Advanced Therapy Medicinal Products advice form : MHRA

Contact details


Contact name*			Title*
Correspondence address*
Postcode*
Telephone
Email address*
Confirm email address*

Company / enquirer details


Reference
Company name*
Company address*

Proposed product*


Proposed product name or identifier ¹
Product form (e.g. tablet, capsule, cream etc)
Short descriptor of the proposed active substance ²
Brief description of the proposed finished product ³
Proposed indication and claims for the product
Source of the human tissue i.e. autologous, allogeneic
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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.

Scientific aspects

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)
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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
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Mechanism of action / proposed use*


Claimed mechanism of action
Properties (including pharmacological, immunological or metabolic, if applicable)
Proposed use / indication (including therapeutic, prophylactic, diagnostic)
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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)
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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
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Other aspects / bibliography


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Advanced therapy medicinal products advice form