EMA Centralised Marketing Authorisation Procedure – One Licence for the EU Single Market

This hub connects SG Systems Global glossary entries and concepts relevant to the EMA centralised marketing authorisation (MA) procedure: eligibility, CTD dossiers, CHMP assessment, GMP and GxP expectations, QP release, pharmacovigilance and post-authorisation lifecycle control.

Updated December 2025 • EMA centralised marketing authorisation, EU MA procedure, CHMP opinion, CTD dossier, QP certification, GMP and GDP expectations, lifecycle variations and pharmacovigilance • Regulatory affairs, QA, QP, PV and manufacturing leaders in EU-facing organisations

The EMA centralised marketing authorisation procedure is the EU pathway that grants a single marketing authorisation, valid across the European Union (and associated countries), for qualifying medicinal products. For manufacturers and MA holders, it is as much an operating model as a regulatory route: one dossier, one benefit–risk decision, and one set of ongoing obligations that must be underpinned by a robust quality management system (QMS).

“The centralised procedure does not simplify your obligations – it centralises them. You trade multiple national conversations for one very deep EU-wide conversation about quality, safety and efficacy.”

1) What Is the EMA Centralised Marketing Authorisation Procedure?

The centralised procedure is the EU route where the European Medicines Agency (EMA) coordinates a single scientific evaluation of a medicinal product, leading to a central marketing authorisation granted by the European Commission. Once granted, that MA is valid across all EU member states (and some EEA partners), with one core set of approved product information.

• One dossier: a single Common Technical Document (CTD) submitted to EMA.
• One assessment: led by the Committee for Medicinal Products for Human Use (CHMP), supported by rapporteur/co-rapporteur teams.
• One MA: a centralised marketing authorisation, with one MA number and one MA holder.
• One safety data set: coordinated pharmacovigilance and risk management at EU level.

For manufacturers, this means that process validation, process validation and PPQ, GMP inspections, stability data, serialization, and QP release are all being scrutinised against a single, EU-wide standard rather than multiple national interpretations.

2) Scope and Eligibility – Which Products Must Use the Centralised Route?

The centralised procedure is mandatory for certain product categories and optional for others. Regulatory teams typically map product portfolios against EU rules to decide which route is available or required.

• Mandatory scope: many biotechnological products, ATMPs, orphan medicines and certain new active substances in defined therapeutic areas must use the centralised route.
• Optional scope: other innovative products, or those bringing significant therapeutic/technical benefit, may be eligible on request.
• Out of scope: some established, locally-focused products may still use decentralised or mutual-recognition procedures instead.

From an operations perspective, the important point is that once a product falls within the centralised scope, your entire manufacturing and quality system for that product is now operating under EMA/CHMP oversight, not just national agencies.

That has consequences for:

• Site selection and GMP inspection strategy.
• How you design your quality risk management (QRM) for EU supply.
• How early you lock in control strategies, specifications, and Quality by Design (QbD) elements.

3) Dossier and CTD Structure – What Needs to Be True on Paper

The centralised application uses the CTD (Common Technical Document) format, with quality, non-clinical and clinical modules that must tell a consistent story.
For manufacturing and QA leaders, Module 3 (Quality) and the associated GMP evidence are where most operational obligations are crystallised.

• Quality overall summary: how the control strategy, validation and specifications fit together.
• Drug substance / product sections: manufacturing descriptions, controls, in-process tests and stability data.
• Control strategy: linking specifications, IPCs, SPC, and PAT, where applicable.
• Validation packages: process validation, analytical method validation, cleaning validation, and hold-time data.

If your CTD promises a certain process capability, control limit or sampling plan, your shop-floor systems (MES, LIMS, QMS) must be able to prove that you actually operate that way.
EMA/CHMP expect your batch documentation and product quality reviews (PQRs) to align tightly with the approved dossier.

A common failure mode is allowing local “efficiency tweaks” that drift away from the registered process.
Under the centralised procedure, that drift quickly becomes a data integrity and variation-management problem.

4) EMA, CHMP, Rapporteurs and the Role of the Marketing Authorisation Holder

The centralised procedure involves defined roles on both the regulator and industry side.
Understanding those roles helps align your internal governance model.

• EMA: coordinates the scientific evaluation, timetables, and interactions.
• CHMP: the scientific committee that issues an opinion on the benefit–risk balance.
• Rapporteur / co-rapporteur: member states’ agencies that lead the evaluation for CHMP.
• Marketing authorisation holder (MAH): the legal entity responsible for the product once authorised.
• Qualified Person (QP): certifies each batch before release to the EU market.

For the MAH, this translates into:

• A robust QMS that spans development, manufacturing, distribution and pharmacovigilance.
• Clear delegation and oversight arrangements with contract manufacturers and suppliers.
• QP access to all data needed to certify batches against the approved MA and GMP requirements.
• Systems to detect, escalate and manage deviations, OOS and OOT events across sites.

EMA expects MAHs to demonstrate real control over outsourced activities, not just contracts on file.
That includes data flows, audit trails and technical agreements that explicitly support EU regulatory commitments.

5) Assessment Timelines, Questions and Clock-Stops – Surviving the Review

The centralised procedure has formal timelines, but the real experience depends on the quality of your dossier and how quickly you can respond to questions.
Operational teams often underestimate how much manufacturing and quality detail ends up in CHMP lists of questions.

