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As the PIM Review System (PRS) is coming out of the pilot phase into production, The Agency would like to provide support for simulating PIM Submissions to Marketing Authorisation Holders (MAHs) and vendors.
The PIM Test simulation aims to help potential Applicants or Marketing Authorisation Holders and Vendors with no formal experience is using any PIM tool (LAT, PDVE, DES) to test the full life cycle of PIM submissions in the PRS i.e. the exchange of PIM files with comments. (Pre or Post Authorisation phases), technically validating the PIM files.
PIM test simulations are performed by prior notification and agreement between the Agency and applicants, or vendors.
It is requested that applicants and vendors submit a request in the form of a template, available here at least 3 weeks before a PIM test simulation start date.
A maximum of 3 PIM test simulations will be performed every calendar month.
All PIM Test simulation requests should be submitted to the PIM Helpdesk pim@ema.europa.eu.
Details of the PIM test simulation can be found in the guidance document.
Response to the feedback received is now available here
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