Applying for Marketing Authorisation via national route or DCP procedure in Ireland – HPRA slot booking

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 […]

UK Updates – Windsor Framework and Regulation (EU) 2023/1182 for Centralised Products

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 […]

UK updates to your Medicine – Windsor Framework and Regulation (EU) 2023/1182

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 […]

New Year…….New Registered Address

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 […]

Merry Christmas…….Everyone !!

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 […]

CEP 2.0 – A “new-look” CEP is here

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. […]

Back to Basics – Regulatory 101 – Legal basis of your MA application in the EU and UK

With our new logo and new website we expect some new visitors, so, I decided to go back to basics for those who may be new to Regulatory Affairs. (If you need help with the jargon visit our A-Z Glossary of Regulatory abbreviations) So, let’s start with the Legal Basis which forms the first step […]

CPHI 2023 – There and back again !

Well, I am fresh back from CPHI 2023, held in Barcelona this year and here are some of the highlights: This year was the busiest CPHI yet and the atmosphere on the show floor was vibrant. Over 52,000 passionate professionals from around the world gathered in the massive conference centre (Fira Gran Via) to connect […]

European Regulatory Affairs Limited

We have some exciting news to share – as many of you are aware the company’s name changed to ‘European Regulatory Affairs’ in 2020 and we have continued trading as ‘Ivowen’ to facilitate this transition. After many years as ‘Ivowen’ we are thrilled to announce that we are shedding our old moniker and stepping into […]