National Procedure (NP) Services – Overview
To obtain a Marketing Authorization (MA) in a specific European Union (EU) member state, applicants must submit a Marketing Authorization Application (MAA) to the respective competent authority via the National Procedure (NP)
The competent authority is responsible for reviewing and granting the MA. Most Health Authorities (HAs) require approximately 210 days to review and approve the MAA, followed by a national phase to complete translation and local requirements. Timelines may vary slightly depending on the member state.
If the MA is granted by the competent authority in one EU member state and the applicant wishes to register the same medicinal product in other EU member states, the original MA holder can submit the MAA to the other member states, which are then considered Concerned Member States (CMS), while the member state that originally authorized the product acts as the Reference Member State (RMS).
With expertise in handling Article 10(1) submissions, X Pharma Plus provides end-to-end support for MAA submissions under the National Procedure. Additionally, the company assists manufacturers in appointing a Qualified Person (QP) for quality and a Qualified Person for Pharmacovigilance (QPPV) in the respective member states to ensure compliance with quality standards and post-market surveillance requirements.
National Procedure (NP) – Services
“Used to obtain marketing authorization for a medicinal product in a single EU member state only.”