What’s in the Latest Version of EMA’s Veterinary Product Information Template? 18 February, 2022 The European Medicines Agency has updated its veterinary product information template to support the implementation of the new Veterinary Medicinal Products Regulation which became applicable on 28th January 2022. In this article, we discuss what changes have been made, what triggered them, and what they mean for applicants and marketing authorisation holders of veterinary medicinal products.
What Are Our Predictions for the Life Science Translation Industry in 2022? 21 January, 2022 As 2022 begins, it’s time for life science organisations to start executing plans for the year ahead. Whether you’re entering a new export market or launching a new product in a country where you already have a presence, translation of your written content will be part of the all-important specifics, from regulatory paperwork to package labelling or marketing literature. How will the new trends in the life science translation industry affect your plans for the coming year? Will you pay less for your translation and have it done faster over the next 12 months? Read on for our insights into...Read more
Does Translation of COVID-19 Vaccine Files Mean Delays for EU Patients? 22 December, 2020 Will the EU rules for the translation of COVID-19 vaccine documentation cause unnecessary delays in getting regulatory approval for the EU market?
What changed in the latest EMA QRD template update 26 February, 2016 This month really got my heart racing, and it had nothing to do with Valentine’s Day. The one thing that releases large amounts of adrenaline in any pharmaceutical translator is an update of the EMA QRD template for product information. On 9th February 2016, the European Medicines Agency (EMA) published version 10 of the templates for product information for use by applicants and marketing-authorisation holders for human medicines, and I rushed to EMA’s official website to see what changes had been made to the reference documents we use religiously in our everyday work.