Update on the new Veterinary Medicines Regulation (Regulation (EU) 2019/6)
The new veterinary medicines regulation (Regulation (EU) 2019/6) will come into force in January 2022. It will modernise the existing rules on the authorisation and use of veterinary medicines in the European Union. The new regulation seeks to simplify the...
How Unique Device Identifiers Will Work Under MDR
The Unique Device Identifiers system under the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 IVDR applies new requirements on all participants of the supply chain with the final aim to improve patient safety through better traceability and transparency. Both...
Acorn Regulatory NewsBrexitChristine McGrathClinical & MedicalDanica CvetkovicGemma RobinsonMarie CarrollMarketing Authorisation HoldersPharmacovigilancePublicationsRegulatory Strategy
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‘Regulatory Intelligence 6’ from Acorn Regulatory looks at the latest trends and issues in the sector. You can download your edition of the e-book by completing the form below.
Acorn Regulatory NewsChristine McGrathHow-To & ExplainersMarketing Authorisation HoldersRegulatory Strategy
What MAH’s Need to Know About Outsourcing
The continued growth of outsourcing of manufacturing in the pharmaceutical industry and the use of more complicated supply chains means that in certain situations the Marketing Authorisation Holder (MAH) can become very far removed from manufacturing process and products. However,...
Acorn Regulatory NewsGemma RobinsonHow-To & ExplainersMarketing Authorisation HoldersPharmaceuticalRegulatory AffairsRegulatory Strategy
Can You Use A U.S. Dossier To Apply For A European Marketing Authorisation?
Is it possible to use a U.S. dossier when applying for an E.U. marketing authorisation? This is a question that is asked time and again. We first published this article in 2017. We have updated it and included links to...
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...
Scientific Advice Meetings – Advice for Companies
Scientific Advice Meetings are an area where clients and prospective clients consistently seek our support. Our expert team has significant experience of dealing with relevant agencies for such meetings. This article looks at a number of issues related to the...
EU MDR: What Will The Impact Be For Economic Operators?
Two new EU Regulations entered into force on 26th May 2017. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostics (IVDR) replace the current three Directives, which have been in place since the early 1990s....
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...
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