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Acorn Regulatory Secures Manufacturer’s/Importer’s Authorisation Licence

Acorn Regulatory Secures Manufacturer’s/Importer’s Authorisation Licence

by elena@investinu.ie | Mar 1, 2021 | Acorn Regulatory News, Compliance, Quality Management System, Veterinary

Acorn Regulatory has obtained a Manufacturer’s / Importer’s Authorisation (MIA) licence  (otherwise known as an MIA Licence) for Batch Certification of Imported Medicinal Products for Veterinary Use. Our MIA licence enables us to partner with companies to...
How to Move from a DCP Close Out To Product Launch

How to Move from a DCP Close Out To Product Launch

by elena@investinu.ie | Sep 15, 2020 | Acorn Regulatory News

When a Decentralised Procedure (DCP) or a Mutually Recognised Product (MRP) process is drawing to a close, much of the emphasis is placed on getting a “positive opinion”. However, it is at a time like this, when submitting the final sequences that the focus on what...
How To Improve The Readability of Package Leaflets

How To Improve The Readability of Package Leaflets

by elena@investinu.ie | Jul 21, 2020 | Acorn Regulatory News, Compliance

What changes could be made to the readability of package leaflets to make them more accessible for patients? Eileen Shortiss, a Senior Regulatory Affairs Advisor at Acorn Regulatory is our in-house expert on all matters relating to package information leaflets.  She...
What You Need To Know About Drug Device Combination Products

What You Need To Know About Drug Device Combination Products

by elena@investinu.ie | Jun 8, 2020 | Acorn Regulatory News, Clinical & Medical

The European Medical Devices Regulation (MDR) 2017/745/EC was published on 5th May 2017 and has updated significantly the requirements for medical devices placed on the European market. It has introduced new requirements for manufacturers to comply with to achieve CE...
Expectations for Human Use Products During The Covid-19 Pandemic

Expectations for Human Use Products During The Covid-19 Pandemic

by elena@investinu.ie | May 12, 2020 | Acorn Regulatory News, Marketing Authorisation Holders, Pharmaceutical

The European Commission, the Coordination Group for Mutual recognition and Decentralised procedures – human (CMDh) and the European Medicines Agency have developed a ‘questions and answers’ document in light of the ongoing Covid-19 pandemic. The aim of the...
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