The process to getting medicinal products approved for sale in the European Union is lengthy and involving, and companies ignore it at their own peril.
There are three main procedures for submitting a Marketing Authorisation Application (MMA) in the EU, with the centralised procedure leading to one assessment process and one authorisation that allows access to the market of the entire EU. While the regulatory procedure itself is similar to that of other developed nations, the key to navigating this process in the EU is language. With the translations of all Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), label annex, etc. requiring the approval of Member States that use a total of 24 official languages (as well as Norwegian and Icelandic), this can seem a daunting obstacle for all but the largest corporations. Naturally, for most other companies, this means translation assistance; however, aside from just using any translation service only when you need it, understanding when, how, and the extent to which a Language Service Provider can assist your company can make a substantial difference in your regulatory experience.
First and foremost, echoing Benjamin Franklin, “if you fail to plan, you are planning to fail,” the time to worry about translations is not when you need them. Though the process itself begins in English and the first submission deadline for translated documents isn’t until Day 215, waiting until later in this timeline will not allow sufficient time for most LSPs to become acclimated to the process, which could potentially result in translations that, though correct, fail to give the applying company every possible advantage. Developing your translation strategy as early as possible will allow adequate time for a Language Service Provider to familiarise itself with the needs of your company, your authorisation application, and any modifications that need to occur in the application while the process is in its initial English-only stages. It is best practice to begin translation using the Day 121 versions of the English files upon the receipt of the Technical Labeling Review comments aimed to ensure compliance with current standards.
Beyond the hurdle of producing product information in 26 total languages, the language itself will also need to be approved by all Member States, where after the Day 215 deadline each translation will be subject to one Member States’ linguistic review. If translation is treated as a last consideration, delays in transmission to the European Commission can potentially arise from poor translations, failure to implement Member States’ comments on language used, or a failure to justify why Member States’ comments weren’t taken into consideration. The best way to avoid these costly delays is through open communication: understanding the needs, requirements, and wishes of each individual Member Country via an open dialogue can foster a favourable environment that can significantly aid your company’s application.
Once your product is authorised, the process may seem to be complete; however, this is no time to rest on your laurels. As regulations and drug formulations change or when specific drug variations are developed, it will be necessary to revisit portions of this process (depending on need) in the future in order to gain authorisation. An open, pro-active stance regarding the translation of essential material could easily help to cut the lag time between actual internal or external developments and the ability of a company to react to a dynamic marketplace involving substantial regulation.
While the market determines winners and losers, everyone in the pharmaceutical industry understands that the ability to traverse the regulatory maze is what determines market access. In the case of the European Union, using an LSP that is experienced with the pharmaceutical industry, regulatory processes, and virtually all Member States can be an invaluable asset in making your path to marketing authorisation easier.
EVS Translation has been working successfully alongside global healthcare providers, pharmaceutical companies, and medical device manufacturers for 25 years providing one-source globalisation and translation management solutions.
Production centres with in-house experts in all major EU markets guarantee unmatched scalability and QA capacities. 140 full-time employees and a network of vetted in-market reviewers allow us to offer the entire localisation life cycle, from human translations to automated translation solutions backed by a fully customisable workflow platform in more than 150 languages.
Avoid costly delays in EU marketing authorisation and ensure first-time successful product applications with the help of our in-house translation team. -> Contact EVS Translations today.