EU: EMA releases updates regarding PIM

The EMA has released a minor update of the PIM (Product Information Management) standards and data validaton rules. The update includes:

• New version 2.7.1 of the Data Exchange Standard (DES). See overview of the available DES documentation here
• New version 2.7.1 of the corresponding PIM Data Validation Rules
• Work Plan for DES version 2.8 for public consultation (provide comments by sending an email with the subject "DES 2.8 Public Consultation" to pim@ema.europa.eu by 23^rd April 2010)

The previously planned patch for DES 2.6 (DES 2.6.2) has been cancelled. For Q2/2010 and Q3/2010, DES 2.7 is the recommended version, whereas versions 2.6 and 2.6.1 will still be supported. Earlier versions will no longer be supported.

The update released today concerns (among other points):

• Rebranding of the European Medicines Agency (EMA)
• Alignement to the revised QRD Templates v7.3.1 in Dutch (NL) and French (FR)
• Alignement to the updated QRD Templates v7.3 to support the new SmPC Guideline and Advanced Therapy products (SmPC, Annex II, Labelling, and Package Leaflet)
• Increased flexibility on SmPC elements
• Increased flexibility on sequence of elements for SmPC, Labelling, and Package Leaflet
• Increased flexibility for standard statements, "substance" element and usage of emtpy lines
• Changes in the Life Cycle Management
• Changes to the comment function (granularity, layout for "reason")
• Structural and layout changes including support of "virtual documents" as a new way to generate documents
• Addition of procedure type "reformat" to support formal changes without changing content
• Addition of the “description” element to the “application” in the envelope

For a detailed overview on the changes, see the corresponding Release Notes for PIM DES 2.7.1

[Source: EMA PIM website]

Related News:

 EU: Updates for PIM released by EMA - 26.02.2010 23:07

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