Getting a drug to market in the EU requires a marketing authorisation — a formal approval from regulatory authorities confirming that the product’s quality, safety, and efficacy have been assessed and found acceptable. Unlike the US, where FDA issues a single national approval, the EU has multiple authorisation procedures, each with different scope, timeline, and strategic implications.

Choosing the right procedure is one of the first and most consequential regulatory decisions a pharmaceutical company makes when entering the EU market.

What Is a Marketing Authorisation?

A marketing authorisation (MA) — called a marketing authorisation application (MAA) at the application stage — is the regulatory approval required to place a medicinal product on the EU market. It is issued by either the European Commission (for centrally authorised products) or national competent authorities (for nationally authorised products).

The legal basis for EU marketing authorisations is Directive 2001/83/EC (for human medicines) and Regulation (EC) No 726/2004 (for the centralised procedure). The application dossier follows the Common Technical Document (CTD) format, which is also used in the USA, Canada, Japan, and other ICH member countries.

The Four EU Authorisation Procedures

1. Centralised Procedure (CP)

Managed by: European Medicines Agency (EMA)
Result: Single EU-wide marketing authorisation, valid in all 27 EU member states plus Iceland, Liechtenstein, and Norway
Timeline: 210 active days (approximately 12–15 months including clock stops)

The centralised procedure is mandatory for:

Biotechnology-derived products (recombinant DNA, monoclonal antibodies, etc.)
Advanced therapy medicinal products (ATMPs: gene therapy, somatic cell therapy, tissue-engineered products)
Orphan medicines (products for rare diseases)
Products for HIV/AIDS, cancer, diabetes, neurodegenerative diseases, autoimmune diseases, and other serious conditions (if they contain a new active substance)
Products designated as orphan medicines

The centralised procedure is optional for:

Products containing a new active substance not covered by mandatory scope
Products that constitute a significant therapeutic, scientific, or technical innovation
Products where a centralised authorisation is in the interest of patients at EU level

How it works: EMA appoints a rapporteur and co-rapporteur from its Committee for Medicinal Products for Human Use (CHMP). The rapporteur leads the scientific assessment; the co-rapporteur provides a second opinion. The CHMP issues an opinion (positive or negative), and the European Commission issues the marketing authorisation based on that opinion.

Cost: EMA charges application fees for centralised procedure applications. Standard fees for a full application are approximately €301,000 (2024 fee schedule). Reduced fees apply for SMEs, orphan medicines, and generic applications.

2. Decentralised Procedure (DCP)

Managed by: National competent authorities (NCAs) of participating member states
Result: National marketing authorisations in all participating member states
Timeline: 210 active days (similar to CP, but with different clock stop dynamics)

The decentralised procedure is used for products not eligible for or not seeking centralised authorisation. The applicant selects:

A Reference Member State (RMS): The member state that leads the scientific assessment
Concerned Member States (CMS): The other member states where authorisation is sought

The RMS prepares an Assessment Report, which is circulated to all CMS. CMS can raise concerns (Requests for Supplementary Information, RSIs). If all concerns are resolved, all participating member states grant national authorisations simultaneously.

Strategic considerations for RMS selection:

France (ANSM): Strong scientific expertise, particularly in oncology and rare diseases. French language requirements for some documentation.
Germany (BfArM/PEI): Rigorous assessment, strong in biologics and vaccines (PEI). Large market.
Netherlands (MEB/CBG): Known for efficient assessment and pragmatic approach. Popular choice for first-time EU applicants.
Sweden (MPA): Efficient, English-language friendly, strong in generics.

3. Mutual Recognition Procedure (MRP)

Managed by: National competent authorities
Result: National marketing authorisations in additional member states
Timeline: 90 active days

The MRP is used when a product already has a national marketing authorisation in one EU member state and the applicant wants to extend it to other member states. The existing national authorisation is the basis for the application; other member states are asked to recognise it.

The MRP is faster than the DCP (90 days vs. 210 days) because the scientific assessment has already been completed. However, CMS can raise concerns about the existing assessment, which can trigger a referral to the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh).

4. National Procedure

Managed by: Single national competent authority
Result: Marketing authorisation in one EU member state only
Timeline: Varies by member state (typically 6–12 months)

The national procedure is used for products intended for a single EU member state. It is less common for new innovative products but is used for:

Products with a purely national market
Traditional herbal medicinal products (THMPs) under Directive 2004/24/EC
Homeopathic products under simplified registration procedures

Comparison: Which Procedure Is Right for Your Product?

Factor	Centralised	Decentralised	Mutual Recognition	National
Geographic scope	All EU + EEA	Selected member states	Additional member states	Single country
Mandatory for	Biotech, ATMPs, orphans, certain new substances	Products not eligible for CP	Products with existing national MA	Single-country products
Timeline	~12-15 months	~12-15 months	~6-9 months	6-12 months
Cost	€301,000+ (EMA fee)	National fees (variable)	National fees (lower)	National fees
Strategic advantage	Broadest market access, single assessment	Flexibility in RMS selection	Fastest expansion	Simplest process

The CTD Dossier: What You Need to Submit

Regardless of the procedure chosen, the marketing authorisation application must be submitted in CTD format. The CTD has five modules:

Module 1: Administrative information — application forms, product information (SmPC, labelling, package leaflet), expert reports

Module 2: CTD summaries — quality overall summary, non-clinical overview and summaries, clinical overview and summaries

Module 3: Quality — drug substance (chemistry, manufacturing, characterisation, specifications, stability) and drug product (formulation, manufacturing, specifications, stability)

Module 4: Non-clinical study reports — pharmacology, pharmacokinetics, toxicology

Module 5: Clinical study reports — clinical pharmacology, efficacy studies, safety studies, post-marketing data

For a new chemical entity, preparing a complete CTD is a multi-year, multi-million euro undertaking. For a generic product, Module 4 is largely replaced by a bioequivalence study, and Module 5 is replaced by a reference to the originator’s clinical data.

Post-Approval Obligations

A marketing authorisation is not a one-time approval. Post-approval obligations include:

Variations: Any change to the approved product (formula, manufacturing process, specifications, labelling) requires a variation application — Type IA (minor, notify), Type IB (minor, notify and wait), or Type II (major, full assessment)
Renewal: Marketing authorisations must be renewed after 5 years; after renewal, they are valid indefinitely (subject to conditions)
Pharmacovigilance: Ongoing safety monitoring, PSUR submission, signal detection, and risk minimisation measures
Post-authorisation studies: Conditions attached to the authorisation may require post-authorisation efficacy studies (PAES) or post-authorisation safety studies (PASS)

At Care Europe, we support pharmaceutical companies through the full EU marketing authorisation process — from regulatory strategy through submission management and post-approval lifecycle. Contact us at [email protected].

Marketing Authorisation in Europe: Centralised vs Decentralised Procedure