Statutory regulations governing the reporting of adverse reactions

Issue title: 2nd International Symposium on Drug Safety

Article type: Research Article

Authors: Bertelsmann, Annekarin

Affiliations: Bundesinstitut für Arzneimittel und Medizinprodukte, Seestraße 10, D-13353 Berlin, Germany

Abstract: Under the Drug Law (AMG) of 1976, applicants for marketing authorisations were obliged to notify the competent authorities of any new information about the product. When the Second Amendment came into force on 17 February 1987, the regulation became tighter in so far as applicants were obliged to notify the competent authority once they get to know of any suspected adverse reaction or interaction with other agents that could be a health hazard, including frequent drug abuse or a considerable drug abuse in an individual case.

DOI: 10.3233/JRS-1996-9207

Journal: International Journal of Risk and Safety in Medicine, vol. 9, no. 2, pp. 101-106, 1996