Regulating decentralised manufacturing in the UK – a legal perspective
European Pharmaceutical Review
APRIL 14, 2025
In the EU, the EU pharmaceutical package of reform 5 includes a proposed new Directive, 6 which will replace the current Medicines Directive (2001/83/EC). Master file the manufacturing dossier in which the main regulatory documents are collected and to which all subordinate sites refer. For example, clinicians and hospitals.
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