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Marketing authorisation holders

New applications

Authorisation of new products, including herbal and homeopathic medicines

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Medicines shortages

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

Report
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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Post licensing

Procedures for products already on the market, including renewals and variations

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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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