##  [Informed Consent Applications in Mutual Recognition and Decentralised Procedures](/index%2ephp/mandate/informed-consent-applications-in-mutual-recognition-and-decentralised-procedures) 

November 7, 2025

Regulatory issues for informed consent applications, with Article 10c of Directive 2001/83/EC allowing pharmaceutical, preclinical, and clinical documentation.

It covers various aspects, which are mentioned below: 

- Introduction:  
    
    - Document aims to streamline regulatory issues for informed consent applications
- Legal framework:  
    
    - Article 10c of Directive 2001/83/EC allows the use of pharmaceutical, preclinical, and clinical documentation for marketing applications, provided consent is obtained for all three modules
- Definition of the reference product and informed consent applications:  
    
    - The CMDh defines a reference product as a Marketing Authorization Holder (MAH) for a medicinal product with a complete dossier
    - Informed consent applications are required, with the same composition and pharmaceutical form as the reference product
    - The informed consent application follows the same authorization route as the initial authorization
- Dossier requirements:  
    
    - Applicant should contact national competent authorities for dossier requirements
    - If modules other than module 1 are submitted, they must be identical to the reference product dossier
- Guidance for different situations:  
    
    - Directive 2001/83/EC allows two situations for applying for marketing authorization for a product through an application based on Article 10c
    - The first involves submitting an informed consent application nationally in the Reference Member State for A, while the second involves initiating a mutual recognition/decentralized procedure with the same RMS
    - Failure to withdraw the national application may trigger Article 18 and invalidate the application
- Maintenance of the dossier following granting of the informed consent marketing authorization:  
    
    - Marketing authorization under Article 10c of the 2001/83/EC Directive allows independent changes to the product, allowing variations without identicality, and requiring data submission



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Source

[https://www.hma.eu/fileadmin/dateien/Human\_Medicines/CMD\_h\_/procedural\_guidance…](https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/Amended_Variation_Regulation/CMDh_070_1999_Rev7_2025_10_clean_-_Recommendations_on_informed_consent_applications_in_MRP_DCP.pdf)

 

 

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