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*Phone number
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Reference
Company name
Company address
Proposed product name or identifier1
Product form (e.g. tablet, capsule, cream etc)
Short descriptor of the proposed active substance2
Brief description of the proposed finished product3
Proposed indication and claims for the product
Source of the human tissue i.e. autologous allogeneic
Description of active substance (including starting materials, when relevant)
Description of any additional substances (e.g. when applicable: structural component such as scaffolds, matrices, biomaterials, biomolecules and/or other components)
Description of medical device or active implantable medical device (when applicable)
Qualitative and quantitative composition
Mode of administration
Pharmaceutical form (use standard term as applicable) and description of the finished product ready for clinical use
Claimed mechanism of action
Properties (including pharmacological, immunological or metabolic, if applicable)
Proposed use / indication (including therapeutic, prophylactic, diagnostic)
Full details of the manufacturing process
Key elements of manufacturing, quality aspects (including description and level of manipulations on cells and tissues, when applicable – see Reg. 1394/2007, Annex I)
Outline of non-clinical development
Outline of clinical development (note: specify the current stage of development)
Details of regulatory status (including medical (active implantable) device, when applicable) and marketing history in EU and non EU countries
Current medical use worldwide
Has advice been sought from other regulatory authorities? If yes, please provide a copy of the determination
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