Turn stones into milestones
A seasoned expert can draw on his or her experience of translation and official processes to smooth the way. Above all, he or she can do so quickly and on schedule, and this is essential for the authorization process.
To prevent misunderstandings with the authorities, the expert can play the role of intermediary. They can then take over communications with the manufacturer‘s in-country representatives and the national authorities.
Speed is also of the essence in the final stages. One of the last stages is the meeting held by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). This body issues recommendations as to the vaccine’s suitability to be authorized.
A medicinal product authorization (Regulatory Affairs) can indeed fail due to errors in the labelling documents. The choice of language service provider to carry out the translations is therefore of key importance.
If the committee agrees to the authorization only under certain conditions, the applicant has to rectify the shortcomings. These conditions can also concern the labelling documents, the product information. If the Committee for Medicinal Products for Human Use requests changes to the text, the language service provider has to incorporate them into all 24 language versions in next to no time.
If the applicant and its language service provider are unable to implement the requested changes on time, the European Commission can refuse the application even just short of the goal.
To prevent this, mt-g’s project managers work with the specialist medical translators and quality checkers even on the weekend at this stage. In addition, the specialist translators are very well acquainted with all requirements in the medicinal product authorization field and will already have been working with mt-g successfully for years.
One soothing side effect: Due to continued project completion successes, mt-g can always qualify new specialist medical translators. Even in peak periods, colleagues work at optimum capacity and can accommodate new projects. In this way, operations run according to plan even in the final stage, despite deadline pressure.
The project managers in the Global Regulatory Affairs section look after the medicinal product authorization area, with a reliable routine and with expertise acquired over the course of years. They can coordinate communication with the authorities and they comply optimally with all required specifications. Not even the subsequent checking process (linguistic review) by the national authorities presents an obstacle to them; rather, it‘s a milestone agreed regularly with the client.