01 February 2012

Exalon: EMA informs stakeholders about reduced data requirements for XEVMPD

The European Medicines Agency informed stakeholders from the pharmaceutical industry about the proposed way forward to progress with the implementation of Article 57(2) of Regulation (EC) 726/2004 as amended by Regulation (EC) 1235/2010.

One major fact that has been confirmed in this context by EMA is that the deadline of July 02, 2012 cannot be extended and therefore still applies. However, due to tremendous push-back from industry stakeholders and software vendors a more stepwise approach toward full ISO IDMP implementation will be followed.

As a first step the EMA announces a substantial reduction of the mandatory EVMPD data set for July 02, 2012:

    * The new scenario foresees that the provision of detailed data regarding substances used in medicinal product as currently specified in Chapter 4 - Structured Substance Information (SSI) will no longer be required but can be provided on an optional basis by applicants. In this context it has been emphasized that the information detailed in the current SSI will most likely be required at a later point in time, presumably in 2015 when the underlying ISO IDMP standards are going to be fully implemented. It has been noted that this could lead to duplicate efforts on the side of the industry in the longer term.

    * A further significant reduction in administrative burden constitutes the fact that for the Printed Product Information (PPI) only the SPC in English language needs to be provided. This holds true for Medicinal Products authorized through MRP/DCP or through the Centralized Procedure. For purely national authorized or registered products the SPC will be required in the corresponding local language. Please note that the current language requirements for certain data fiels (e.g. substance translations) still apply.

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