Drug Registration in Europe: Complete Guide to EMA Approval – Centralized, Decentralized, MRP & National Procedure
Last Updated: September 2026 | By PharmaShare.in – Regulatory Affairs Simplified
Legal Basis for Applications in Europe: Article 8(3) and Article 10
The eligibility and requirements are set in the Commission Regulation (EC) No 726/2004 and defined in the Article 8 and 10 of the Directive 2001/83/EC. Article 8(3) and Article 10 are for full applications (NDA) and abridged applications respectively.
Article 8(3) – Full Application (Equivalent to US NDA)
For New Chemical Entities (NCE). Requires full CTD data – Quality (Module 3), Non-clinical (Module 4), Clinical (Module 5).
Article 10 – Abridged Applications for Generics (Most Important for Generics)
- Article 10(1) Generic Application: Equivalent to US ANDA 505(j). For drugs where bioequivalence is proven against a Reference Medicinal Product authorized for 8+ years in EU. No preclinical/clinical needed.
- Article 10(3) Hybrid Application: Equivalent to US 505(b)(2). When your product does not meet strict generic definition – different strength, dosage form, route, indication, or BE cannot be demonstrated by standard studies.
- Article 10(4) Biosimilar: Similar biological medicinal product.
- Article 10a Well-Established Use: 10+ years of well-established use in EU based on literature.
- Article 10b Fixed Dose Combination: New combination of already approved actives.
The 4 Types of Marketing Authorization Procedures in Europe
1. Centralized Procedure (CP): One Application, 27 Countries
European Council lays down a centralized procedure for which there is a single application, a single evaluation and a single authorization allowing direct access to the single market of 27 countries. Governed by EMA/CHMP.
- Developed by biotechnological processes (recombinant DNA, monoclonal antibodies)
- New active substance for: AIDS, Cancer, Diabetes, Neurodegenerative disorder, Auto-immune disease, Viral disease
- Orphan drugs for rare diseases
- Advanced Therapy Medicinal Products (ATMPs)
- New chemical, biological or radiopharmaceutical active substance
- An isomer, mixture of isomers, complex or derivative or salt
- Significant therapeutic, scientific or technical innovation
- Generic/Hybrid of a Centrally Authorized product (Article 3(2))
- Certain medicinal products for pediatric use (PUMA)
Timeline: 210 days evaluation + clock stops for queries.
2. National Authorizations
Member states are responsible for granting marketing authorizations for medicinal products which are placed on their markets, except for medicinal products which are authorized through centralized procedure. To obtain a national marketing authorization, an application must be submitted to the particular Member State.
Best for: Launching in only ONE country e.g., only Germany or only France.
3. Decentralized Procedure (DCP) – The Workhorse for Generics
If no marketing authorization has been granted in the Community, the applicant may make use of a decentralized procedure and submit an application to all the Member States where it intends to obtain authorization at the same time, and choose one of them as Reference Member State (RMS).
Based on the assessment report prepared by the RMS and any comments made by the Concerned Member State (CMS), marketing authorization should be granted.
Best for: 90% of generic companies. When you want to enter 5-10 EU markets together in one shot (e.g., DE, FR, ES, IT, PT).
4. Mutual Recognition Procedure (MRP)
If the applicant has marketing authorization in one Member State and wishes to obtain the same in other Member states, MRP is followed. This procedure is based on the mutual recognition by Concerned Member State(s) of a national marketing authorization granted by the Reference Member State.
Best for: Expansion strategy. You first got approval in Germany via National, now you want to expand to Spain, Italy using MRP.
At the end of both MRP and DCP with a positive agreement, a national marketing authorization will be issued in individual Member States.
Comparison Table: Type of Procedure in Europe
| Agencies Responsible | Procedure Type | Products Applicable |
|---|---|---|
| EMA / CHMP | Centralized Procedure | Mandatory Scope (Article 3(1)) – Biotech, New active substance for AIDS, Cancer, Diabetes, Neurodegenerative, Auto-immune, Viral disease, Orphan drugs.
Optional Scope (Article 3(2) & 3(3)) – New chemical/biological, Innovation, Generic/Hybrid of Centralized, Pediatric (PUMA) |
| RMS / CMD(h) / CHMP | Decentralized Procedure (DCP) and Mutual Recognition (MRP) | For drugs which does not fall in the mandatory scope of Centralized procedure. Main route for generics. |
| Member States (MS) | National Marketing Authorization | For drugs which does not fall in the mandatory scope of Centralized procedure. Single market entry. |
EMA – European Medicines Agency; CHMP – Committee for Medicinal Products for Human Use; RMS – Reference Member States; CMD(h) – Co-ordination Group for Mutual Recognition and Decentralized Procedure (Human)
Strategic Tips for Generic Filing in Europe
Frequently Asked Questions (FAQs)
Q1. What are the 4 types of marketing authorization procedures in Europe?
The four procedures are Centralized Procedure (CP) for 27 countries via EMA, Decentralized Procedure (DCP) for simultaneous filing in multiple countries, Mutual Recognition Procedure (MRP) for expansion after national approval, and National Procedure for single country filing.
Q2. What is the difference between DCP and MRP in Europe?
In DCP, no marketing authorization has been granted in the Community and you apply to all member states at the same time. In MRP, you already have marketing authorization in one member state (RMS) and you ask other member states (CMS) to mutually recognize it.
Q3. When is Centralized Procedure mandatory in Europe?
Centralized is mandatory for products developed by biotechnology, new active substances for AIDS, Cancer, Diabetes, Neurodegenerative disorder, Auto-immune disease, Viral disease, Orphan drugs and ATMPs under Article 3(1) of Regulation (EC) No 726/2004.
Q4. What is Article 8(3) and Article 10 in Europe?
Article 8(3) is a full application for new chemical entities with complete data (like US NDA). Article 10 is for generic/hybrid applications – 10(1) is generic (like US ANDA), 10(3) is hybrid (like US 505(b)(2)), 10(4) is biosimilar.
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About the Author
Mahummed Asif is a experienced pharmaceutical Quality Assurance professional and publisher of Pharmashare. He has worked with leading Pharmaceutical organizations and has developed extensive expertise in Quality Assurance, deviation management, investigations, CAPA, QMS, Product Life Cycle Management, change control, risk management, validation, product complaints, product recalls, and regulatory compliance. He is passionate about sharing practical pharmaceutical knowledge with professionals, students, and quality practitioners across the industry.