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NEN EN ISO 27953-2 : 2011
Current
The latest, up-to-date edition.
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HEALTH INFORMATICS - INDIVIDUAL CASE SAFETY REPORTS (ICSRS) IN PHARMACOVIGILANCE - PART 2: HUMAN PHARMACEUTICAL REPORTING REQUIREMENTS FOR ICSR
12-01-2013
Defines a structure where reports can be exchanged in a clear and unambiguous manner such that the nature of the case, the circumstances in which it arose, and particularly the identity of the medicinal product(s) in question, can be communicated with certainty.
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