Int J Risk Saf Med. 1996;9(2):101-6. doi: 10.3233/JRS-1996-9207.
The International journal of risk & safety in medicine
A Bertelsmann
PMID: 23510848 DOI: 10.3233/JRS-1996-9207
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.