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The Spanish Agency of Medicines and Medical Devices (AEMPS) has introduced a streamlined procedure for submitting multiple modifications in a single marketing authorization application for medicines.

Key Points:

  • Applies to medicines from the same marketing authorization holder authorized through national procedures.
  • Eliminates the previous confirmation procedure for supergroup applications.
  • Laboratories must meet supergroup variation criteria and submit proposals for evaluation by AEMPS.

Source: https://www.aemps.gob.es/informa/la-aemps-habilita-un-nuevo-procedimiento-para-presentar-supergrupos-de-variaciones-de-medicamentos-autorizados-por-procedimiento-nacional/

Region: Spain

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