What Are The Common Mistakes With CEP’s?
The Certificate of Suitability or CEP is a certificate issued by the European Directorate for the Quality of Medicines (EDQM) that certifies the compliance of a pharmaceutical substance or active pharmaceutical ingredient (API) with the requirements of the relevant monograph...
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...
Virtual Wholesaling of Medicinal Products: 5 Things You Need To Know
What is virtual wholesaling? It is a topic that we get asked about time and again. So, we have produced a quick to read guide detailing 5 things that you need to know about the topic.
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...
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 NewsChristine McGrathHow-To & ExplainersPharmaceuticalRegulatory AffairsSubmissions
Repeat Use Procedure: What Are The Steps To Consider?
In this article, Christine McGrath, a senior member of our pharmaceutical regulatory affairs team, looks at the issue of Repeat Use Procedures. We explain what a Repeat Use Procedure is, the steps to take, and the pitfalls to avoid in...
Acorn Regulatory NewsEileen ShortissHow-To & ExplainersPharmaceuticalRegulatory AffairsRegulatory Strategy
Can Improvements Be Made To The Readability of Package Leaflets?
We look at the possible changes that could be made to package leaflets to improve their comprehension and readability.
Why More Companies Are Outsourcing Regulatory Affairs
The pharmaceutical and medical device sectors are facing unprecedented commercial pressures in every major healthcare market in the world. Issues such as increased competition, uncertainty regarding geopolitical issues such as Brexit and the individual nation’s drug pricing strategies have sent...
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...
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