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THE PHARMA REVIEW (MAY JUNE 2015)

Comparative Study of Regulatory Requirements for Post - Approval Changes in Europe & South Africa

Sandeep Mandal & Balamuralidhara.V.

Introduction: Post Approval Changes or variations are the changes which are made to the already marketed drug product. Changes or variations in respect of any information concerning the registered or approved drug products, including information on the formulation of the registered / listed goods or other aspects of their manufacture, and the labeling of the goods, shall forthwith be notified to the agency and the change or variation shall not be implemented until approved by the agency1.

 

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THE PHARMA REVIEW (May - June 2015)

 

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PHARMA REVIEW - ARTICLES ARCHIVE (COMPLETE LIST)

The above content is an abstract only. For the full Article please contact:
KONGPOSH Publications Pvt. Ltd.
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