How To Prepare for Remote Audits
Current restrictions on travel, brought about by Covid-19, have resulted in the increase in remote audits being carried out by health authorities. While there might not be an auditor sitting across a meeting room table from you, there are still...
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Acorn Regulatory Secures Manufacturer’s/Importer’s Authorisation Licence
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.
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How To Improve The Readability of Package Leaflets
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. ...
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‘Selected Writing from Acorn Regulatory’ Download It Here
‘Selected Writing from Acorn Regulatory’ highlights just some of the most read articles written by our expert staff in the past 12 months. This e-book is packed with regulatory and pharmacovigilance insights from the team at Acorn Regulatory. Download it...
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What Are The Benefits Of Smart Packaging In The Pharma Sector?
Much has been written about the benefits of smart packaging for the pharmaceutical sector. The introduction of smart packaging technologies is regarded as another step in safeguarding the security of medicinal products and devices. Below, we look at smart packaging...
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Pharmaceutical Code of Practice – Are You Aware of Your Responsibilities?
Acorn Regulatory assists companies in maintaining compliance with a variety of codes of conduct. In this article, we look at the issues surrounding the code of practice that governs pharmaceutical companies in the UK and Ireland. The respective IPHA and...
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Advertising of Medicinal Products – An Overview
Advertising of medicinal products in Ireland is governed by a statutory instrument (S.I.) 541/2007, which transposes into Irish law Titles VIII and VIIIa of Directive 2001/83/EC (as amended by Directive 2004/27/EC). We look at the issues relating to advertising a...
MHRA Moving Towards Paperless Communications
Following discussions with industry bodies, the MHRA is now replacing all paper-based communications with emails. The emails will replace paper-based communications about Common European Submissions Portal (CESP) submissions. Companies working with the MHRA will now receive emails to a single address...
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EU Medical Device Vigilance Reporting: Part 2 – Frequently Asked Questions
In part 1 of this series we gave you a quick overview of the medical device vigilance reporting requirements for IVD and medical device manufacturers. In this article, we are going to delve a bit deeper and answer some questions about vigilance...
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EU Medical Device Vigilance Reporting – Part 1 – ‘The Abridged Guide’
If you are a manufacturer of an IVD or a medical device, once your product is on the market, you must have an effective system for reviewing and evaluating customer complaints and product issues for any safety concerns. The European...
