Friday 8 January 2016

MHRA Guidance Seeks to Clarify Baseline Submissions

The UK’s Medicines and Healthcare products Regulatory Agency is clarifying definitions of baseline submissions for dossiers and when they should be used.

Baseline submissions usually are required when converting the format for regulatory submissions or correcting technical issues for previously supplied documents, MHRA says in guidance released last week. The agency defines a baseline submission as the submission of all current valid documents, as well as a statement that only the format—and not the content—has been changed.

MHRA recommends that baselines are applied when there are no pending regulatory activities for the product.

Posted by Dr. Tim Sandle

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