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Rising Summer Temperatures: Protecting Pharmaceutical Warehouses Through GDP Compliance.
As summer temperatures continue to rise, warehouses storing pharmaceutical and medicinal products are under increasing pressure to maintain strict environmental standards. Under EU Good Distribution Practice (GDP) guidelines, temperature-sensitive medicines must be...
Artificial Intelligence in Pharmacovigilance (CIOMS WG XIV)
Purpose This briefing highlights the key implications of the CIOMS Working Group XIV report on Artificial Intelligence in Pharmacovigilance (PV) published in December 2025[1] and outlines considerations for organisations deploying AI in safety surveillance. Strategic...
Meet Christine McGrath – Regulatory Affairs Manager at Acorn Regulatory
At Acorn Regulatory, we’re proud to share the stories of the people who make our company what it is. In this edition, our Founder and Managing Director, Dr Gemma Robinson, sits down with her colleague and friend, Christine McGrath, to discuss Christine’s career...
Importation of Exempt Medicinal Products in Ireland
Exempt Medicinal Products, commonly known as “EMPs,” are provided “in response to a bona fide unsolicited order, formulated in accordance with the specifications of a practitioner for use by his individual patients on his direct personal responsibility, in order to...
Performing a warehouse audit according to Good Distribution Practice (GDP)
Performing a warehouse audit according to Good Distribution Practice (GDP) standards involves evaluating the facility's compliance with regulations that ensure the quality, safety, traceability, and integrity of pharmaceutical products throughout storage and...
Updated HPRA Guide to Wholesaling and Brokering of Medicinal Products for Human Use in Ireland
Did you know that the HPRA updated their Guide to Wholesaling and Brokering of Medicinal Products for Human Use in Ireland (IA-G0008-8) last week? This is a key document for all wholesalers and brokers in Ireland to be aware of. The main updates are to the reflect...
MHRA List of Category 2 Products – what UK QPPVs need to know.
The MHRA maintains a published list of all approved UK products classified as category 1 and category 2 under the new rules following the implementation of the Windsor Framework. The Windsor Framework, effective since 1st January 2025, changed the regulation of...
EMA Issues a common masking policy for ICSRs submitted to EudraVigilance
Last month, the EMA issued a common masking policy. This document was delivered as an outcome of an EV audit performed by the European Data Protection Supervisor (EDPS), that should be complied with by all entities reporting to EudraVigilance (including MAHs). The...
MA Holder Actions for IDMP & PMS Implementation
The EMAs phased implementation of IDMP is well underway, with key milestones approaching in Q3 2025. Data enrichment is already available for all products through the Product User Interface, XEVMPD. Soon the API will be live to connect your RIM systems to carry out...
Market Compliance for Virtual MA Holders
The HPRA have been active in inspecting MA Holders in Ireland for over 15 years, carrying out 3-5 Market Compliance Inspections a year. These inspections are distinct from GMP, GDP or PV audits and can encompass all Regulatory, Quality and Pharmacovigilance...
The Pharma Package
The European Council issued a press release on 4th June 2025 confirming they are now ready to begin negotiations with the European Parliament, having agreed its position on ‘The Pharma Package’. The new rules aim to make the EU’s pharmaceutical sector fairer and more...
Update to IPHA Code of Practice v8.6
The IPHA issued an update to their Code of Practice for the Pharmaceutical Industry in March 2025, replacing version 8.5, which has been in place since 1 March 2021. The updated version 8.6 will come into effect on 1 June 2025. The updates bring the Code in line with...
EC proposes downgrading of variation classification for quality changes
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 Guideline on viral safety evaluation ICH Q5A
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...
New ICH Q2(R2) and ICH Q14 Analytical Procedure Guidelines released
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...
Italian Transition to EU Falsified Medicines Directive Compliance – Update
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...
Shortlisted for a Pharma Industry Award
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.
World Drug Safety Congress, Europe
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...
CPHI Milan 2024
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...
PV Audit Strategy and Risk Assessment
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...
Brexit Revisited – Are you prepared for the Windsor Framework?
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.
BioPharmaChem Impact 24 Conference
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.
New Guidelines for Environmental Risk Assessment of Medicinal Products: What You Need to Know
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 Rolls Out Revised ‘Guide to Renewal of Marking Authorisations – Human Medicines’ in Version 7: Here’s what you need to know
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.
Italian Transition to EU Falsified Medicines Directive Compliance
Discover the Italian Transition to EU Falsified Medicines Directive Compliance and rising questions about its impact on the Bollino System.
Why its better to trust Acorn Regulatory to manage your entire product lifecycle?
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.
EMA Addresses Stakeholder Queries
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.
Global DIA Forum for Qualified Persons for PV (Part 1)
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.
FDA Urges Carbomer Reformulation
The FDA has provided a document attached to support product reformulation for products that contain Carbomer manufactured with Benzene.
MHRA Updated NIMAR Guidance to reflect Windsor Framework
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.
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