The World Health Organization (WHO) today released its final draft of Model requirements for the storage and transport of time and temperature sensitive pharmaceutical products for general public review. Review and comment period is open until July 31st, 2010.
This long-awaited guideline, prepared in close consultation with the WHO Task Force on Regulatory Oversight on Pharmaceutical Cold Chain Management, outlines the principal requirements for the safe storage and distribution of time and temperature-sensitive pharmaceutical products. It is based upon existing regulations and best practice guidance from a wide range of international sources, while accepting that local legislation and regulations will continue to take precedence. The final version will be prepared incorporating comments received from this public review. The document will then be submitted to Experts Committee on Biological Standardization and Experts Committee on Specifications for Pharmaceutical Products for their approval in October 2010.
More information, along with a printable pdf. file of the final draft, can be downloaded here. Please, forward your review comments on the document (no later than July 31, 2010) to:
Dr Ümit Kartoğlu by email [[email protected]][email protected][/email] or by fax +41 22 791 4384
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