Has your company started to update product information texts for veterinary medicines according to the new EU regulation?
If your company is marketing veterinary medicines in the EU, now is the time to update your product information texts. According to the new EU regulation, all product information texts must be updated within a transition period ending in early 2027. Should you need help with this task, our regulatory affairs specialists and medical translators are ready to support you.
The regulations concerning veterinary pharmaceuticals changed in January 2022, when the new EU Veterinary Medicinal Products Regulation entered into force. One of the reasons for the comprehensive renewal of the Veterinary Medicinal Products Regulation was the EU’s aim to enhance the availability of veterinary medicines in European markets.
As part of the regulatory change, all product information texts must be updated to comply with a new QRD template in all the EU countries by 29 January 2027, which is the last day of the transition period. This applies to all veterinary medicines with a marketing authorisation in the EU. The change also affects package labelling.
“All product information texts and package labelling must now be updated in all national languages. This is quite a task. So even though there are still a few years of transition period left, it is a good idea to get started now,” notes Laura Riihimäki-Lampén, Head of Regulatory Affairs and Translations at Oriola.
“We are glad to help companies with this extensive undertaking. Our experienced regulatory affairs and translations team can support you in updating your product information texts according to the new QRD template and can also help you submit the variations to the regulatory authorities in all the Nordic countries. After the new product information texts have been approved, we can also update the new texts in the Nordic national databases, including the Finnish Pharmaca Fennica Veterinaria, Swedish Fass and Norwegian Felleskatalogen,” says Riihimäki-Lampén.
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