*Company name

*Title

*First name

*Surname

*Phone number

*Email address

*Confirm email address

*Postal address

*City

*Post code

*Country

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

1. If the product name is not available, use an adequate identifier (e.g. company internal code).
2. The descriptor should identify the key identifying features of the active substances such as, depending on its nature, the gene to be transferred, vector, cells or tissues.
3. Including, when applicable, devices/structural components being an integral part of the product.

Active Substance

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)

Proposed indication and claims for the product

Proposed indication and claims for the product

Finished product

Qualitative and quantitative composition

Mode of administration

Pharmaceutical form (use standard term as applicable) and description of the finished product ready for clinical use

Mechanism of action / proposed use

Claimed mechanism of action

Properties (including pharmacological, immunological or metabolic, if applicable)

Proposed use / indication (including therapeutic, prophylactic, diagnostic)

Summary of the status of the development of the product

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)

Regulatory status and current medical use

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

Other aspects / bibliography