Legislation and Institutional/Administrative Capacities

1. Legislation and Institutional/Administrative Capacities - PLANT PROTECTION - Sub-Committee for Agriculture and Fishery European Commission - Republic of Macedonia Skopje, 15 April 2005

2. Stabilization and Association Agreement Article 68 –”The Parties recognise the importance of the approximation of the existing and future laws of the Republic of Macedonia to those of the Community. The Republic of Macedonia shall endeavour to ensure that its laws will be gradually made compatible with those of the Community” Article 100 -”Cooperation in this field shall have as its aim the modernisation and restructuring of agriculture and the agro-industrial sector, water management, rural development, the gradual harmonisation of veterinary and phytosanitary legislation with Community standards and the development of fishery and forestry sectors in the Republic of Macedonia”

3. Current National Legislation Law onPlant Protection (25/98) Amendments on the Law on Plant Protection (6/00) Law on Seed, Seedling and Propagating Material (41/00) Law on Marketing of Poisons (13/91) Law on Production of Poisons (18/76)

4. Secondary Legislation Lists ofquarantine and economic harmful plant diseases and pests Book of rules for plant health control during placing on the market across the state border Book of rules for the manner of declaration of plant protection products Book of rules for the requirements to be fulfilled by legal persons concerning the equipment, devices, premises for carrying out production, gross and retail marketing of PPPs, and the content and the manner of keeping the register Book of rules for the manner of issuing license for placing on the market of PPPs Order for quarantine supervision during import of seedling material of perennial plants Order for undertaking measures during import of potatoes in the Republic of Macedonia

5. Law on Plant Protection 25/98 In the area of plant protection the following is regulated: Responsibilities of the keepers Responsibilities of the competent authority Compulsory health check of seed field and facilities for perennial seedling material Health control of plants and plant products during export, import, re-export and transit Control over the implementation of the provision of this Law

6. Law on Plant Protection 25/98 In the area of plant protection products the following is regulated: Procedures for authorization of PPPs Registers for producers and placing on the market of PPPs Control over the production, placing on the market and use of PPPs

7. Harmonization of the Legislation Plant Health Law harmonized with the EU Council Directive 2000/29/EC Plant Protection Products Law harmonized with the EU Council Directive 91/414/EC Secondary Legislation

8. Harmonization of the Legislation The new Plant Health Law shall regulate: List of harmful organisms Establishing protected zones in the Republic of Macedonia Establishing register for producers, processors, importers and distributors Introducing plant passports Monitoring, prognosis and application of biological measures Collecting, use and data exchange Public services and public authorizations Establishing expert council Conducting phytosanitary control inland and at the border posts, and inspection supervision over the implementation and enforcement of the provisions of this Law Establishing of State Phytosanitary Laboratory (SPL) PPD as a central organ for coordination and implementation of the Law

9. Harmonization of the Legislation The objectives of the Plant Health Law are: To protect the plants and plant products from harmful organisms To prevent introduction and spreading of harmful organisms Timely identification and carrying out measures for suppression of harmful organisms Optimal production and increasing the international trading exchange of agricultural and forestry products, and - Harmonization of the National legislation with EU regulations and fulfilling the international standards

10. Harmonization of the Legislation The secondary legislation shall be enacted on the basis of the new Plant Health Law: List of harmful organisms, plants, plant products and other objects (Annex I-V) Protection zones Plant passports Registers of the manufacturers Orders for prohibition of import and setting the requirements

11. Harmonization of the legislation The New Plant Protection Products Law shall regulate: • Processing application • Dossier evaluation and assessment of active substance and product • Authorization of PPPs • Labeling and packaging • Control of the placing on the market and the use • Official examination • Setting of residues • Informing the relevant bodies and institutions

12. Harmonization of the legislation The objectives of the New Plant Protection Products Law : • Control over the placing on the market and use • Human and animal health protection • Protection of the environment, and • Harmonization of the National legislation with the EU regulations and fulfilling the international standards

13. Harmonization of the Legislation Secondary legislation which shall be enacted on the basis on the new Plant Protection Products Law: - List of active substances of the Directive 91/414 Annex I - National List of active substances - Annex II (Data requirements for active substances) - Annex III (Data requirements for products) - Annex IV (Book of rules for submission of applications, procedures for processing and authorization of plant protection products - Annex V (Standard phrases) - AnnexVI (Uniform Principles)

