Authority News

24.03.06 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 http://www.emea.europa.eu/Inspections/docs/PATGuidance.pdf