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Regulation – Medicines for human use

Marketing authorisation holders

Submit applications to the HPRA and find guidance for regulatory procedures

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Wholesalers and retailers

Regulatory guidance for buying, storing and selling medicines

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Patients and healthcare professionals

Learn how medicines are regulated and how shortages are managed

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Manufacturers

Applications for MIAs and information about GMP inspections

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Sponsors of clinical trials

Applying to run a clinical trial and complying with safety requirements

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