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Manufacturing of veterinary medicines in Ireland 

Regulation of manufacturing

Steps involved in the manufacturing of medicines including how they are regulated and what exemptions are allowed.

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Application for a variation

Guidance on applying for a variation when there are proposed changes to the authorised manufacturing site.

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Application for a withdrawal

How to withdraw a manufacturer's authorisation and when is best to do this.

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MIA authorisations

Requirements and application process for manufacturing and/or importation authorisation (MIA) of a medicine.

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Application for a transfer

When to submit an application for transferring ownership of an MIA and how to do it.

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GMP inspections

What is involved in the Good Manufacturing Process inspections.

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