The fresh new PSUR is not necessarily the appropriate procedure for submitting final otherwise interim analysis profile toward Eu regulatory bodies. Latest research profile are submitted and you can reviewed via the appropriate process according to research by the guidance to the information on brand new some categories of variations, toward businesses of your own methods put off when you look at the Chapters II, IIa, III and you will IV out-of Fee Control (EC) No . To possess centrally authorised activities meantime investigation accounts maybe not affecting for the device guidance or to the standing as mentioned regarding Annex II of one’s sales authorisation is going to be registered as a post-authorisation level (PAM) because explained concerned Exactly how and also to which shall We fill in my personal PAM analysis (find Article-authorisation actions: concerns and you can solutions)?.
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