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Brexit Revisited – Are you prepared for the Windsor Framework?

Brexit Revisited – Are you prepared for the Windsor Framework?

by elena@investinu.ie | Jun 4, 2024 | Acorn Regulatory News, Brexit

More than 4 years after the United Kingdom’s exit from the EU in January 2020, the industry is still dealing with the impact of Brexit and the Northern Ireland Protocol. Most recently being the implementation of the Windsor Framework. In March 2023 the EU-UK Joint...
BioPharmaChem Impact 24 Conference

BioPharmaChem Impact 24 Conference

by elena@investinu.ie | May 24, 2024 | Acorn Regulatory News

We were delighted to attend the 1st ever BioPharmaChem Impact 24 Conference which took place yesterday May 23rd in the beautiful surroundings of Fota Island Resort, Cork. This event brought together over 180 delegates from a diverse group of stakeholders to facilitate...
New Guidelines for Environmental Risk Assessment of Medicinal Products: What You Need to Know

New Guidelines for Environmental Risk Assessment of Medicinal Products: What You Need to Know

by elena@investinu.ie | Apr 10, 2024 | Acorn Regulatory News

Guidelines on the Environmental Risk Assessment (ERA) of Medicinal Products for human use EMEA/CHMP/SWP/4447/00 Rev.1 issued on the 15th February 2024 replaces EMEA/CHMP/SWP/4447/00 Corr 2 which has been in effect since 2006.  The updated procedure comes into effect...
HPRA Rolls Out Revised ‘Guide to Renewal of Marking Authorisations – Human Medicines’ in Version 7: Here’s what you need to know

HPRA Rolls Out Revised ‘Guide to Renewal of Marking Authorisations – Human Medicines’ in Version 7: Here’s what you need to know

by elena@investinu.ie | Mar 19, 2024 | Acorn Regulatory News

HPRA has updated their ‘Guide to Renewal of Marketing Authorisations-Human Medicines’ to Version 7 (AUT-G0025-7). Here is the link to click to read more:  HPRA guide Acorn Regulatory has summarised the key changes, which are listed below. This document has been given...
Italian Transition to EU Falsified Medicines Directive Compliance

Italian Transition to EU Falsified Medicines Directive Compliance

by elena@investinu.ie | Mar 7, 2024 | Acorn Regulatory News

The European Falsified Medicines Directive (EU-FMD) entered into force on 9th February 2019. However, Italy, Belgium, and Greece were granted a six-year exception because they already had mechanisms in place for validating and tracing pharmaceutical items. Italy has...
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