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Drug and Health Product Licence

Approval to sell medicines, devices and health products. Handled by the Health Products Regulatory Authority (HPRA).

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Official program name
Drug and Health Product Licence
Program category
Drug and health licences
Regulator
The Health Products Regulatory Authority (HPRA)
What it covers
Approval to import, distribute or sell medicines, medical devices, supplements and other health products.
Who needs it
Companies selling pharmaceuticals, devices, supplements or other regulated health products.
Typical documents
Product dossier, manufacturing details, safety and quality data, labelling and the licence holder details.
Processing time
To be confirmed. Confirm with the regulator.
Official source
hpra.ie

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.