SPOR Blog July 2017

By 10. July 2017Blog

EMA will invite industry stakeholders to begin registering their super users and start using the RMS and OMS from October 2017.

Until the registration begins (October) industry stakeholders can view and search public data as guest users. In case of RMS, guest users can view public lists and for OMS, all content can be viewed. The OMS dictionary (list of organizations with associated physical locations) currently only includes NCA organization data and the dictionary will gradually be expanded with new data. By the end of Q3 2017, EMA Data Stewards will have cleansed, standardized and published the following set of organization data:

  • Marketing Authorisation Holders (MAHs): Human (H) + Veterinary (V) Centrally Authorised Products (CAPs) and Human (H) Nationally Authorised Products (NAPs);
  • Marketing Authorisation Applicants (MAAs): (H+V) CAPs;
  • Maximum Residue Limit (MRL) applicants (Veterinary).

To access the SPOR portal, follow this link: http://spor.ema.europa.eu/sporwi/

The launch of RMS and OMS does not immediately change any regulatory submission processes. However, EMA is consulting stakeholders on the benefits of using the SPOR data for different regulatory procedures. More information will be provided via separate update.

Although IDMP timelines have changed, it is still important to understand both the RMS and OMS data sets and be prepared for their potential use in other areas such as the eAF and xEVMPD.

 

Author Jim Nichols

Jim is the vice president for Life Sciences in North America. He has nearly 20 years of experience with compliant software solutions for regulated processes. Jim has worked in senior management positions at Liquent, Thomson Reuters, ePharmaSolutions and DitaExchange. Jim has a Bachelor of Science degree in Mathematics from the Pennsylvania State University.

More posts by Jim Nichols

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