Using a US Dossier for a European MA Application? Here Is What You Need To Know

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.

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 have discussed this in an earlier article ‘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 the 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 1 ‘Languages 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 16 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 form below or call us on 00353 52 61 76706. [ninja_form id=1]