ICH Elemental impurities

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

Elemental impurities guideline What is it… The ICH has introduced this new guideline to control the elemental impurities that may be present in drug products. It replaces EMEA guidance on Specification limits for residues of metal catalysts or metal reagents (EMEA/CHMP/SWP/4446/2000). This guideline applies to new drug products (with a new drug substance) and to […]

New ATC codes for 2017

The Anatomical Therapeutic Chemical (ATC) Classification is an internationally accepted classification system for medicines.  This system is maintained by the World Health Organisation (WHO).  The WHO assigns ATC codes to all drug substances based on their therapeutic indication. The assigned ATC code must be present in your product information. What does this mean for you? […]

Ivowen attends EudraVigilance Training Course on Reporting of ICSRs/SUSARs in the EEA – Suspected Adverse Reactions to Medicines

What is EudraVigilance? EudraVigilance (http://eudravigilance.ema.europa.eu) is a centralised European database of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA) and supports the safe and effective use of medicines (Figure 1 – EudraVigilance System Components).  Adverse reactions (ADRs) can be reported during the development […]

Onwards and upwards at Ivowen

I am delighted to announce the promotion of Alice D’Alton to the role of Regulatory Affairs and Business Manager. Alice has been an integral part of the team here in Ivowen for over three years and has more than 10 years experience working in the pharmaceutical industry. This new role within Ivowen will facilitate the […]

What do I do??

In my circle of friends I feel like I am the “Chandler Bing” and it’s not because I am the funny one; no, it’s because no one knows or understands what I do for a living. My mother still believes I work in a laboratory and have a working knowledge of all medicines and once […]

HPRA Safety Features Workshop – update

Ivowen recently attended the HPRA Safety Features Workshop Athlone (3rd May 2016).  The following is a summary of the key take-home points from this workshop. Introduction of a Unique Identifier (UI) and Anti-tampering Device (ATD) on Packaging of POM and Certain OTC Medicines Certain aspects of the implementation of the Falsified Medicines Directive (Directive 2011/62/EU) […]

Where will we be in 2016?

We are already in Quarter 2 of 2016 and as it comes to the end of April we thought it necessary to update current and potential clients as to where we will be and where you can meet us in 2016. As a company providing expert advice and support to our clients we at Ivowen […]

Falsified Medical Directive (FMD) and updated QRD template released February 2016

Falsified medicines are fake medicines that are designed to mimic real medicines. Due to the increase of falsified medicines on the market the EU has a strong legal framework for licensing, manufacturing and distribution of medicines. In July 2011 DIRECTIVE 2011/62/EU (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0074:0087:EN:PDF ) came into force; this directive aims to prevent falsified medicines entering the […]

Points to note on the eAF

General The eAF is mandatory for all procedures from 01/01/2016 (CP, MR, DC, National in eCTD/NeeS/Paper). However, Presubmission Meeting Requests, Article 61(3) & MAT forms remain the outside scope and can be submitted as paper or PDFs. Please contact us if you require any assistance with any of the forms or any advice on any […]