Download Our Repeat Use Procedure Slide Deck
The issue of Repeat Use Procedures generates many questions to our pharmaceutical regulatory affairs team. We have created a slide deck looking at the main points to consider when completing a Repeat Sue Procedure. You can download it below.
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Watch The Northern Ireland Protocol Webinar
Acorn Regulatory hosted a webinar in association with TOPRA on March 4th, 2021 to look at the issue of the Northern Ireland Protocol from a consultancy standpoint. The webinar was a fully booked event and generated significant interest among regulatory...
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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.
How to Move from a DCP Close Out To Product Launch
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...
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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. ...
What You Need To Know About Drug Device Combination Products
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
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 document is...
The Competent Authorities Response to Covid-19
COVID-19 has transformed almost every aspect of our daily lives. Nevertheless, patient safety must remain a priority. COVID-19 may force MAHs and regulatory authorities to operate under business continuity mode, with possible impacts on the standard of work. Public health needs may...
Updated for 2020: Development of the Orphan Drug Sector
The orphan drug pipeline continues to grow and the sector has attracted considerable interest. We have updated this article for 2020 with updated statistics.
Download ‘Regulatory Intelligence 8’
Edition 8 of the Acorn Regulatory whitepaper series ‘Regulatory Intelligence’ is out now and can be downloaded from our site. This bumper edition looks at a wide range of sectors including: pharmacovigilance, CMC & pharmaceutical, and medical device. In Regulatory...
