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.

• The following regulated documents will no longer be required as PPI attachments:
  • Condition of marketing authorisation
  • Labelling
  • Package Leaflet

• Additionally, the following data will also no longer be required:
  • Intensive Monitoring
  • Location of the Pharmacovigilance System Master File
  • Description of Packaging Information

Outstanding deliverables:

• As a pre-requisite, the EVWeb data entry tool needs to be updated. As a consequence, EMA currently expects availability of EVWeb by mid April which would constitute a further major delay. The final date still needs to be confirmed by EMA.
• The Legal Notice and the Detailed Guidance documents need to be revised. It is currently not clear when they will be available. The same holds true for the still outstanding example files, controlled vocabularies and Q&A documents.
• The training program and material will be updated in addition. E-learning modules will be prepared
• EMA business processes will be revised

EMA is currently working hard on these deliverables to make them available as soon as possible.

Important note: the above-mentioned information has not yet been officially published by EMA. It represents the outcome of the EMA workshop with European Pharmaceutical Industry Associations on January 30, 2012. Final information can therefore deviate from the information above.

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