Centralised, National, Mutual Recognition and Decentralised Procedures Explained

Table of contents

• Introduction
• The four routes at a glance
• Centralised procedure
• Institutions and outcome
• Pharmacovigilance implications
• National procedure
• Mutual-recognition procedure
• When it is used
• Practical implications
• Decentralised procedure
• When it is used
• Practical implications
• Choosing a route and managing PV interfaces
• Disagreements and referrals
• Terminology that prevents confusion
• References
• Regulatory Note

Introduction

EU medicines can obtain marketing authorisation through a centralised procedure, a national procedure, a mutual-recognition procedure (MRP) or a decentralised procedure (DCP). These are different procedural routes, not different standards of scientific quality.

The correct route depends on the product, its legal basis, the intended territories, whether a national authorisation already exists and whether the product falls within the mandatory or optional scope of the centralised procedure.

The four routes at a glance

The procedure determines who coordinates the assessment and how the authorisation is granted. It does not remove the MAH’s pharmacovigilance obligations.

Centralised procedure

Institutions and outcome

The applicant submits to EMA. CHMP conducts the scientific assessment and adopts an opinion. The European Commission then adopts the Union decision. A centrally authorised product has a single EU marketing authorisation, with product information applying across the relevant Union framework.

The centralised route is mandatory for certain categories and may be available for others. Eligibility should be checked against current legislation and EMA guidance rather than inferred from product type alone.

Pharmacovigilance implications

The MAH operates one Union authorisation but still needs a functioning pharmacovigilance system, PSMF, QPPV, signal management, aggregate reporting, risk management and national implementation awareness. Central authorisation does not mean every safety activity is performed by EMA or that local healthcare-system information can be ignored.

National procedure

A national procedure results in an authorisation granted by one Member State’s competent authority. It may be appropriate where the product is intended for one territory or where the relevant legal route is national.

National authorisation does not create a lower pharmacovigilance burden. The MAH must meet EU and national requirements applicable to the product and maintain appropriate oversight of local safety information, literature, reporting and risk minimisation.

Mutual-recognition procedure

When it is used

MRP is used when a product already has a national marketing authorisation in one Member State and the applicant seeks recognition in one or more additional Member States. The first state is the Reference Member State (RMS); the requested states are Concerned Member States (CMS).

The RMS assessment and product information form the basis for recognition, subject to the applicable procedure and any issues raised by CMS.

Practical implications

The MRP extends an existing authorisation. It is not a second scientific assessment from first principles in every CMS, although CMS review and national implementation remain important. The MAH should maintain a controlled view of procedure numbers, product information versions, national texts, local reporting arrangements and post-authorisation commitments.

Decentralised procedure

When it is used

DCP is used when the product has not yet received a national authorisation in the participating Member States and the applicant seeks authorisation in several states at the same time. The applicant chooses an RMS and identifies CMS.

An identical application is submitted to the participating authorities. The RMS coordinates the assessment and CMS review the emerging assessment and product information. After a successful procedure, national marketing authorisations are granted by the participating Member States.

Practical implications

DCP produces harmonised national authorisations, not one Union authorisation. Local implementation, national names, pack information and safety communication may still require controlled coordination. Pharmacovigilance procedures should map these interfaces before launch.

Choosing a route and managing PV interfaces

Route selection is a regulatory strategy decision. Consider product eligibility, target territories, existing authorisations, legal basis, development timing, evidence package, language and local implementation.

For pharmacovigilance, maintain a procedure map showing:

• authorisation route and product status;
• RMS, CMS, national competent authorities and EMA interfaces;
• product information versions and effective dates;
• reporting and communication responsibilities;
• PSUR or other aggregate-reporting procedures;
• signal and referral linkages;
• local service providers and escalation paths.

Disagreements and referrals

In MRP or DCP, a Member State may raise a serious potential risk to public health or disagree with the assessment. The issue is handled through the applicable coordination and referral mechanisms. CMDh is the relevant coordination group for human medicines authorised through national routes; CHMP is the scientific committee for centralised products and certain EU referrals.

Do not describe every procedural disagreement as an Article 29 referral. The legal route, product type and issue determine the mechanism. Article 29(4) is associated with disagreement over a potential serious risk to public health in MRP/DCP; other referral provisions address different questions. Always check the current legal text and procedural guidance.

Terminology that prevents confusion

• RMS: Reference Member State coordinating an MRP or DCP.
• CMS: Concerned Member State participating in an MRP or DCP.
• CMDh: Coordination Group for Mutual Recognition and Decentralised Procedures — Human.
• CHMP: EMA committee responsible for scientific opinions on human medicines in its remit.
• CAP: Centrally authorised product.
• NAP: Nationally authorised product.
• MAH: Marketing authorisation holder.
• SmPC: Summary of product characteristics.

References

• European Commission, National authorisation procedures
• European Commission, Decentralised procedure
• EMA, Marketing authorisation
• EMA, CMDh regulatory and procedural guidance
• European Commission, Notice to applicants, Volume 2A
• Directive 2001/83/EC

Regulatory Note

Procedure names, legal bases, referral provisions and territorial arrangements are jurisdiction- and product-specific and can change with legislation. This article provides a working comparison, not legal advice. Confirm the current EMA, CMDh, European Commission and national guidance before making a regulatory submission.