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.
The document is intended to give practical guidance on the applicable rules to centrally authorised medicinal products for human use intended to be placed on the market in Northern Ireland before and after the application of Regulation (EU) 2023/1182.
See here for ‘Questions and Answers’ document and here for ‘Legal Content’ link
Read More
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...
Strategy
Sign up for our newsletter today and stay informed on the latest regulatory updates and industry insights.