Bernoth E M
Institute for Veterinary Medicine Berlin, Fed. Rep. Germany.
Zentralbl Veterinarmed B. 1990 Aug;37(6):401-6. doi: 10.1111/j.1439-0450.1990.tb01075.x.
The main purpose of the German drug law (August 24, 1976) is to guarantee quality, efficacy and safety of drugs for use in man and animals. The present particular situation for fish is as follows: 1. Several drugs (including antibiotics and antiparasitics) have been authorised before 1978. An application for prolonged authorisation has to be made before the end of 1989. For decisions on these applications, the Federal Health Office requires further scientific data of the active ingredients as a basis. 2. Certain chemicals (including malachite green) are subject to a simplified standard procedure for authorisation. Requirements concerning quality, restrictions of use etc. are published in monographs. 3. New drugs will be authorised according to the present national drug law until the establishment of EEC regulations. 4. Future decisions under EEC legislation shall consider potential risks for the environment (proposals to be included in the EEC directive 81/852) and more data specific for fish.
德国药品法（1976年8月24日）的主要目的是确保供人和动物使用的药品的质量、疗效和安全性。目前鱼类用药的具体情况如下：1. 1978年之前已批准了几种药物（包括抗生素和抗寄生虫药）。必须在1989年底前提交延长授权的申请。为了对这些申请做出决定，联邦卫生局需要更多活性成分的科学数据作为依据。2. 某些化学品（包括孔雀石绿）需遵循简化的标准授权程序。有关质量、使用限制等的要求在专论中公布。3. 在欧共体法规制定之前，新药将根据现行国家药品法进行授权。4. 未来根据欧共体立法做出的决定应考虑对环境的潜在风险（提案将纳入欧共体指令81/852）以及更多针对鱼类的特定数据。
