First PIM submission received by the EMEA
The European Medicines Agency (EMEA) has received its first new marketing authorization application via the agency's product information management system, which only became operational on June 21.
The EMEA issued a statement to announce the first live PIM submission received, noting that this would be the only application handled via this technology until later this year. The agency explained that, "over the summer months, training will be provided to all member states in time for wider review of this first submission."
In the meantime, a series of internal and wider simulations is planned by the EMEA for every post-authorization submission type, to ensure the PIM review system is robust. The system should be fully operational by November. The software can be found at: http://pim-test.emea.eu.int/plat/.
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