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Back to the forum  2018-06-22 15:29 CEST (UTC+2h)

New EMA guideline: Handling and shipping of IMPs [BE/BA News]

posted by Helmut Homepage - Vienna, Austria, 2018-05-24 15:45  - Posting: # 18814
Views: 374

Dear all,

today the EMA published the “Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice”. End of consultation is on 31 August 2018.

Have also a look at the applicable guidelines on Good Distribution Practice (GDP):

Cheers,
Helmut Schütz
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