Acorn Regulatory NewsChristine McGrathHow-To & ExplainersMarketing Authorisation HoldersPharmaceuticalRegulatory Affairs
What Are The Common Variation Validation Issues? Find Out Here
Variations are a critical part of maintaining the lifecycle of all dossiers. A variation is any change to the currently approved content of a marketing authorisation which assists in ensuring continued compliance. We look at the main types of variations...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesGemma RobinsonHow-To & ExplainersPharmacovigilance
How Can Remote Audits Reduce Your Pharmacovigilance Costs?
Can remote audits really reduce costs for PV departments? The remote or desktop audit is growing in popularity as client companies assess costs and the environmental impact of traveling to an audit site. Furthermore, the restrictions on movement and travel...
Will The Updated CMC Guidelines Impact On Your Business?
Our overview will assist you in understanding the impact that the 2018 amendments will have on CMC guidelines. The updated CMC guidelines on the manufacture of the finished dosage form, CHMP/QWP/486/95, first issued in April 1996, were updated and the...
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...
Documented Information Procedures – What You Need To Know Ahead of The Deadline
ISO 9001:2015 Quality Management Systems – Requirements was published in September 2015 with a three-year transitional period. For organisations that have not yet upgraded to the revised standard, the ISO 9001:2008 certification expiry date will soon be approaching. Control of...
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.
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...
Using a US Dossier for a European MA Application? Here Is What You Need To Know
Over the years, we have worked with a significant number of US innovator companies and supported them in getting their ‘US developed medicinal product’ registered as a medicinal product in Europe. In this article, we look at some of the...
