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Glossary

Expedited Criteria

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Criteria that should be fulfilled for expedited reporting. The four minimum information required for expedited reporting are: an identifiable patient, the name of the suspect medicinal product, an identifiable reporting source, and an event or outcome that can be identified as serious and unexpected.  

Other glossary definitions

M

Micro-organism

Micro-organism means any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic…

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N

Name Patient Use

Supply of a medicinal product which is excluded by a Member State from the provisions…

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