2018’s Most Read Pharmaceutical Articles from Acorn Regulatory
In our end of year series we are looking at the most widely read articles on our website. This week we are looking at the most read pharmaceutical articles written by our pharmaceutical specialists. They cover a variety of areas...
Pharmaceutical Development for Historic Dossiers: An Overview
Getting historic dossiers registered in new markets can have its difficulties, especially when the dossier might have been developed before the development of current guidance and requirements. One such difficulty is the concept of Pharmaceutical Development and Quality by Design...
RMS In the UK? Here Is What You Need To Do
Reference Member States (RMS) have rarely been changed, as there has been no need to do so. Brexit has changed all of that and now many companies are having to change their RMS because of the UK’s decision to leave...
Acorn Regulatory NewsBrexitIndustry NewsMarie CarrollMarketing Authorisation HoldersPharmaceuticalPharmacovigilance
Centralised Procedure Medicinal Products: Brexit Update
How will the UK’s departure from the EU impact on medicinal products for human and veterinary health? We have written an overview that, we hope, will serve as a handy guide. The Q & A document “Questions and Answers to...
Acorn Regulatory NewsEileen ShortissMarketing Authorisation HoldersPharmaceuticalRegulatory AffairsRegulatory Strategy
Package Information Leaflets: An Overview
Acorn Regulatory’s consultants are package information leaflet experts. We have a team dedicated to the creation and testing of package information leaflets. Members of our team have written extensively on this website and in other industry publications about the issues...
Acorn Regulatory NewsBrexitMarie CarrollMarketing Authorisation HoldersPharmaceuticalRegulatory Strategy
Focus on Variations
Acorn Regulatory’s pharmaceutical regulatory affairs consultants are experts in the sector. Every day our team members are working on behalf of clients to ensure that their variations are completed in as timely a manner as possible. Members of our team...
Marketing Authorisation Holders – An Overview
Acorn Regulatory’s consultants are experts in the sector. Members of our pharmaceutical regulatory affairs team have written extensively on this website and in other industry publications about the issues associated with marketing authorisation holders and much more. Below, we...
Orphan Drugs: 10 Facts You Need To Know
Much has been written about orphan drugs in recent times. These products, developed specifically to treat a rare disease, have become more common in the marketplace. At the time of writing (May 2018) there are almost 300 orphan drugs commercially...
The Worksharing Procedure for Variations for National Marketing Authorisations in the EU
Did you know that Article 20 of Commission Regulation, known as the ‘Variations Regulation, allows for a Marketing Authorisation Holder to submit the same Type IB or Type II variation, or the same group of variations affecting more than one...
Acorn Regulatory NewsGemma RobinsonHow-To & ExplainersMarketing Authorisation HoldersPharmaceuticalRegulatory AffairsRegulatory Strategy
Is Well Established Use Going Out of Fashion?
The choice of legal basis is one of the most crucial choices that a Marketing Authorisation Holder must make. One of the choices available, ‘well established use’ seems to waning in popularity as a choice amongst MAH’s. Here, we look...
