National Procedure, MAA Submissions, QPPV, EU, NP

Freyr helps in market authorization application (MAA) submissions by National Procedure (NP) & appointing Qualified Person (QP) for quality and QP for Pharmacovigilance (QPPV) in respective EU member states (concern member state [CMS] or reference member state [RMS])
If an applicant aims to procure a marketing authorization (MA) in a chosen European Union (EU) member state, it is required to submit market authorization application (MAA) to the respective state’s competent authority through National Procedure (NP).

The competent authority is responsible for reviewing and granting MA. Most of the Health Authorities (HAs) require 210 days for review and approval of MAA, however it may vary slightly from HA to HA of different member states followed by national phase for translation activities.

If an MA is granted by competent authority of EU member state and the applicant would like to register the medicinal product in any other EU member state, MA holder can file the same MAA to required state (which will be referred to as concern member state [CMS]) and the member state who authorized the MAA shall be considered as reference member state (RMS).
Know more at Freyr Page - National Procedure (NP)

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