2019 – What a year

Ivowen attended the Medicines for Europe conference in January (Regulatory and Pharmacovigilance), the annual EuDRAcon conference in May, exhibited at TOPRA in October and joined our clients from around the world at CPhI in November.

We all saw Brexit come and go, Twice !! We wait to see what lies in store for the next deadline in January 2020.

The FMD came into effect across Europe in February in most member states.

Bulgaria joined CESP, eCTD became mandatory for all human procedures, lots of new guidance was published (to keep us all on our toes) and Nitrosamines in medicinal products moved to the top of everyone’s agenda.

With the festive season now upon us and 2020 on the horizon, Ivowen are setting our sights on the year ahead.

We will be attending the Medicines for Europe conference in January 2020 (Regulatory and Pharmacovigilance) and we encourage you to contact us before mid-January with any specific questions you might like us to ‘ask the regulators’. This is a great opportunity to ask those difficult questions that you just could not get a straight answer to in 2019, on the ever present grey areas of Regulatory procedures.

To help you to plan ahead here are some helpful updates, in brief, as full articles will be posted in 2020:

Falsified Medicines Directive – Where we are now:

  • Implemented on 9th Feb 2019 in all MS except Greece, Italy and Belgium
  • The European Commission has produced a video to explain more about the safety features.
  • The HPRA have extended the use and learn period, initially to Sep 2019 and extended it again to end on a phased basis starting from 31st January 2020.
  • The MHRA is also taking a pragmatic, flexible approach to how they enforce the new legal requirements.



Ivowen are here to assist you in 2020 and will continue to provide the top quality service you have come to expect from us.

For more information on Ivowen’s services and how we can help you, contact us.

Written by Alice D’Alton.

Alice Dalton

CESP delivery system updated

The latest CESP system, version 2.0, was officially launched on October 1st 2015 (https://cespportal.hma.eu).

Ivowen has been using this facility regularly and can help to guide you through any aspects that you may be struggling with. There are a few new features which sets it apart from the old version:

  • The delivery file creation, has a new look and layout, with similar drop down menus but in a more user friendly format. The individual member states are now represented by the National Competent Authority logos, as well as their corresponding country flag.
  • The new dashboard feature is easy to find and provides you with real time statistics on what has been uploaded and subsequently delivered.
  • It incorporates a new tracking system which includes the following details:
  1. Delivery Created
  2. Delivery Completed
  3. Data Uploaded
  4. Data Delivered

You will still receive the e-mails confirming delivery, so you can file them.

  • There are also statistics presented in this space (in the form of bar charts) which provide an overview of your CESP activity in 2014 and 2015.
  • You can now also view delivery files which have been created but have not yet been utilised, and these delivery files can now also be re-downloaded but must not be re-used..
  • Furthermore, there is an Integrated delivery file system within CESP, which is very easy to use, but if you wish you can still work with your SFTP (e.g. FileZilla) as before.”

Please contact us if you would like any help with using CESP or have any other inquiries.

Written by Alice D’Alton

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