Applications To Host European Medicines Agency Must Be Submitted by July 31st
Reports in this morning’s Financial Times (23/05/17) state that applications to host the European Medicines Agency will have to be submitted by July 31st and that a decision on the future location of the agency will be known by the...
Brexit – Moving A Marketing Authorisation
The UK’s decision to leave the EU will cause considerable upheaval for holders of marketing authorisations. As the recognised Brexit experts in the regulatory affairs sector we have some advice and a number of articles to help companies that are...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesHow-To & ExplainersMarketing Authorisation HoldersPharmaceuticalQuality Management SystemRegulatory Affairs
5 Steps To Obtain A Wholesale Distribution Authorisation Licence
The WDA process is complex. Indeed, many companies turn to us to manage the application process on their behalf. Here, we have highlighted 5 steps that companies must undertake if they want to secure a Wholesale Distribution Authorisation licence.
SWOT Analysis of the Bonn Bid for the European Medicines Agency
Bonn, once a city that played a significant role in late 20th century world affairs, has not featured in news reports as frequently in recent years having been shorn of the German parliament in 1990. The city is now one...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersPharmaceuticalPharmacovigilance
Simplified Adverse Event Reporting in Europe – Are You Prepared for the Switch Over?
Since the introduction of the pharmacovigilance legislation in 2010, a commitment to a simplified approach to adverse event reporting was introduced by the EMA (Articles 107(3) and 107a(4) of Directive 2001/83/EC). This approach would only apply however following an independent...
SWOT Analysis of the Barcelona Bid for the European Medicines Agency
As inducements go, few are as tempting as the Torre Agbar in Barcelona. The iconic Catalan skyscraper has been offered to the European Medicines Agency should they wish to choose Barcelona as their next home. Until recently, the Spanish city...
SWOT Analysis of the Copenhagen Bid for the European Medicines Agency
Copenhagen is a significant contender to host the European Medicines Agency. In this blog post we look at Copenhagen and carry out a brief SWOT analysis of its capacity to host the EMA.
Blog: What Is The MHRA Quiet Period?
In this blog Brian Cleary answers the questions that many people are asking; what is the MHRA quiet period and why does it exist?
Regulatory Affairs Case Study – Moving to OTC
Every day we work with some of the world’s biggest and most dynamic healthcare companies in the pharmaceutical and medical device sectors. Our team has a well deserved reputation for service excellence and their ability to successfully manage the most...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesBrexitEU Authorised RepresentativeIVD DevicesMDD DevicesMedical Devices
10 Responsibilities of a EU Authorised Representative
The responsibilities and role of the EU Authorised Representative (or EUAR) is now in the spotlight as a result of the UK’s decision to leave the EU. Many companies have previously chosen EU Authorised Representatives from the UK and, as...
