Operate · EU regulatory
EU Regulatory Pathways for Marketing Authorisation
The legal bases for an EU marketing authorisation application, what each one relies on, and what the signed Clinical and Nonclinical Expert Reports must cover under Directive 2001/83/EC.
Comparison
EU application types, side by side.
| Application type | What it relies on | Module 2 Expert Reports |
|---|---|---|
| Full application (Article 8(3)) | Complete EU marketing authorisation application with the applicant's own quality, nonclinical and clinical data. | Clinical Overview (2.5) and Nonclinical Overview (2.4) critically assessing Modules 4 and 5, aligned with Module 3. |
| Generic application (Article 10(1)) | Relies on the reference medicinal product's data once data exclusivity has expired, supported by bioequivalence. | Overviews focused on bioequivalence, impurities and any differences from the reference product. |
| Hybrid application (Article 10(3)) | Based on a reference product but with changes such as a new strength, pharmaceutical form, route or indication. | Overviews that justify each difference and assess the bridging data that supports it. |
| Well-established use (Article 10a) | Bibliographic application for an active substance in well-established medicinal use in the EU for at least ten years. | Literature-based Overviews demonstrating recognised efficacy and an acceptable level of safety. |
| Fixed combination (Article 10b) | New combination of active substances already used in authorised medicinal products. | Overviews covering the rationale for the combination and new data on the combination itself. |
| Type II variations | Major changes to an existing marketing authorisation, including new indications and formulation changes. | New or updated Expert Reports covering the data that supports the change. |
Always confirm current requirements in EMA and national competent authority guidance before filing.
Guides
EU regulatory guides and insights.
Insight
What a Clinical Overview Must Contain for an EU Hybrid Application
Insight
Well-Established Use Applications: Building a Bibliographic Clinical Overview That Holds Up
Insight
How to Choose an Independent Clinical Expert for Your EU Dossier
Expert reports
Signed Clinical (2.5) and Nonclinical (2.4) Expert Reports
FAQ
EU regulatory questions.
Which legal basis applies to my EU marketing authorisation application?
It depends on the data you hold. Full applications use your own data (Article 8(3)), generics rely on a reference product (Article 10(1)), hybrids add changes to a reference product (Article 10(3)) and well-established use applications rely on published literature (Article 10a).
Who must sign the Clinical and Nonclinical Overviews?
Article 12 of Directive 2001/83/EC requires the Overviews to be drawn up and signed by experts with the necessary technical or professional qualifications, with a brief CV attached.
Is the centralised or national procedure right for my product?
The centralised procedure through EMA is mandatory for biotechnology products, advanced therapies and certain therapeutic areas. Other products can use the decentralised, mutual recognition or national procedures.
Does PXM write Module 2 Expert Reports?
Yes. Neta Kela, PhD writes and signs the Clinical Overview (2.5) and Nonclinical Overview (2.4) as named expert for full, hybrid and well-established use applications and variations.