PLANT PROTECTION DIRECTORATE. Department for Plant Protection (PPP`s) and Plant Nutrition Products (PNP`s) MUTUAL RECOGNITION

Similar documents
Progress Report on the Implementation of PPPs Regulations in Republic of Croatia CEUREG FORUM XVIII MEETING

Guidance on the application of mutual recognition in Norway

Veterinary Medicines Legislation and Maximum Residue Limits in the EU

(Acts whose publication is obligatory) DIRECTIVE 98/8/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL. of 16 February 1998

Sarajevo April Regional Workshop on Implementation of Phytosanitary Standards in Forestry PLANT PROTECTION DIRECTORATE

Implementation of toxicological data from other legal provisions (e.g. REACH) An industry perspective

Austria: Experiences with the Zonal evaluation procedure Applying Regulation (EC) No.1107/2009

Import tolerances in the European Union Can Import Tolerances be set for active substances impacted by the EU hazard-based criteria?

Risk assessment: the bees (including a personal point of view from a private beekeeper)

Explanatory note on general fees payable to the European Medicines Agency

The rules governing medicinal products in the European Union. Presentation and content of the dossier Edition

GUIDANCE DOCUMENT ON WORK-SHARING IN THE NORTHERN ZONE IN THE AUTHORISA- TION OF PLANT PROTECTION PRODUCTS

COUNCIL DIRECTIVE of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC) (OJ L 230, , p.

RADIATION PROTECTION

Food and Agricultural Import Regulations and Standards - Narrative

Republic of Serbia Negotiating Group on Transport BILATERAL SCREENING MEETING. Chapter 14: Transport Policy Dangerous goods

12 Food safety, veterinary and phytosanitary policy. Questionnaire

Seminar on «EU Plant Health

ACVM - REGISTRATION STANDARD FOR TOXICOLOGY AND ENVIRONMENTAL TOXICOLOGY

DISCOVER OUR SEGMENT REGULATORY SCIENCE

Current activities of the European Commission in the area of pesticide residues

A Global CRO STRONGER TOGETHER

VETERINARY AND PHYTOSANITARY MATTERS

Justification Document for the Selection of a CoRAP Substance - Update -

(EFSA-Q ) 1 For the purpose of this document foods of animal origin are limited to fresh unprocessed products of animal origin.

Technical Notes for Guidance on. Dossier Preparation including preparation and evaluation of study summaries

Regulatory framework for seed treatments in the EU

Work plan for the GMP/GDP Inspectors Working Group for 2017

REACH REGULATION: the new management of chemicals in Europe and operational tools. R egistration. E valuation. A Ch. uthorisation.

CIRCULAR GUIDING ON THE FOOD HYGIENE AND SAFETY CONTROL FOR IMPORTED FOODSTUFFS OF ANIMAL ORIGIN

Bilateral screening: Chapter 27 PRESENTATION OF THE REPUBLIC OF SERBIA DIRECTIVE 2000/53/EC on end-of life vehicles

Organisation de Coopération et de Développement Économiques Organisation for Economic Co-operation and Development

10041/16 ADD 1 GSC/lt 1 DG B 2B

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY. EudraLex. Volume 4

ENFORCEMENT 9/16. Annual Report on control measures according to Article 68 of Regulation (EC) No. 1107/2009. kemikalieinspektionen.se.

mechanism. GMP certificates Belén Escribano, PhD Head of the Pharmaceutical Inspection and Enforcement Department of AEMPS

Polgar ACRO Registration of Pesticides in Russia and Ukraine: Applicants feedback

- A6/18 - Format for the listing of test and study reports and other documentation PART 4

Single market, implementation and legislation for consumer goods Pharmaceuticals : regulatory framework and market authorisations.

LAW ON PLANT PROTECTION PRODUCTS I BASIC PROVISIONS. Article 1

ECHA 1(7) Helsinki, 19 May 2014

Impact of the transposition of the European Clinical Trials Directive. CEMO, Paris 17 November 2004

The Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) Background and Coverage

Authorisation procedure for plant protection products. Description of the procedure for applications for zonal authorisations in Germany

LAW OF GEORGIA ON PESTICIDES AND AGROCHEMICALS (Last amended as of may 7, 2003, #2182)

Di Renzo Regulatory Affairs ROME - MILAN - LONDON

Information, test or study provided Y/P/N #

COMMISSION IMPLEMENTING REGULATION (EU) /... of XXX

2010 Annual Programme Twinning Fiche KS 10 IB AG 02 Veterinary and Food Safety

Chinese Chemicals Regulation and the influence from EU REACH

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

Residues of Pesticides in foodstuffs of animal origin : Monitoring programs in France. Jean-Pierre ORAND French Ministry of Agriculture

