Update multi-language labelling in EU

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    Update multi-language labelling in EU

    Update multi-language labelling EU

    Looks like January was a productive month for CMDh. On their last meeting they have agreed to publish a set of links with special guidance on update multi-language labelling EU developed by some Member States. The update of multi-language labelling in EU will be available under “Product Information” on their website section.

    As an illustration, if you have products in Finland, Sweden or Belgium, this is a great piece of news. Regarding those countries, multi language packaging is mandatory. Especially, when you are preparing your SmPC, PIL and Labels. You have to focus not only in content and current QRD but also in the local guidelines and recommendations. With this in mind, it is especially tricky on those countries where labelling is in different languages as you have to check different sources. Finally, most of the information of EU regarding this topic will be centralized.

    Baupharma is a service provider for pharmaceutical companies, covering Regulatory AffairsPharmacovigilance and Business Development. Our regions of expertise are EUCIS and MENA.

    If you want further information, feel free to contact us at info@baupharma.com