Filing Services – Decentralised Procedures
Leading pharmaceutical company uses elc group to achieve marketing authorisation for a new cardiac treatment in multiple EU states
Using elc group to undertake a complex Decentralised Procedure submission to bring a new generic medicine to market in 20 European countries ensured the entire process was completed in a timely, coordinated and highly effective manner.
The Challenge
Achieve identical marketing authorisations for a new generic cardiac treatment in 20 EU countries simultaneously
Undertaking a Decentralised Procedure (DCP) of this scale would deliver a strong commercial advantage – receiving identical marketing authorisations for its medicinal product in all chosen Member States simultaneously would reduce launch costs and create a strong brand presence for the product in the EU from day one.
However, the time and effort burden involved in compiling the necessary documentation alone was further complicated by the fact that separate applications were required for each of the drug’s delivery formats.
Furthermore, the entire process needed to be closely coordinated, from the initial submission to the chosen Reference Member State (RMS) to the effective and fast management of any potential concerns raised by the 19 other Member States in the simultaneous approval process. To this end it was essential that a dedicated focus was maintained on ensuring each individual licensing strand was enabled, and any issues were managed expertly, and on time.
The company turned to elc group to provide the expertise, resource and ongoing management of the entire DCP process from start to finish.
The Solution
Divesting the DCP to elc group delivered the expertise and resource needed to ensure the entire procedure was appropriately managed to completion
Using elc group gave the company immediate access to all the resources it needed to manage every aspect of this highly complex and application. With a wealth of experience in preparing and submitting dossiers using the DCP system, elc group was able to provide insight, advice and guidance every step of the way, ensuring the entire DCP process proceeded to simultaneous completion.
Following a detailed review of the therapeutic area and an evaluation of the potential costs relating to the lead procedure, elc group was able to make a powerful recommendation on which country should become the Reference Member State (RMS) for the DCP.
Next, elc group prepared a detailed regulatory strategy, taking into consideration patent expiry dates, data exclusivity dates, packaging requirements, and the summary of product characteristics (SmPCs) for each member state considering the RMS product assessment report.
Alongside preparing the initial submission to the RMS, elc group took control of drafting all documentation relating to the procedure and the coordination of all applications across the other 19 target member states. Within just four days, elc group completed the DCP submission of all documentation, liaising in total with 23 European agencies.
With specialist representatives in each of the countries involved, elc group was able to ensure local liaison with all regulatory bodies was maintained at all times, responding quickly to ensure any potential delay was minimised. And with elc group managing the entire process, document translation and administration (in 20 languages) was managed in a timely manner and as an integral part of the procedure.
The Result
The elc group solution delivered measurable cost savings, ensuring the submission and coordination of the DCP was maintained in a seamless manner. From identifying the most appropriate RMS to undertake the initial product assessment to ensuring all parallel license submissions were managed and coordinated, elc group was able to ensure the company achieved its goal of the concurrent issue of 80 licenses for its products.
The benefits of a fully managed DCP application service from elc group include:
- Releases the in-house regulatory team from the administrative burden of managing large and complex marketing authorisation applications in two or more EU states
- Resources to support multiple applications in the Reference Member State (RMS) and Concerned Member States (CMS)
- A dedicated team to focus on working in a positive and collaborative manner with the Reference Member State (RMS)
- Expertise at identifying the most appropriate RMS for the medicinal product
- Defining a regulatory strategy that minimises any risk of costly delay
- Comprehensive expertise at completing all documentation in local languages, and access to local country experts to manage relationships in each Concerned Member State (CMS)
- Certainty that resources can be ramped up and down at key points of the DCP process
- Detailed guidance on all requirements needed to satisfy regulatory bodies with regard to marketing authorisations in two or more Member States