Phytopharmacy Law.

This Law regulates the rules for registration and authorization of phytopharmaceutical products (medicines with pure active substances that come from plants or parts of plants) in commercial form and sets all necessary provisions regarding their placement on the market, production, use and control on the territory of the Northern Republic Macedonia, including rules for approval of active substances, antidotes and synergists of which phytopharmaceuticals are composed or contained, the rules for additives and conformulants, as well as issues related to residues deriving from such phytopharmaceuticals products. This Law establishes a framework for achieving sustainable use of hytopharmaceutical products by reducing their risks and impacts of use on human, animal and environmental health and monitoring principles of integrated plant protection. This Law is further harmonized with the provisions of the Regulation (EC) No. 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC.
Main topics covered in this text are divided into nineteen thematic Chapters, and a total of 83 articles. Titles of Chapters are as follows: I. General provisions; II. Active substances, antidotes, synergists, co-formulas and basic substances; III. Phytopharmaceutical products; IV. Renewal, modification or supplement, cancellation and suspension of the approval decision; V. Special cases; VI. Data protection and public access to information; VII. Packaging, labelling and advertising of phytopharmaceuticals products and auxiliaries; VIII. Registration of economic operators; IX. Training; XII. Application equipment for phytopharmaceutical products; XIII. Emergency measures; XIV. Statistics for phytopharmaceutical products; XV. Import of phytopharmaceutical products; XVI. Supervision; XVII. Misdemeanor bodies (institutions); XVIII. Misdemeanor provisions; XIX. Transitional and final provisions.