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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