The purpose of this law is to ensure, in the interest of a proper supply of the population with medicinal products, the safety in the traffic of medicinal products, especially regarding the quality, effectiveness, and safety of medicinal products, in accordance with the following regulations. The text consists of 149 articles divided into 18 Parts as follows: Purpose of the act, definition of terms, scope (I); Requirements on medicinal products (II); Manufacture of medicinal products (III); Approval of the medicinal products(IV); Registration of medicinal products (V); Protection of human subjects in clinical trials (VI); Dispensing of medicinal products (VII); Safety and quality control (VIII); Observation, collection and evaluation of drugs risks (X); Monitoring (XI); Special provisions for the federal armed forces, federal police, public order police and civil protection (XII); Import and export (XIII); Information officer, pharmaceutical consultant (XIV); Designation of the competent higher federal authorities and other provisions (XV); Liability for damage caused by medicinal products (XVI); Penal provisions and provisions on administrative fines (XVII); Transitional and interim provisions (XVIII). Chapter (IX) with regard to special provisions for medicinal products intended for use in animals is repealed and deleted.
Germany · 1976-08-24