• Initial validation: EMA checks completeness and accepts the dossier for assessment.
• Assessment phases: two main phases with intermediate assessment reports and consolidated questions.
• Clock-stops: the timetable stops while the MAH prepares responses, additional data or clarification.
• Opinion and decision: CHMP adopts an opinion; the European Commission issues the MA decision.

Typical quality/manufacturing themes in questions:

• Process robustness and validation design.
• Impurity control, degradation pathways and analytical specificity.
• Stability data, extrapolation and shelf-life justification.
• Control of critical raw materials and supplier qualification.
• Alignment between described processes and real-world manufacturing practice.

It is far easier to survive centralised review if production, QC and QA are involved early in dossier design and can quickly generate additional data from well-configured MES, LIMS and QMS systems when questions arise.

6) GMP, Inspections and QP Certification Under a Centralised MA

A centralised MA does not replace good manufacturing practice (GMP); it assumes it.
EMA and national inspectorates expect manufacturing and testing sites to operate under fully implemented GMP and QMS, with appropriate inspection history.

• GMP / cGMP – baseline standard for manufacturing and quality control.
• QMS – the framework that links SOPs, training, deviations, CAPA and management review.
• QP Release – batch certification against the MA and GMP.
• Environmental Monitoring and Temperature Mapping for facilities and storage.
• Asset Calibration Status (map to your calibration entry) and maintenance programmes.

The QP sits at the intersection of dossier and reality:

• They must have access to batch documentation and batch record lifecycle data to verify compliance.
• They rely on validated computer systems for data integrity and decision-making.
• They are accountable for ensuring that changes are appropriately handled via change control and variations, not informal tweaks.

Under a centralised MA, GMP inspection findings at one site can have EU-wide consequences for supply and credibility, making real-time visibility over deviations, CAPAs and trends particularly important.

7) Pharmacovigilance, Risk Management Plans and Safety Commitments

The centralised MA comes with EU-level pharmacovigilance (PV) and risk management obligations.
While PV is often led by specialised teams, manufacturing and quality still play a critical role in implementing and responding to safety signals.

• Risk Management Plan (RMP): describes identified and potential risks, and required risk minimisation measures.
• PV system master file: overarching description of the pharmacovigilance system in place.
• Signal detection and evaluation: may lead to changes in SmPC, labelling, or manufacturing controls.
• Product quality complaints: must be integrated with PV and CAPA processes.

For manufacturing sites, this means:

• Complaints and adverse event data must flow back into PQRs and continuous improvement.
• Risk minimisation measures (e.g. pack changes, warnings, additional testing) must be translated into concrete MES/WMS/QMS changes.
• Serious quality defects may trigger recalls coordinated at EU level, requiring solid recall readiness and traceability.

The key principle: safety insights from the field must be capable of changing how you manufacture, test, release and label the product – in a controlled, traceable manner.

8) Post-Authorisation Lifecycle – Variations, Renewals and Ongoing Evidence

An EMA centralised MA is not static.
As processes, suppliers, sites, specifications and clinical knowledge evolve, you are expected to manage these changes through a structured post-authorisation lifecycle.

• Variations: type IA/IB/II changes to the MA (e.g. new site, process change, specification tightening).
• Line extensions: new strengths, pharmaceutical forms or routes.
• Periodic safety and benefit–risk updates: periodic benefit–risk evaluation reports (PBRER/PSURs) and RMP updates.
• Renewals: re-assessment of the benefit–risk balance at defined intervals.

Internally, this demands:

• A clear link between change control and regulatory variation management.
• Use of PQRs/APRs to drive data-based changes.
• Alignment between real-world control strategies (in MES/LIMS) and the “registered” control strategy in the MA.
• Visibility over global supply chains, including serialization and packaging configurations.

EMA expects MAHs to proactively update and refine their dossiers rather than treating the MA as frozen while operations move on.
That means your regulatory and operational teams must work from a single source of truth for process and product knowledge.

9) How to Use This EMA Centralised MA Cluster

If you are preparing for, or already operating under, the EMA centralised marketing authorisation procedure, this glossary cluster can anchor a practical gap analysis and improvement roadmap.

• Clarify the route: confirm which products fall under the centralised scope and map their lifecycle obligations.
• Align dossier and reality: compare CTD commitments with actual process performance, deviations and PQR data.
• Check QMS coverage: ensure your QMS explicitly supports centralised MA obligations – GMP, GDP, PV and data integrity.
• Strengthen data flows: verify that MES, LIMS, QMS and ERP feed the data you need for QP release, inspections and variations.
• Make inspections predictable: use internal audits, mock inspections and QRM to surface issues before EMA or national inspectors do.
• Embed lifecycle thinking: link change control, CAPA, PQR, PV and regulatory variations so that improvements are systematically captured and implemented.

The goal is not simply “getting a centralised MA”, but running an inspection-ready, data-driven operation that can defend benefit–risk and product quality over the long term in every EU market where you choose to supply.

Related Reading (Glossary)
• Regulatory & QMS Backbone: GMP / cGMP | GxP | Quality Management System (QMS) | Qualified Person (QP) Release | Quality by Design (QbD)

• Manufacturing & Data Integrity: MES | LIMS | Data Integrity | Audit Trail (GxP) | Computer System Validation (CSV)

• Lifecycle & Continuous Improvement: Deviation / Nonconformance | CAPA | Product Quality Review (PQR) | Annual Product Review (APR) | Risk Management (QRM) | Recall Readiness