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Side effects of medicines. Additional monitoring. News on pharmacovigilance. Biological and biosimilar medicinal products. Safety updates. Direct Healthcare Professional Communication. Adverse events.
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CE marking. Incident reporting. Notified bodies. Registration and marketing. Clinical investigations. Certificates of Free Sale. Legislation and guidance. Special product areas. Companies should refer to all relevant European Union legislation and guidelines when drawing up applications.
It is the company's responsibility to ensure that the product information complies with all such requirements. QRD template v As of 1 January , any new marketing authorisation application granted via the centralised procedure must comply with the revised QRD template v Ongoing marketing authorisation applications must align their product information to the revised QRD template v Holders of existing marketing authorisations granted via the centralised procedure must update the product information annexes by 31 December , in any regulatory procedure that affects these annexes, to comply with the revised QRD template.
Since 28 June , applicants need to complete Annex II and present a draft of this together with the summary of product characteristics SmPC , labelling and package leaflet when submitting the product information annexes as part of their marketing authorisation application.
Additional linguistic corrections in the Swedish and Finnish language templates have been implemented. Please do not include any personal data , such as your name or contact details. Skip to main content. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation.
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