quality management

The quality management system of the Medicines Evaluation Board (MEB) is again this year certified on the basis of the ISO 9001-2008 standard.

The MEB was the first European authorisation agency to have its quality management certified.

Case Control Study 2013

The verification audit demonstratedĀ  that the MEB has a mature quality management system: all aspects of the system are satisfactorily closed in the Deming circle. However, the MEB has more ambitions: the MEB's ability to be self-critical is a characteristic which gives shape to the essential precondition for achieving continuous improvement. This observation is at the root of the numerous positive points identified during the audit. The two comments made in the previous audit have now been resolved. One new comment has been made (for details see the Findings section in the report).

Pharmacovigilance audits

According to article 101 (2) of the Directive 2001/83/ECĀ  it is mandatory for Member StatesĀ  to perform regular audits of their Pharmacovigilance system and to report the results to the European Commission. The report has been published:

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