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Regulation of medicines for human use - information for patients and healthcare professionals

Shortages of medicines

Report a shortage and find out how shortages are managed in Ireland

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Generic and interchangeable medicines

Patient information about how generics compare to original medicines, and a guide for HCPs on the interchangeables list.

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Medicines authorisation

Companies can choose one of three procedures to apply for authorisation of a medicine.

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Herbal medicines

How herbal medicines are authorised for use in Ireland

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Vaccines for human use

Links to other organisations providing guidance on using vaccines in Ireland

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Clinical trials

Find a clinical trial in Ireland, and find out how new laws are improving trials in Europe

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Biosimilar medicines

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

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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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Emergency medicines

Register to hold a medicine on your premises for emergency use

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