FDA
The new article addresses the aspects related to various matters associated with the licensing process for establishment licenses.
FDA
This article highlights the aspects related to the approach to be applied when determining whether a notification is required.
BfArM
The article addresses the aspects related to the fees payable by the interested parties and also provides definitions of the most important terms and concepts.
CHMP
The article highlights the key points associated with the regulatory framework for specific categories of medicinal products.
FDA
The article highlights the key points related to notification requirements medical device manufacturers should follow with respect to possible discontinuance or interruption in the manufacturing process.
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