COVID-19: Still on your Radar? Current vaccine approval status and what’s on the horizon

It is just over 2 years and 9 months since the WHO declared the COVID-19 outbreak a public health emergency of international concern. In the EU we now have a variety of options to protect us from COVID-19. There are as follows: Six vaccines are available for primary vaccination Notably, the three initial vaccines that […]

Nitrosamines: Step 3 Deadline Extension

The deadline for Step 3 (updating the marketing authorisation) for chemical medicines has been extended from 26 September 2022 to 1 October 2023. Step 2’s deadline (confirmatory testing) for chemical medicines remains as the 26th of September 2022 and MAHs should still submit their variations as soon as they conclude their investigations. The extension of […]

Revised ICH guideline Q3D on elemental impurities (EMA/CHMP/ICH/353369/2013)

A revised ICH Q3D guideline (R2) on ‘Elemental Impurities’ (EMA/CHMP/ICH/353369/2013) will come into effect on 24 September 2022. The guideline is revised: To amend permitted daily exposure (PDE) To amend monographs To add a section on limits for elemental impurities for cutaneous and transcutaneous formulations. The revised guideline is available on the EMA website. You […]

Nitrosamines Risk Assessment – Steps 2 and 3

MAHs are reminded that all activities related to Step 2 – Confirmatory Testing and related investigations in case of confirmed presence of nitrosamines should be performed sufficiently in advance to ensure that the necessary variation(s) can be submitted by the Step 3 deadlines, i.e. by  26 September 2022 for chemical medicines or 1 July 2023 […]

The new veterinary regulation (Regulation 2019/6) and its implications on regulatory submissions for veterinary medicinal products

The new veterinary regulation (NVR), Regulation 2019/6 applied to all EU Member States from 28 January 2022. The new legislation represents a significant change in how veterinary medicinal products are authorised, monitored and controlled in the EU. The Regulation was developed in order to implement a fit-for-purpose veterinary legislation which would no longer be based […]

When will DADI application forms replace the current eAFs?

The electronic application forms (eAFs) we are familiar with are in the process of being replaced later this year by a web based digital application form in a new eAF portal. The new eAF portal will look somewhat similar to the current IRIS portal. This project, known as DADI (Digital Application Dataset Integration), is intended […]

What are the regulators doing as Covid restrictions are being lifted?

International Regulators COVID-19 Omicron variant workshop International regulators participated in a ‘COVID-19 Omicron variant’ workshop. They discussed the effectiveness of current vaccines against the COVID-19 Omicron variant. They also considered regulatory requirements for possible future updates to vaccine compositions. The workshop took place on 12th January 2022 and was coordinated by the International Coalition of […]

AIFA – Remember to submit your list of pharmaceutical sales representatives for 2021

In accordance with comma 1 of art. 122 of Legislative Decree 219/2006 of Italian law it is a mandatory requirement to notify AIFA with a list of pharmaceutical sales representatives employed during the previous year. This includes the qualification and type of employment contract they have with the Pharmaceutical company. The deadline is fixed at […]

Merry Christmas and a Happy New Year from Ivowen

                  Another year draws to a close……… With so many of us working from home again this winter, due to the pandemic, Ivowen has decided to give charitable donations in lieu of gifts and a party this Christmas. As 2021 comes to a close we gives thanks […]

Are you ready for the Clinical Trials Information System (CTIS) implementation?

The Clinical Trials Information System is a harmonised and simplified end-to-end single entry point for clinical trials information in the European Union and in the European Economic Area and will go live on 31 January 2022. As a single entry point, it will be used for the submission, management and assessment of information throughout the […]

Still finding your feet with Remote Audits?

Here are Ivowen’s Remote Auditing Tips to help you get ready for that next audit Remote, off-site, paper-based, desk-top auditing call it what you want, what was once always put on the long finger is now becoming the norm for certain areas of auditing. Here are a few of our tips to help you prepare […]

Ivowen is hiring

Are you an experienced Regulatory Affairs professional looking for a new challenge in a dynamic and fast-moving consultancy?  Then we may be the fit for you. We are currently recruiting for Senior Regulatory Affairs Officers/Specialists (home-based) Role and Responsibilities Exciting opportunities exist for the right people in a dynamic and focused regulatory affairs consultancy company […]