Hyperion Pharma Consultancy

The Netherlands

Vlasmeerstraat 90
5261 TC Vught

P: +31 (0) 641221798 
E: info@hyperion-consultancy.nl
W: www.hyperion-consultancy.nl

 contact page 
New Version of EU GDP Guidelines

News about GMP/cGMP

New Version of EU GDP Guidelines

A new version of the Guidelines on Good Distribution Practice (GDP) of medicinal products was published by the European Commission.
The revised guidelines correct factual mistakes in subchapters 5.5. and 6.3., give more explanations on the rationale for the revision and provide a formal date of coming into operation. These guidelines, which replace the guidelines on GDP published in March 2013, are applicable as of 24 November 2013.

 

The new version does not comprise significant changes.

In subchapter 5.5. the actual text says that "Medicinal products that are nearing their expiry date/shelf life should be withdrawn immediately from saleable stock either physically or through other equivalent electronic segregation." In the former text, medicinal products that were already beyond their expiry date were included.

In subchapter 6.3. the revised text states that "medicinal products returned from a customer (…) should only be returned to saleable stock if they are returned within an acceptable time limit, for example 10 days". The old text required that they "should always be returned to saleable stock if they are returned within an acceptable time limit...".

Click here for the new GDP Guidelines of 5 November 2013.

Source:

EC: News and Updates gmp-publishing.com

Hyperion Pharma Consultancy uses cookies to analyze the use of the website. For example, through such statistics, it is examined how often you visit the website of Hyperion Pharma Consultancy. These cookies could also be placed by third parties. By accepting this announcement or continuing to use this site, you agree to this. More information