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The current Variations Regulation, i.e. Commission Regulation (EC) No.1234/2008, was introduced in 2008 with the aim to simplify and introduce more flexibility to the process of post-approval changes to marketing authorisations (MA). A successful variations system...
Revision 2 of ICH Q5A Guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin comes into effect Virus contamination is a major concern for the manufacture of biotechnology products. While products derived from...
The ICH Q2 Guideline on the validation of analytical procedures applies to the analytical procedures used for release and stability testing of commercial drug substances and products. ICH Q2 has been in existence since 1993, with ICH Q2(R1) coming into effect in...
9th February 2025 is the deadline for full implementation of the EU Falsified Medicines legislation (Directive 2011/62/EU and EU Delegated Regulation 2016/161) at a national level in Italy. The law outlining the steps towards the Italian national implementation of the...
We are thrilled that our Regulatory Team was shortlisted for a Pharma Industry Awards -Pharma Contract Services Company of the Year 2024. Our nomination is for their excellent work on implementing a client Regulatory Information Management (RIM) System.
Our Head of PV is attending the World Drug Safety Congress during 9-10th October in Amsterdam this year. This is Europe's Most Exciting Drug Safety and PV event and with over 90+ exhibitors, 300+ speakers and 1,500 PV experts in attendance, it promises to be a truly...
On Oct 8-10th CPhI Milan 2024 will open its doors to over 60, 000 people. This year, our founder and CEO; Gemma Robinson and Senior Project Manager; Janet Fitzgerald will be in attendance. Pharma professionals from all around the world will converge in Milan for the...
From our experience, companies are falling short of their pharmacovigilance obligations with regards to strategic, tactical and operational level PV audit planning. This can lead to areas of non-compliance, risks to patient safety and inspection findings. Outlined...
More than 4 years after the United Kingdom’s exit from the EU in January 2020, the industry is still dealing with the impact of Brexit and the Northern Ireland Protocol. Most recently being the implementation of the Windsor Framework.
We were delighted to attend the 1st ever BioPharmaChem Impact 24 Conference which took place yesterday May 23rd in the beautiful surroundings of Fota Island Resort, Cork.
Guidelines on the Environmental Risk Assessment (ERA) of Medicinal Products for human use EMEA/CHMP/SWP/4447/00 Rev.1 issued on the 15th February 2024 replaces EMEA/CHMP/SWP/4447/00 Corr 2 which has been in effect since 2006.
HPRA has updated their ‘Guide to Renewal of Marketing Authorisations-Human Medicines’ to Version 7 (AUT-G0025-7) and Acorn Regulatory has summarised the key changes.
Discover the Italian Transition to EU Falsified Medicines Directive Compliance and rising questions about its impact on the Bollino System.
Discover the challenges and advantages of outsourcing various pharmaceutical services to multiple providers versus a single service provider. From managing the product lifecycle to ensuring regulatory compliance and communication between teams, find out how a cohesive approach can streamline processes and reduce costs. At Acorn Regulatory, we prioritise your product’s success with our global expertise and commitment to excellence.
The EMA has issued Questions and Answers to Stakeholders on the implications of Regulation (EU) 2023/1182 for centrally authorised medicinal products for human use.
We published Part 1 of our report on the Global DIA Forum for Qualified Persons in December 2023. If you missed it, catch up here.
The FDA has provided a document attached to support product reformulation for products that contain Carbomer manufactured with Benzene.
Get up-to-date information about the Northern Ireland MHRA Authorised Route (NIMAR). Check out the recent MHRA Windsor Framework-aligned guidance changes to ensure the legal supply of POMs in the UK and EU. Discover how the Windsor framework will allow ‘PL GB’ packs to be sold in Northern Ireland in January 2025.
Warning: Falsified units of Ozempic pens found at wholesaling sites in UK and Europe, identified while scanning packs as part of FMD checks.
“MHRA updates guidance for UK medicinal product labeling and packaging. Effective January 1, 2025:EU/UK joint packs not allowed in the supply chain.Medicines in the UK (including Northern Ireland) to be authorized separately by MHRA.EU Falsified Medicines Directive no longer applies; ‘UK only’ labeling required.MAHs must submit ‘UK only’ statement by December 31, 2024, with a 6-month over-sticker transition until June 30, 2025. Brought to you by Acorn Regulatory.”
Stay Informed with HPRA’s Latest Guidance Updates – AUT-G0035-23 Revision | Medicinal Product Labeling Changes Simplified | Regulatory Compliance Made Easier | Get the Latest Submission Requirements”
Choosing the right Reference Member State (RMS) for your EU procedure can be difficult, Here is some advice to consider, helping you make the choice for your company.
Acorn Regulatory has worked with a number of MAHs including ‘virtual MAH’s’ to help them understand their responsibilities and develop a QMS suitable for their needs and to support them with each of these responsibilities. MA Holding entities are subject to Market Compliance Inspections by any Health Authority, in any EU country where they hold an MA. The HPRA carry out multiple MAH Market compliance inspections each year.
We answer some of the most frequently asked questions that we recieve from clients regarding EU Medical Device Vigilance Reporting in this article.
MDR 2017/745 has greatly expanded the responsibilities of importers and distributors. This article highlights the key responsibilities for both.
In this article, we have provided the fundamentals for you to navigate through the EU Medical Device Vigilance Reporting system. Click to read more.
We have revised our MDR essential guide for 2020 to provide a fresh outlook on the developments of MDR in 2021. Click to read more here.
This article looks at the increase in requirements under MDR and provides a revised summary on Conformity Assessment Routes. Read more.
We provide a new perspective on the specific requirements of Post Market Surveillance (PMS) following the introduction of MDR in 2021. Read more here.
This revised article concentrates on the role of the Person Responsible for Regulatory Compliance (PRRC). The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European Medical Devices legislation that a person is...
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