Manufacturers

Regulation of manufacturing

How manufacturers are regulated and the type of activities that are regulated

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MIA variations

Apply for a variation to a manufacturer's authorisation

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GMP inspections

HPRA inspections assess compliance with Good Manufacturing Practice standards

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Legislation

List of legislation governing the regulation of medicines for human use.

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New MIA applications

Apply for a manufacturer's authorisation

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MIA transfers

Apply for the transfer of a manufacturer's authorisation

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Fees

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

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