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Glossary
Marketing Authorisation Holder
A
Marketing Authorisation
Holder (MAH) is a company, firm or non-profit organisation that has been granted a
marketing authorisation
. The
marketing authorisation
allows the holder to market a specific medicinal product, in one or more EU member states. Once a medicinal product is marketed and in use by patients, the MAH continues to be responsible for monitoring
safety
(
pharmacovigilance
). Any suspected adverse reactions must be reported to the body which granted the
marketing authorisation
, in the form of a
periodic safety update report
(PSUR).
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