EU Article 31 referral started [GxP / QC / QA]

posted by Ohlbe – France, 2022-01-24 18:47 (905 d 08:40 ago) – Posting: # 22754
Views: 5,136

Dear all,

❝ Europe: it should not take them more than a year or two to decide what to do :sleeping:


Mmmm. It looks like things are moving a bit: according to the Agenda of the January CHMP meeting an Article 31 referral is being triggered (see page 32 of the PDF). Will take some more months before the referral is concluded and the Commission decision gets published and implemented.

Malaysia announced their decision almost 2 months ago.


Edit: detailed information on the referral is now available here [Ohlbe].

Regards
Ohlbe

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