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Ireland's guidance on New Application & Variations, Registartion Requirements,

Irelands HPRA released a few guidances in the past week

This document provides guidance on applying to the HPRA for a new manufacturer’s authorisation or to vary an existing manufacturer’s authorisation.


There are three types of manufacturer’s authorisations:

  1. Manufacturer’s authorisation for medicinal products for human use

  2. Manufacturer’s authorisation for investigational medicinal products for human use

  3. Manufacturer’s authorisation for medicinal products for veterinary use

Applicants who wish to apply for a manufacturer’s authorisation should review all sections of this guidance. Relevant documentation as described must be provided with the application to support any entries in the Annexes.

The purpose of this document is to provide guidance on the registration process for active substance manufacturers, importers and distributors in Ireland. It covers the criteria for registration as set out in Falsified Medicines Directive (FMD) and provides guidance on the administrative and technical aspects of the registration scheme and the processes for making an application to the Health Products Regulatory Authority (HPRA) for registration.

The requirements of the FMD do not apply to active substances used for manufacture of investigational medicinal products for human and veterinary use, medical devices or to veterinary medicines

Changes can occur at facilities (e.g. the introduction of the manufacture of new active substances) which can potentially have a quality and safety impact. Therefore, it is important that such changes are managed through the formal application of change control and risk management, where appropriate.

The Falsified Medicines Directive (FMD) governing medicinal products for human and veterinary use, and requires that manufacturers, importers and distributors of active substances ‘maintain’ their registration with the local competent authority.

Check out this guide to know detailed information.

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