Ivowen - Pharmacovigilance

How to get an Assessor’s opinion before you contact the Competent Authorities

Firstly, in this very unusual time for us all I want to let you know that our dedicated team are all healthy, safe and working from home, business as usual, to ensure that we continue to provide you with the high quality and efficient service you have come to expect from Ivowen.

Have you ever wished you could get the opinion of an Assessor before you go to the National Competent Authorities with your queries? 

Well, I am delighted to introduce you to to our newest team member Claire Brown.

Claire has come directly to Ivowen from the Health Products Regulatory Authority (HPRA) and brings with her a wealth of experience as a pharmaceutical assessor of human medicinal products. Claire has been part of the team here in Ivowen since 2019 and has more than 12 years experience working in the HPRA. She started there as a Scientific Officer working mostly on veterinary medicinal products and was promoted to Pharmaceutical Assessor after 3 years.

Claire completed her undergraduate work in Chemistry and her postgraduate work in Neuropharmacology and Industrial Pharmaceutical Science.

Claire adds her extensive experience to our knowledgeable team so that we can enhance the services we provide to you and continue to give you an ‘Assessor’s eye’ opinion on your applications before you submit them.

I invite you to visit our updated Meet the Team page to see all the talented people who enable us to guide you through all aspects of regulatory strategy, dossier preparation, MA submissions through to national phase, post-approval variations, product development, quality overviews, medical devices and much much more.

If you could use some assistance to navigate the complex world of regulatory, please feel free to contact us for further information.

Written by Alice D’Alton.

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.

Nitrosamines

 

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.

News from the HPRA

The HPRA are always striving to improve their processes and ways of working.  The following updates in the Human Medicines Department should help us all in our dealings with each other.

New electronic workflow system

The human medicines department within the HPRA have transitioned to using a new (internal) electronic workflow system. Due to this the following changes are worth noting for MA (marketing authorisation) applications and the issuing of licences and summary of product characteristics (SmPCs) by the HPRA:

  • Product Specific Details (PSD)

The product specific information (which included the product composition and the manufacturers’ details) will no longer form part of the product licence document that is issued by the HPRA.
Previously the product licence document consisted of the licence cover page, PSD and Summary of Product Characteristics (SmPC). In future, the product licence document will consist of the licence cover page and the SmPC only. The information previously detailed in the PSD will be logged on the HPRA database and remain a registered part of the product marketing authorisation.

  • Summary of Product Characteristics (SmPC)

Updated SmPCs and Package Leaflets will publish on the website 24 hours after case closure.
(For details relating to the font/format of SmPC documents, further details are found in HPRA newsletter number 62).

  • PA numbers 

PA, or Product Authorisation numbers, are the Irish version of the MA number.  Newly allocated PA numbers for new holders will now contain 5 digit prefix.

  • Case Reference Number (CRN)

Previously CRNs were displayed as seven digits. These will now be alpha numerical for any new cases e.g. CRN00011X. The HPRA will still be able to identify any closed or ongoing cases using the old CRN.

  • Digital communications

All cases on the new system will be assigned a dedicated e-mail address e.g. [CaseNumber]@case.hpra.ie. This will enable you to send the HPRA case specific communications directly to the case and the allocated team. E-mail correspondence sent to you from the HPRA that is relevant to the case will come from this dedicated e-mail address. The European e-mail boxes will still be used where applicable.  You should consult with your IT department to ensure that e-mails of this nature are not blocked in your organisation.

 

National Scientific Advice Guide

The HPRA have recently updated their National Scientific Advice Guidance (which commenced in 2017) to include additional therapeutic areas for stakeholders. These areas include: anti-infective products, vaccines, disorders of haemostasis and thrombosis, cardiovascular diseases, common allergic conditions, advanced therapies in certain clinical indications and biostatistics. The updated guidance can be found at the following link:

(Guide for national scientific advice)

 

Written by:

Claire Brown