Thursday, 13 August 2020 14.00 - 15.30 h
On 16 May 2013, the "detailed guidelines on procedure issues and the classification of variations" were published. The document has integrated the updates made with regard to amendments to the variations and the provisions of the Variations Regulation (EU) No 712/2012 (see our News from 3rd July 2013).
As for all guidelines of considerable complexity, there are still questions open regarding this regulation. The EMA has clarified these issues in a Q&A document published on 3rd September 2013. The following topics are addressed:
According to the "detailed guidelines", an alternative date for an audit of the API manufacturer is a variation type IA unless the information has been otherwise transmitted to the authorities (for example through a "QP Declaration"). Clarification has been necessary to define the notion "otherwise". According to the answer in the Q&A document, this means that the transmission of the information regarding the change in an audit date has been provided to the competent authorities within any formal regulatory procedure. In these cases, no separate variation application for the change has to be submitted.