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
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...
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.
Strategy
Sign up for our newsletter today and stay informed on the latest regulatory updates and industry insights.