Spanish Agency for Medicines and Health Products Expedites Drug National Code Application Process

December 22, 2022

The Spanish Agency for Medicines and Health Products (AEMPS) has implemented changes to the application process for national code (NC) of centrally authorized medicinal products. Applicants may now send their NC application once they and the relevant regulatory agencies finalized texts. This and other changes are intended to speed up the application process.

According to Montserrat Llopart and Javier Saladich, “In addition, the AEMPS has published a guide on its own website in which it has updated and compiled all the information on the documents required to assign an NC, as well as any future modifications that may be made. These changes are included in the “AEMPS’ Annual Work Plan 2022”, whose objectives include the optimization of its organizational management.”

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(Source: Global Compliance News, December 22nd, 2022)

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