A national procedure submission targets marketing authorisation in one or more individual EU member states, while a centralised procedure submission goes through the European Medicines Agency and results in a single authorisation valid across all EU and EEA countries. The right choice depends primarily on your product type, your target markets, and whether centralised submission is mandatory or optional for your product category. The sections below break down each procedure, how they compare, and what to consider when planning your regulatory strategy.
Which EU approval procedure should you use for your product?
The procedure you use depends on whether centralised submission is mandatory, optional, or unavailable for your product. Certain product categories must go through the centralised procedure, others may choose it voluntarily, and some products are only eligible for national routes. Understanding which category your product falls into is the essential first step in planning your regulatory submissions.
The centralised procedure is mandatory for biotechnology-derived medicines, advanced therapy medicinal products (ATMPs), orphan medicines, and products for HIV, cancer, diabetes, neurodegenerative diseases, and several other serious conditions. If your product does not fall into a mandatory category, you may still opt in voluntarily if it represents a significant therapeutic innovation or offers a benefit to patients at the EU level.
Products that do not qualify for the centralised procedure must use one of the national routes: the mutual recognition procedure (MRP), the decentralised procedure (DCP), or a purely national application in a single member state. Choosing the right route early avoids costly rerouting later in development. Our regulatory submission services cover all available EU procedures, helping you identify the most appropriate pathway from the outset.
What is the centralised procedure and how does it work?
The centralised procedure is a single EU-wide marketing authorisation pathway coordinated by the European Medicines Agency (EMA). A company submits one application to the EMA, two scientific committees assess it, and if approved, the resulting marketing authorisation is valid in all EU member states plus Iceland, Liechtenstein, and Norway simultaneously.
The process begins with pre-submission meetings and the appointment of a rapporteur and co-rapporteur from the Committee for Medicinal Products for Human Use (CHMP). The CHMP then conducts a 210-day scientific review, during which the applicant responds to questions and provides clarifications. Clock stops can extend the total timeline, but the procedure ultimately results in a single European Commission decision that grants or refuses the authorisation.
One of the key advantages of the centralised route is that it eliminates the need to manage separate national dossiers and timelines. Once the Commission decision is issued, the product can be commercialised across the entire EU without further national steps, making it the most efficient path for companies targeting multiple European markets from launch.
What are national procedures for marketing authorisation in the EU?
National procedures are marketing authorisation routes managed by individual EU member state competent authorities rather than by the EMA. They include purely national applications, the mutual recognition procedure (MRP), and the decentralised procedure (DCP). These routes are used for products that do not qualify for, or choose not to use, the centralised procedure.
A purely national application is submitted to a single member state and results in an authorisation valid only in that country. This route is suitable when a company intends to market a product in one country only, or when testing a market before broader EU expansion. It is also the starting point for MRP, since MRP requires an existing national authorisation as its foundation.
National procedures give companies more direct interaction with individual national competent authorities, which can be an advantage when a product has characteristics that require close dialogue with a specific regulatory body. However, managing multiple national procedures in parallel adds complexity and resource requirements compared to a single centralised submission.
What’s the difference between MRP and DCP in national submissions?
The key difference is the starting point. The mutual recognition procedure (MRP) begins after a product already holds a national marketing authorisation in one member state, which then acts as the reference member state (RMS). The decentralised procedure (DCP) starts simultaneously across multiple countries, with no prior national authorisation required.
Mutual Recognition Procedure (MRP)
In MRP, the company first obtains a national authorisation in the reference member state. It then asks other concerned member states (CMS) to recognise that authorisation. The RMS prepares an updated assessment report, and the CMS have 90 days to agree or raise objections. MRP is a practical route when a company already has an approved product in one EU country and wants to expand its reach without starting from scratch.
Decentralised Procedure (DCP)
DCP runs in parallel across all selected member states from the outset. The applicant designates one country as the RMS, which leads the assessment over a 210-day procedure, while CMS participate simultaneously. DCP is typically chosen when no national authorisation exists yet and the company wants to launch in several EU markets at the same time. It is generally more efficient than running sequential national applications and avoids the prerequisite of an existing authorisation.
Can a product switch from a national to a centralised procedure?
Switching from a national or MRP/DCP authorisation to the centralised procedure is not straightforward and is generally not permitted for the same product. The EMA does not accept centralised applications for products that already hold national authorisations in EU member states, as the two systems are designed to be mutually exclusive. However, there are specific circumstances where a transition is possible.
If a product undergoes significant development, such as a new indication that falls under a mandatory centralised category, or if it qualifies as an ATMP following reformulation or reclassification, a new centralised application may be appropriate. In practice, this means submitting a new application rather than converting an existing one, and the national authorisations would typically need to be withdrawn.
Companies planning long-term EU commercialisation should therefore think carefully about procedure selection early in development. Choosing a national route for speed or simplicity in one market can create regulatory constraints later if broader EU access becomes the goal. Strategic planning at the pre-submission stage avoids these complications. To learn more about how Starodub approaches these strategic decisions, visit our company page.
How do timelines and costs compare across submission procedures?
The centralised procedure and DCP both operate on a 210-day active review clock, while MRP runs on a 90-day recognition phase following an existing national authorisation. In practice, clock stops, questions from assessors, and procedural negotiations mean total elapsed time often exceeds the theoretical minimum for all routes. Costs and resource requirements vary considerably depending on the route and the number of markets targeted.
The centralised procedure carries EMA application fees, which are substantial but can be reduced for small and medium-sized enterprises and for orphan medicinal products. The benefit is a single set of fees for EU-wide access. National procedures involve fees paid to each member state competent authority, which accumulate quickly when multiple countries are involved, and each authority may request country-specific translations, labelling adaptations, or additional data.
From a resource perspective, the centralised procedure demands intensive preparation of a single high-quality dossier and close management of EMA interactions. National procedures distribute effort across multiple authorities and timelines, which can strain internal regulatory teams. For companies with limited resources targeting a small number of markets, a well-managed DCP or MRP can be more cost-effective than a centralised submission, provided the product is eligible for those routes.
How Starodub supports your EU regulatory submission strategy
Selecting and executing the right EU submission procedure is one of the most consequential decisions in a product’s path to market. We work with biopharmaceutical and medical device companies at every stage of that process, from initial procedure selection through to authorisation and post-approval maintenance.
Our support across regulatory submissions includes:
- Procedure eligibility assessment to determine whether the centralised procedure is mandatory, optional, or unavailable for your specific product
- Strategic advice on MRP versus DCP based on your target markets, existing authorisations, and commercial timelines
- Dossier preparation and gap analysis to ensure your submission meets EMA or national competent authority requirements from the outset
- Regulatory project management including coordination with rapporteurs, reference member states, and concerned member states throughout the review process
- Post-authorisation support for variations, renewals, and label updates across all relevant member states
With over 400 completed projects and more than 300 clients supported, we bring hands-on experience across the full spectrum of EU approval procedures. If you are planning a submission or reassessing your current regulatory strategy, contact Starodub to discuss how we can support your path to EU market authorisation.
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