24 March 2006
EMEA:
PAT Presentation of information in Marketing
Authorisation dossiers
The EMEA PAT team has published a reflection paper providing preliminary
recommendations on how PAT related information should be presented in
applications or variations to Marketing Authorisations. Work on this
topic is under continuing development and as a flexible regulatory
approach is important to avoid unnecessary barriers to improved product
quality, it is not appropriate to publish formal guidance at this time.
Nevertheless, the paper is intended to assist companies planning to file
PAT-based submissions in the short to medium term. Feedback from the
industry on the contents of the paper is welcome and should be sent to
David.Cockburn@emea.europa.eu
View the PAT reflection paper.
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