Guidelines on GDP revised

Only eight months after their publication, the Guidelines from 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use have been revised.

But those who were hoping for major changes and possible less stringent regulations will be disappointed. The new version corrects factual mistakes identified in subchapters 5.5 and 6.3 of the revised guidelines. It also gives more explanations on the rationale for the revision as well as a date of coming into operation. However it completely replaces the guidelines on GDP published in March 2013.

The new text in 5.5. says that "Medicinal products that are nearing their expiry date/shelf life should be withdrawn immediately from saleable stock either physically or through other equivalent electronic segregation."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 old text, also medicinal products that are already beyond their expiry date were included.

The changes in 6.3 were necessary because they might have led to misunderstandings. The revised text requires 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...".

Here you will find the 5 November 2013 version of the "Guidelines on Good Distribution Practice of medicinal products for human use".