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Description of content: This
Regulation lays down Union procedures for the authorisation, supervision and
pharmacovigilance of medicinal products for human use at Union level,
establishes rules and procedures at Union and at Member State level relating
to the security of supply of medicinal products and lays down the governance
provisions of the European Medicines Agency established by Regulation (EC) No
726/2004 which shall carry out the tasks relating to medicinal products for
human use that are laid down in this Regulation, Regulation (EU) No 2019/6
and other relevant Union legal acts.
It revises and replaces Regulation (EC) 726/2004 (general),
Regulation (EC) 141/2000 (rare disease medicines) and Regulation (EC)
1901/2006 (paediatric medicines).
The Regulation contains both technical regulations and conformity
assessment procedures.
1. Technical regulations: The Regulation establishes certain
conditions for the marketing authorisation of medicinal products for human
use at central (EU) level. The Regulation also establishes rules at Union and
at Member State level relating to the security of supply of medicinal
products including the monitoring and management of shortages and critical
shortages.
2. Conformity assessment procedures: The Regulation establishes the
procedures for the authorisation of medicinal products for human use at
central (EU) level. It also establishes procedures at Union and at Member
State level relating to the security of supply of medicinal products
including the monitoring and management of shortages and critical shortages.
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