The Windsor Framework changed the regulation of medicinal products that were formerly in the scope of the EU centralised procedure so that these products are now licensed UK-wide under UK law. Products not within this scope are authorised UK-wide under UK and applicable EU law (as amended by Regulation (EU) 2023/1182 and Directive (EU) 2022/642), […]
The expected start date of the strongly recommended use of the PLM Portal web-based eAF for submissions to the National Competent Authorities for non-Centralised Procedure (CAP) variations is now planned for February 2025. Please note that the web-based eAF is already fully functional for the submission of variations for CAPs, including EMA-led worksharing variations […]
The Risk Management Plan (RMP) documents the risk management system considered necessary to identify, characterise and minimise a medicinal product’s important risks. The RMP should be updated throughout the life cycle of the product, for example; if there is a change in the list of the safety concerns when there is a significant change in […]
We continue our back to basics series for those who may be new to Regulatory Affairs (If you need help with the jargon visit our A-Z Glossary of Regulatory abbreviations). In the EU, there are two different procedures available to apply for a marketing authorisation application (MAA) for the same medicinal product in more than […]
With our new logo and new website we expect some new visitors, so, we are continuing our back to basics post for those who may be new to Regulatory Affairs. (If you need help with the jargon visit our A-Z Glossary of Regulatory abbreviations). MRP When an Applicant has a single marketing authorisation (MA) in […]
Here is the second installment of our Back to Basics series: VARIATIONS So, let’s start with a summary of the different types of variations & their timelines. Variations are changes made to the dossier of an authorised medicinal product after its initial registration They may concern administrative changes, Quality changes, Safety/Efficacy changes or Vigilance changes […]
The HPRA is now moving towards a system of slot allocation (expected submission dates) for new national product registration applications, in addition to the existing DCP slot requirement. Upon request, applicants will be given a submission slot in an agreed month. This will help capacity planning for timely assessment of applications and will help maintain […]
What it means for your company Batches of medicinal product, authorised through the centralised procedure (CAP), that are currently lawfully on the market in Northern Ireland may remain so until their Expiry Date However, these medicinal products cannot be moved from Northern Ireland to an EU/EEA Member State or be placed on the market in […]
Initially this is what you need to know: From the implementation of the Windsor Framework on 1 January 2025, the MHRA will regulate medicines across a UK-wide licensing regime. Most new Marketing Authorisation Applications (MAAs) will be granted as PL licences covering the whole of the UK. The MA number will have just a PL prefix […]
Welcome to 2024 everyone !!!!! Hopefully you managed to have a nice peaceful holiday season with minimal drama, lots of fun and laughter…… We wanted to let you know that with this new year we have a new address: Dungarvan Enterprise Centre, Lower Main Street, Dungarvan, Co. Waterford, X35 FX45, Ireland. You will have already […]
Before everyone breaks for the holiday season we want to wish all of our Clients, Suppliers and Friends a Peaceful and Relaxing Christmas. 2023 has been eventful (to say the least) and I am sure we are all looking forward to a nice break. ERA office will be closed from Friday 22nd December until Tuesday […]
The European Directorate for the Quality of Medicines & HealthCare (EDQM) are currently implementing a “new-look” CEP (Certificate of Suitability). This is following a public consultation with stakeholders which in turn led to the launch of the project CEP 2.0. The aim of the project was to provide greater transparency and reduce the regulatory burden. […]
Dungarvan Enterprise Centre,
Old Friary Building,
Lower Main Street, Dungarvan,
Co. Waterford, X35 FX45,
Ireland.