EMA gives Clarification to the Variations Guideline in a Q&A Document

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:

  • General information about questions from the marketing authorisation holder to the competent authority
  • New classification category C.1.11 - changes with regard to the obligations and conditions of a marketing authorisation, including the risk management plan
  • New classification category C.1.13 -  other variations not specifically covered elsewhere in this annex which involve clinical and non-clinical studies
  • Impact on post-authorisation measure (PAM) submissions (see our News from 15 July 2013)
  • Revised classification category C.1.8 - introduction of, or changes to, a summary of pharmacovigilance system for medicinal products for human use
  • New classification category A.8 - changes to date of the audit to verify GMP compliance of the manufacturer of the API

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.

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