Can You Use A U.S. Dossier To Apply For A European Marketing Authorisation?

Is it possible to use a U.S. dossier when applying for an E.U. marketing authorisation?  This is a question that is asked time and again.  We first published this article in 2017.  We have updated it and included links to other relevant articles that will assist companies in dealing with this issue.

Over the years, we have worked with a significant number of US innovator companies and supported them in getting their ‘US developed medicinal product’ registered as a medicinal product in Europe. In this article, we look at some of the issues we have encountered in taking a US-developed dossier for a new marketing authorisation application in Europe on behalf of a client.

Using A U.S. Dossier for a European MA Application

A Common Pitfall

A carefully planned regulatory strategy is critical to the success in obtaining a marketing authorisation / approval letter for a medicinal product in any part of the world. Occasionally, the regulatory strategy has not been carefully planned and the EU requirements for bioequivalence or clinical trials have not been followed.  This can be particularly problematic for innovator companies who have developed a novel pharmaceutical form or formulation while using a known or established active pharmaceutical ingredient for a single market  (the US for instance) or region and now want to expand their reach and take it to.  The selection of the appropriate ‘legal basis’ for the medicinal product application can cause considerable anguish and consternation to intending Marketing Authorisation Holders (MAH’s) as they try to understand why European Health Authorities (HA’s) have very different opinions and interpretation of the definition of the legal basis for ‘well established use’.   We wrote about this issue in 2017 in ‘How do you translate your non-EU dossier  for the EU market’ .

The Importance of a Scientific Advice Meeting

We would highly recommend obtaining Scientific Advice Meetings either face to face or via conference call with the main European Health Authorities or with the key territories identified.

Scientific advice meetings require significant time to prepare your briefing document which each Health Authority will require in advance to getting that the face to face meeting with the Health Authority.  This process can take 3-6 months  and needs to be added to the timelines allocated in the regulatory strategy document. This also gives the Marketing Authorisation Holder an opportunity to meet with the EU HA’s and to hear the concerns that could arise during the assessment phase. It also allows the Regulatory team to advise the Marketing Authorisation Holder how best to mitigate any risks that could potentially arise during the assessment phase.  This step is often not built in to the planning phase and dossiers are frequently submitted in haste to meet a client deadline.

Another Common Pitfall

Another common pitfall experienced is the careful management of the national phase, following successful completion of the European procedure. In contrast with a US registration, where the company needs to obtain a single letter of approval from the FDA, the European process is far more complex.   In Europe, after a positive conclusion of the MR/DC procedure, high-quality national translations of the final SmPC/PL/labelling text should be submitted  to each of the countries involved in the procedure within 5 days  in order to obtain national approval. In many EU countries there is more than one local language, and we would recommend checking the quick reference document  CMDh/259/2012, Rev 1Languages to be used for Marketing Authorisation Application (MAA), Variations and Renewals National, Mutual Recognition and Decentralised applications’ before submitting your translations.  To ensure that you have available the high quality translations within the 5 day timeline, we would recommend preparing your draft translations at the earliest possible opportunity, and certainly no later than the start of assessment phase II.  While issues frequently arise with the proposed text of the SmPC throughout the assessment phase, it is nonetheless possible to be thinking ahead  and have more than one draft version available should late decisions be made with the SmPC text.  All too often, poor quality translations are submitted because insufficient time was allocated to this process.  This will ultimately lead to delays with the national approval process, and could even lead to rejection by the national HA.

Unique Additional Requirements

Many EU HA’s have additional unique requirements specific to their country only. For example, registration of the company for the first time on the HA portal system, delays in obtaining unique access codes and pin details to enter the medicinal product information onto the HA portals (e.g . Italy, Portugal). Many or in fact most of the European HA’s have national forms that need to be completed.  Frequently these forms require an authentic signature and often by the CEO or a named representative of the Board.  [This of course can be problematic, if the CEO is unavailable at short notice due to travel commitments, or is not located in Europe]

Some HA’s still require original signed versions of the mock-ups, or electronic application forms (eAFs) .  Some expect you to personally deliver the national documents rather than sending these by email.

How We Manage The Process

For projects such as this, we appoint an experienced and dedicated Project Manager to work with our clients throughout this journey and help guide them through the intricate European regulatory processes. We have a team of experienced professionals who have the necessary skills to negotiate on your behalf with the various Health Authorities across Europe.   We will work with you to  plan the best possible options available to you to ensure a successful outcome.  Acorn Regulatory was established over 17 years ago, and we have never yet received a single rejection, and we continue each day to build on this reputation.

If you would like us to help you with this issue then please get in touch with us.  Simply complete the webform below or call us on 00353 52 61 76706.

About the Author
Gemma Robinson, PhD
Managing Director
As Managing Director of Acorn Regulatory, Gemma Robinson is actively involved on client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance and clinical trial experts.  Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects. You can read more articles by Gemma by clicking the link below.
Other articles by Gemma Robinson PhD