14. Institutional/Administrative Capacities Current Organizational Structure: Ministry of Agriculture, Forestry and Water Economy • Plant Protection Directorate • State Agricultural Inspectorate, and • State Inspectorate for Forestry and Fishery

15. Institutional/Administrative Capacities Competency of the Ministry of Agriculture, Forestry and Water Economy Plant Protection Directorate: • Plant protection • Plant and plant products heath check • Authorization of PPPs – Phase II • Keeping registers for production and placing on the market • Control over the implementation of the provisions of the Plant Protection Law and the secondary legislation based on it

16. Institutional/Administrative Capacities Ministry of Health: • State Health and Sanitary Inspection • Bureau for Medicines, and • Food Safety Directorate

17. Institutional/Administrative Capacities Competency of the Ministry of Health: • Procedure for authorization of PPPs – Phase I • Classification in group of poisons, and • Control of production and placing on the market of active substance and pesticides residues

18. Institutional/Administrative Capacities Current Organizational Structure: • Institutions and experts involved for plant health • Agricultural Institute-Skopje • Institute for Tobacco-Prilep • Institute for Agricultural and SouthernCrops-Strumica • Faculty for Agricultural Sciences and Food

19. Institutional/Administrative Capacities Current Organizational Structure: Institutions and experts involved in the plant protection products • Agricultural Institute-Skopje • Institute for Tobacco-Prilep • Institute for Agricultural and Southern Crops-Strumica • Faculty for Agricultural Sciences and Food • Institute for pre-clinical and clinical pharmacology with toxicology • Institute for Applied Biology The above mentioned institutions carrying out biological examinations, assessment of the dossier, products efficacy, determination of physico-chemical properties and toxicological and eco-toxicological properties

20. Institutional/Administrative Capacities Laboratory for identification of plant pests: • Agricultural Institute-Skopje • Institute for Tobacco-Prilep • Institute for Agricultural and Southern Crops-Strumica Laboratory for examination of PPPs: • For physico-chemical examination: • Agricultural Institute-Skopje • Faculty for Agricultural Sciences and Food 2. For setting residues: • Veterinary Institute • Republic’s Institute for Health Protection • Regional Institute for Health Protection

21. Institutional/Administrative Capacities Future Organizational Structure in compliance with the new Plant Health Law and Plant Protection Products Law : The competent authority is the Ministry of Agriculture, Forestry and Water Economy The Plant Protection Directorate The Plant Protection Directorate shall be consist of 4 departments: • Phytosanitary Inspection Department • Plant Protection Department • Agro-chemical Department • Phytosanitary Regulation and Management Department

22. Institutional/Administrative Capacities State Phytosanitary Laboratory (SPL) Phytopathology • Virology • Bacteriology • Nemathology • Entomology • Laboratory for Seeds Control • Chemical examinations for control of active substances and PPPs

23. Institutional/Administrative Capacities Competency of the Phytosanitary Directorate: • Phytosanitary Inspection • Plant protection • Authorization of the plant protection products • Phytosanitary regulation and management • Coordination and informing of all interestedparties, EU and international relevant institutions

24. Skopje Skopje Skopje Kumanovo Blace Tetovo Blato Bitola Cafasan Medzitlija Veles Kocani Kriva Palanka Bogorodica Gostivar Novo Selo Demir Hisar Delcevo Resen Deve Bair Negotino Sveti Nikole Tabanovce Debar Dojran Resen Sk. Aerodrom Kavadarci Oh. Aerod. Tetovo Kratovo Posta - Sk Kicevo Zeleznica: Sk, Tabano, Gevge Ohrid Strumica Gevgelija Probistip M. Brod Struga Srumica Bitola Stip Krusevo Radovis Gevgelija Vinica Prilep Berovo Kocani Delcevo Kavadarci Valandovo Future Organization MINISTRY OF AGRICULTURE, FORESYRY AND WATHER ECONOMY MINISTER Other Laboratories STATE PHYTOSANITARY LABARATORY DIRECTOR PHYTOSANITARY DIRECTORATE DIRECTOR Department of Phytosanitary Inspection Plant Health Department Agro-chemistry Department Phytosanitary Regulation and Management Regional Informer Inland Phytosanitary Inspectors Phytosanitary Inspector at the Border Post

25. Recommendations • Providing new projects • Education related to harmonization of the legislation • Further support on institutional straitening: human resources and equipment