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Medicines authorisation - information for patients and healthcare professionals

How medicines are authorised in Ireland

Find out how companies apply for authorisation of a new medicine

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Biosimilar medicines

FAQs for patients and guidance for healthcare professionals on prescribing and dispensing biosimilars.

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Vaccines for human use

Links to other organisations providing guidance on using vaccines in Ireland

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Herbal medicines

How herbal medicines are authorised for use in Ireland

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Early access to medicines

In certain cases, patients can use unauthorised medicines if there are no suitable authorised ones available.

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