - Active Substance(s): Tebuconazole WG 25 (250 g/kg) COUNTRY: FRANCE NATIONAL ASSESSMENT Application
More informationCommission Directive 2008/62/EC
Commission Directive 2008/62/EC of 20 June 2008 providing for certain derogations for acceptance of agricultural landraces and varieties which are naturally adapted to the local and regional conditions
More informationCOMMISSION OF THE EUROPEAN COMMUNITIES. Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 12.7.2006 COM(2006) 388 final 2006/0136 (COD) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL concerning the placing of plant protection
More informationREGISTRATION REPORT Part A. Risk Management. Product code: A16148C Product name(s): VIBRANCE Active Substance(s): Sedaxane, 500g/L
VIBRANCE (A16148C ) Page 1 of 26 Registration Report REGISTRATION REPORT Part A Risk Management Product code: A16148C Product name(s): VIBRANCE Active Substance(s): Sedaxane, 500g/L COUNTRY: FRANCE Zonal
More informationCOUNTRY PRESENTATION ON PLANT PROTECTION IN INDIA
COUNTRY PRESENTATION ON PLANT PROTECTION IN INDIA Workshop in Capacity Building for Information Exchange Kuala Lumpur, Malaysia (4-9 July 2011) Regional Workshop on use of APPPC website: 8-9 July 11 Plant
More informationMandatory inspection of sprayers in Europe, chances for the dealers! Jaco Kole SPISE Working Group
Mandatory inspection of sprayers in Europe, chances for the dealers! Jaco Kole SPISE Working Group Contents: What is SPISE Mandatory inspections of sprayers in Europe Current situation in Europe Chances
More informationOECD RECOMMENDATION ON THE SAFETY OF NANOMATERIALS
OECD RECOMMENDATION ON THE SAFETY OF NANOMATERIALS Workshop for the Asia-Pacific Region on Nanotechnology and Manufactured Nanomaterials: Safety Issues 10-11 September 2015, Bangkok, Thailand OECD Australia
More informationKingdom of Cambodia National Religion King ANUKRET ON STANDARDS AND MANAGEMENT OF AGRICULTURAL MATERIALS. The Royal Government of Cambodia
Filename: 08 ANK-Pesticide.doc Kingdom of Cambodia National Religion King Royal Government of Cambodia No. 69/ANK/BK ANUKRET ON STANDARDS AND MANAGEMENT OF AGRICULTURAL MATERIALS The Royal Government of
More informationChapter I. General Provisions
FEDERAL LAW NO. 109-FZ OF JULY 19, 1997 ON THE SAFE HANDLING OF PESTICIDES AND AGROCHEMICALS (with the Amendments and Additions of January 10, 2003, June 29, 2004, October 16, 2006) Adopted by the State
More informationMEDICATED FEEDINGSTUFFS AND SPECIFIED FEED ADDITIVES REGULATION AND APPROVAL OF MANUFACTURERS
MEDICATED FEEDINGSTUFFS AND SPECIFIED FEED ADDITIVES REGULATION AND APPROVAL OF MANUFACTURERS JANIS MCDONALD Medicated Feedingstuffs and Specified Feed Additives Operations Manager VETERINARY MEDICINES
More informationOrdinance on the Placing on the Market and Handling of Biocidal Products
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force. Ordinance on the Placing on the Market and Handling of
More informationEudraVigilance Vet. and Pharmacovigilance of vet. Medicinal products in Serbia
EudraVigilance Vet. and Pharmacovigilance of vet. Medicinal products in Serbia Presented by: Vladimir Raketić, DVM, spec; Audit /QM group Ministry of Agriculture, Forestry and Water Managment, Veterinary
More informationEUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
Ref. Ares(2016)248934-18/01/2016 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Directorate F - Food and Veterinary Office DG(SANTE) 2015-7475 - MR FINAL REPORT OF AN AUDIT CARRIED
More informationRepublika e Kosovës Republika Kosovo-Republic of Kosovo Kuvendi - Skupština - Assembly
Republika e Kosovës Republika Kosovo-Republic of Kosovo Kuvendi - Skupština - Assembly Law No. 03/L-016 ON FOOD Assembly of Republic of Kosovo, In support of Article 65, point (1), of the Constitution
More informationCLASSIFICATION OF NON-TARIFF MEASURES FEBRUARY 2012 VERSION
CLASSIFICATION OF NON-TARIFF MEASURES FEBRUARY 2012 VERSION A SANITARY AND PHYTOSANITARY MEASURES Measures that are applied: to protect human or animal life from risks arising from additives, contaminants,
More informationCommission II. National report for Serbia
Comité européen de droit rural European Council for Rural Law Europäische Gesellschaft für Agrarrecht und das Recht des ländlichen Raums Congrès européen de droit rural 11 14 septembre 2013 Lucerne (Suisse)
More informationGuidelines for Organic Certification of Crop Production
Your One Stop for Organic Certification In the World Market of Organic Certified Food How to get yourself Organic Certified as per International Standards (NPOP, NOP & EU-834/2007) Guidelines for Organic
More informationHARMONISING ENVIRONMENTAL RISK ASSESSMENTS OF PESTICIDES
HARMONISING ENVIRONMENTAL RISK ASSESSMENTS OF PESTICIDES OECD DEVELOPMENT OF TEST GUIDELINES AND METHODOLOGIES EFSA Scientific Conference on ERA of pesticides Parma, 15-16 November 2016 OECD Secretariat
More informationHosting Inspections from foreign countries: PMDA (Japan) ANVISA (Brazil)
Hosting Inspections from foreign countries: PMDA (Japan) ANVISA (Brazil) Kathrin Abelein Vice President Quality, R-Pharm, JSC First Russian GMP Conference 20. 22. September 2016 Agenda General information
More information