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Nervenarzt. 1996 Dec;67(12):1040-5.

[Abrupt end of systematic evaluation of the non-prescription drug market relating to psychiatry, neurology and anesthesia].

[Article in German]

Author information

1
Psychiatrische Klinik und Poliklinik, Freie Universität Berlin.

Abstract

Between 1984 and 1994 the legally required task force "Advisory Committee to the German Federal Health Office in Matters of Approval and Review of Existing Medicines B3-Psychiatry, Neurology, Anesthesiology" analyzed and evaluated the CNS-active compounds that until then had only possessed a fictitious registration. The evaluation was related to efficacy and safety within the indications claimed by the producers. Reviews and monographies had to be established for 445 basic compounds. One hundred positive and 30 negative monographies were published. "Negative" indicates that none of the claimed indications could be accepted by the committee. It is regrettable that the Federal Health Agency did not notice a considerable part of these negative evaluations until the present date. The process of the "Aufbereitung" was stopped abruptly by the 5th amendment of the German Drug Law in August 1994,--a very doubtful political decision with respect to drug safety in this country.

PMID:
9082196
DOI:
10.1007/s001150050090
[Indexed for MEDLINE]

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