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February 2023

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  • February 2023

February 2023

  • Time to update your veterinary product information?

    From the “new” Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) came into force on 28 January 2022, the QRD template v.9 has been obligatory for all MA applications.

  • High quality Norwegian product information

    The Norwegian Medicines Agency (NoMA) strongly encourages marketing authorisation holders (MAH) to focus on high quality translations of product information (PI): “The product information has to be easy to read and understand for the users. A higher quality of the product information will improve the patient information and contribute to safe use of medicines. There […]

February 2023

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