EU: EMA releases new / updated PIM guidance documents

New and updated Product Information Management (PIM) guidance documents have been released by the EMA recently:

The previously released version 1.3 of the PIM Concept Document has been updated to version 2.0. This comprehensive document gives a general overview about the concepts behind PIM and the general strategy and should usually be consulted first when starting with PIM. Changes to version 1.3 are numerous and mainly reflect the necessesity of consistency to the Data Exchange Standard (DES) 2.7.

Due to the same reasons the PIM Guidance for Applicants has also been updated to version 2.0.

In addition a new PIM Migration Guidance has been released in version 1.0 giving detailed guidance how to migrate product information text for human pharmaceutical products to PIM. It is recommended to consult the PIM Concept Document first.

[Source: EMA/PIM website]

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