Marketing Authorization Holders

Needless to say, pharmaceutical companies in the Netherlands must comply with international legislation relating to pharmacovigilance. Reports that meet the Council for International Organizations of Medical Sciences (CIOMS) criteria must be made to the Medicines Evaluation Board within 15 days and will also be included in the Lareb Foundation's database. In addition, Marketing Authorization Holders are required to submit periodic safety update reports, to include all information known to them concerning the safety of the preparations for which they hold marketing authorization. The Netherlands does not have a tradition of reports being made directly to the pharmaceutical industry by doctors or pharmacists; the vast majority of reports concerning suspected adverse drug reactions pass through the Lareb Foundation.

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