Why can’t PIM be used to support Mutual Recognition, Decentralised or National Products at present?
. The PIM standard depends upon having an agreed definition of the content and layout of the product information documents. In support of the Centralised Procedure it has been possible to define the standard based upon the QRD templates. In November 2005 CMD(h) adopted the ‘Annotated QRD Template for MR/DC Procedures’ as the basis for the Mutual Recognition and Decentralised Procedures. Work is currently progressing to analyse the areas of communality and additional national requirements for the presentation of the product information, with the objective of developing an appropriate DES and system to support MRP/DCP by 2008/2009. For National Procedures where national standards apply, most notably for the Package Leaflets, standards will need to be defined before PIM is adopted. There are no firm plans at present for the adoption of PIM for National Procedures.Q.3 An applicant is of the opinion that the PIM Specification does not adequately describe how to create a submission or there
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