Analysis of the Milan Bid To Host The EMA
We first wrote about Milan as a possible home for the European Medicines Agency approximately 12 months ago. The Italian city was ‘quickest out of the blocks’ in staking its claim to host the European Medicines Agency. It’s charismatic...
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Type I Variation: Apparently Not So Simple
In response to queries from regulatory professionals, we asked one of our regulatory experts to provide an overview of a Type I variation. In this article, we look at the common validation issues, what to look for in relation to...
Acorn Regulatory Shortlisted for County Tipperary Business Award
We have been shortlisted for an award in the inaugural County Tipperary Business Awards in the Best SME Category.
Acorn Regulatory Takes Part in Grant Thornton Docklands 5K
2 teams from Acorn Regulatory took part in last night’s Grant Thornton 5K challenge in the Dublin Docklands.
eCTD Baseline Submissions
In this article we look at eCTD Baseline Submissions and the issues relating to the January 1st 2018 deadline.
Product Information Text: Formats Suitable For Blind & Partially Sighted
Braille is an internationally recognised reading and writing system used by blind and partially sighted people. The braille alphabet consists of various arrangements of raised dots that make up each character. In accordance with European legislation, braille is required to...
What The Newspapers Are Saying About The EMA Issue
The applications from potential host countries have been received and the ‘horse trading’ has begun. The decision on the EMA issue will be made by November. There is stiff competition from competing cities and many have made significant offers in...
Blog: The Brexit Transition Period & The Life Sciences Sector
In this blog, Brian Cleary looks at the comments of British Chancellor Philip Hammond regarding the Brexit Transition Period.
The Tick-Tock of the EMA Clock
July 31st marks the final date for submission of proposals by member states to host the European Medicines Agency. Last month, at the EU summit in Brussels, the European Council endorsed a procedure to determine the final location of the...
Are You Ready for the Falsified Medicines Directive?
The Falsified Medicines Directive (FMD) was published in 2011 with the aim of preventing falsified medicines from entering the pharmaceutical supply chain in the European Economic Area. Conformity with the FMD will be required from February 9th, 2019 next.
