Regulation of the Minister of Marine and Fisheries No. 1/PERMEN-KP/2019 on Fish Drugs.

This Government Regulation, consisting of 52 articles divided into seven Chapters and eight Appendices, regulates the Fish Drugs. The scope of this Ministerial Regulation includes: a) Supply and distribution of fish drugs; b) Service licensing, classification and certification; c) Reporting; and d) Supervision. Fish medicine is based on the intended use for: a) preventing and/or treating fish health; b) relieving symptoms of fish disease; and/or c) modifying the chemical processes in the fish body. The provision of Fish Medication whose active substance or one of its active substances is a genetically modified product (GMO) can be carried out after obtaining a biological safety certificate of genetic engineering products from the Biosafety Commission. Field testing as referred to in paragraph (1) includes an efficacy test and/or safety test, namely: a) types of biological preparations in the form of vaccines; b) types of pharmaceutical preparations in the form of antibiotics are equipped with a fish drug stop time test; and c) types of probiotic preparations.
The Regulation is divided as follows: General Requirements (Chap. I); Supply and Circulation of Fish Drugs (Chap. II); Certificate Service and Description (Chap. III); Reporting (Chap. IV); Supervision (Chap. V); Transitional Provisions (Chap. VI); Final Provisions (Chap. VII).