IPEC e-newsletter - Excipients Insight November 2017 - 22-11-17

 

Inside this issue

     

Brief: CVMP drafts implementation guide for elemental impurities

The EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) has drafted an implementation guideline that is intended to help regulators elaborate guidance on the appropriate approach for an elemental impurities risk assessment for veterinary medicines.

Regulatory action is not expected at this time and routine submission of risk assessments via variations, or otherwise, is not envisaged. Further guidance of expected regulatory actions will be elaborated and published in due course, says the document.

 

 

 

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