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Product Trial and Sample Approval

Approval to trial a new product before launch. Handled by the Spanish Agency of Medicines and Medical Devices (AEMPS).

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Official program name
Product Trial and Sample Approval
Program category
Product trials
Regulator
The Spanish Agency of Medicines and Medical Devices (AEMPS)
What it covers
Permission to test a new product in the market. Depending on the product this can mean importing trial samples, a clinical or field trial approval or a regulatory sandbox.
Who needs it
Companies launching a new product that need to test it before a full launch.
Typical documents
Trial plan, product information, safety data, importer details and any ethics or authority approvals the trial needs.
Processing time
To be confirmed. Confirm with the regulator.
Official source
aemps.gob.es

Want more background?

Our guide explains how this route works in practice and what to prepare first.

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Directional guidance only, not legal advice. Requirements depend on your product and change often. Confirm current rules and fees with the regulator before you apply.