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Marketing authorisation holders

Medicines shortages

Notify the HPRA of a shortage and learn how shortages are managed

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Fees

Download the fee application form and the guide to fees charged by the HPRA

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Legislation

List of legislation governing the regulation of medicines for human use

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Scientific and regulatory advice

Submit questions about regulatory aspects of developing a new or existing medicine

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Guidance documents

Download guides for regulatory procedures

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Medicinal Products Newsletter

Download our medicinal products newsletters from 2022-2024.

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