Which post-marketing database and studies does EMEA require

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Which post-marketing database and studies does EMEA require.

The European process for assessment of pharmaceutical products is complex and presents with diVerent levels. There is the European level with two major procedures resulting in decisions on approval after applications to market a pharmaceutical product in European countries. One is the centralised procedure organised by the European Medicines Evaluation Agency (EMEA). The other one is the mutual...

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ژورنال

عنوان ژورنال: Annals of the Rheumatic Diseases

سال: 2000

ISSN: 0003-4967

DOI: 10.1136/ard.59.suppl_1.i36