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.
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.