EMA GDP Guidelines for medicinal products

Sathyanarayana M.Sc.
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EMA Guidelines on Good Distribution Practice (GDP) of medicinal products for human use

EMA Guidelines on Good Distribution Practice (GDP) of medicinal products for human use

INTRODUCTION

These Guidelines are based on Article 84 and Article 85b(3) of Directive 2001/83/EC.

The Commission has published EU Guidelines on Good Distribution Practice (GDP) in 1994. Revised guidelines were published in March 2013 in order to take into account recent advances in practices for appropriate storage and distribution of medicinal products in the European Union, as well as new requirements introduced by Directive 2011/62/EU.


EMA GDP Guidelines for medicinal products:

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