Using a Third-Party MIA Licence Holder When You Have No EU Site
Your product is made outside the EU, and you want to supply it to EU patients. You have no EU legal entity, no warehouse and no Qualified Person (QP). To import medicines into the EU, a site needs a manufacturing and importation authorisation (MIA), often called an MIA licence. A non-EU company does not have […]
What Happens After Your Product Arrives in Ireland? The Critical Steps Before QP Certification
What happens after a medicinal product arrives in Ireland? Learn how quarantine, documentation, testing and QP certification fit together before a batch can be released for sale or supply.
How Long Does EU Pharmaceutical Batch Release Take?
How long does EU pharmaceutical batch release take? This is one of the most practical questions non-EU Marketing Authorisation Holders and clinical trial sponsors ask once the product has arrived in Ireland. There is no fixed regulatory deadline. EU legislation does not prescribe a maximum or minimum number of days for Qualified Person (QP) certification. […]
MIA Application in Ireland: Requirements, Process and Timeline
If your company plans to manufacture medicinal products in Ireland, or import them from a third country into Ireland, you will typically need to establish the relevant manufacturing or import authorisation before those activities begin. In most cases, that means securing a Manufacturer’s/Importer’s Authorisation (MIA) from the Health Products Regulatory Authority (HPRA). The requirement itself […]
Contamination Control Strategy: EU GMP Annex 1 Guide
A contamination issue is rarely caused by one failed control. A trend in environmental monitoring, a cleaning deviation, a change to equipment — on their own, each looks manageable. The real challenge is seeing how they connect. This is where a Contamination Control Strategy (CCS) comes in. It brings together the controls that prevent microbial, […]
Complete QP Certification and Batch Release Guide That Guarantees Inspection Success
Introduction: What QP certification and batch release really means in the EU Do you need to understand QP certification and batch release? If you manufacture or import medicinal products in the EU, you have probably heard that no batch can be sold without EUQP certification and batch release. But what does EUQP certification and batch […]