Product-information templates: update

28 juin 2019

BlueRegWatch

As of 28 June 2019, any new marketing authorisations application submitted via the centralised procedure should comply with the revised QRD template v10.1 as early as possible and by Day 181 of the procedure the latest. EMA encourages holders of existing marketing authorisations granted by the centarlised procedure to use the first upcoming regulatory procedure affecting the product information annexes (such as line extension, renewal, variation, etc.) to comply with the revised QRD template.

BlueRegWatch

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