HPRA – Guide to New applications and variations to Manufacturer’s Authorisations

This document provides guidance on applying to the HPRA for a new manufacturer’s authorisation or to vary an existing manufacturer’s authorisation. This guide should be read in conjunction with other stated forms.

A number of sections of the Manufacturing and Importation Authorisation (MIA) have been described, such as the applicant details and the content of the appendices. These three appendixes available at the end of this document provide detailed guidance on the supporting information required for the inclusion of contract sites based in MRA (mutual recognition agreement) partner territories , on the import or supply of unlicensed/exempt medicinal products for the Irish market and guidance regarding Qualified Person declarations.


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