Marketing authorisation of fish drugs--current status and future intentions.

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.