Standard on ASEAN Good Aquaculture Practices for Shrimp Farming (ASEAN Shrimp GAP)

REACH regulation implementation

Current challenges from Evaluation point of view - Introduction case studies

Pesticide Regulation System in Japan

INDO AFRICA PHARMA MEET 24-27TH SEPT, Hotel Marriot Hussain Sagar Lane, Road, Hyderabad India SPONSORED BY PHARMEXCIL

Customs Administration of the Republic of Macedonia

12 th International Training Course Harmonisation of Fruit and Vegetables Quality Assessment

Denmark's answers to questionnaire from special rapporteur on the right to food

REACH. Main concerns resulting from the implementation of REACH. Within the Aerospace Defence and Security business VERSION 1.5

Public Interest Incorporated Foundation BioSafety Research Center

The Ten Commandments of the Sanitary and Phytosanitary Agreement of the World Trade Organization

( ) Page: 1/10 NOTIFICATION

Myanmar Health Forum Myanmar International Convention Center II Naypyitaw, Myanmar (28-29 July 2015)

ISPE Annual Meeting 29 October 1 November 2017 San Diego, CA

Primary Distribution Activities

Consequences of REACH for the issuing of permits and licences under the provisions of the Dutch Environmental Management Act ( Wet milieubeheer - Wm

REGULATORY ACTIONS UNDER REACH & CLP FEEDBACK FROM ECHA S RAC

CIRCULAR REGULATIONS ON THE IMPORTATION OF USED MACHINERY, EQUIPMENT AND PRODUCTION LINE

GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES

Cooperation in the field of toxicology, analytics, R&D and production

Information on the supply chain

Justification Document for the Selection of a CoRAP Substance

Legal and organisational conditions of applying Good Experimental Practice in the area of efficacy evaluation of plant protection products in Poland

IMPORT HEALTH STANDARD FOR MILK AND MILK PRODUCTS FOR HUMAN CONSUMPTION FROM THE EUROPEAN UNION AND SWITZERLAND

REGULATIONS. L 44/2 Official Journal of the European Union

The APIC Audit Programme Version 3, August 2010

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR AGRICULTURE AND RURAL DEVELOPMENT

Impacto de las Nuevas Tendencias Regulatorias en la Producción de Parenterales. Innovacion en Packaging Primario

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

TBZ WG Page 1 of 26. REGISTRATION REPORT Part A. Risk Management

Commission Directive 2008/62/EC

COMMISSION OF THE EUROPEAN COMMUNITIES. Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

REGISTRATION REPORT Part A. Risk Management. Product code: A16148C Product name(s): VIBRANCE Active Substance(s): Sedaxane, 500g/L

COUNTRY PRESENTATION ON PLANT PROTECTION IN INDIA

Mandatory inspection of sprayers in Europe, chances for the dealers! Jaco Kole SPISE Working Group

OECD RECOMMENDATION ON THE SAFETY OF NANOMATERIALS

Kingdom of Cambodia National Religion King ANUKRET ON STANDARDS AND MANAGEMENT OF AGRICULTURAL MATERIALS. The Royal Government of Cambodia

Chapter I. General Provisions

MEDICATED FEEDINGSTUFFS AND SPECIFIED FEED ADDITIVES REGULATION AND APPROVAL OF MANUFACTURERS

Ordinance on the Placing on the Market and Handling of Biocidal Products

EudraVigilance Vet. and Pharmacovigilance of vet. Medicinal products in Serbia

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Republika e Kosovës Republika Kosovo-Republic of Kosovo Kuvendi - Skupština - Assembly

CLASSIFICATION OF NON-TARIFF MEASURES FEBRUARY 2012 VERSION

Commission II. National report for Serbia

Guidelines for Organic Certification of Crop Production

HARMONISING ENVIRONMENTAL RISK ASSESSMENTS OF PESTICIDES

Hosting Inspections from foreign countries: PMDA (Japan) ANVISA (Brazil)

Transcription:

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, 11 070 Novi Beograd e-mail: upravabilje@minpolj.gov.sr

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

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

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

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

OLD SYSTEM Article 31 34 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

Organizational Scheme of the PPD (valid since 06.2006. till 09.2008.) 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)

Organizational Scheme of the PPD (valid since 09.2008.) 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)

Contact SNEZANA SAVCIC-PETRIC Head of the Plant Protection and Plant Nutrition Products snezana.savcicpetric@minpolj.gov.rs www. minpolj.gov.rs

THANK YOU FOR ATTENTION