21. What are the timelines into submission off PSURs?
The brand new PSUR is not necessarily the appropriate procedure for submission last or meantime research profile on European union regulatory government. Final investigation account will be filed and you can assessed through the appropriate process according to research by the advice toward information on the fresh certain kinds of variations, towards functions of the actions placed down for the Sections II, IIa, III and IV of Commission Regulation (EC) No . To have centrally authorised products interim data records perhaps not impacting towards device information or to the standing as mentioned regarding the Annex II of one’s purchases authorisation shall be registered because the an article-authorisation size (PAM) as demonstrated in question How in order to just who will I complete my personal PAM investigation (select Blog post-authorisation steps: concerns and you may answers)?. (more…)
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