thirty two. Can PSURs remain submitted having renewal app?

Posted by Richard in postordre brudinformasjon on January 31st, 2025

To own CMDh reputation by consensus: as per the dateindicated from the interpretation timetable we.age. 105 step 1 calendar days shortly after use of CMDh status.

To have CMDh position from the consensus: according to the big date conveyed regarding the interpretation plan i.e. 105 step 3 calendar days once use of your CMDh reputation.

PSURs, PSUR addendums, summation bridging accounts and you may range listings would be to not getting filed as an element of a renewal application. Brand new logical evaluation registered on revival application includes related information to help with the advantage-risk lso are-evaluation of the medicinal tool. Read the rest of this entry »

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