An NSF International Company EU GDP Guideline revised again
Thursday the 28th November 2013
On 5 November 2025 a revision to the GDP Guidelines, which completely replaces the version that was issued in March 2013, was published. The November version, which became effective on 24 November 2013, corrects factual mistakes identified in sections 5.5 and 6.3 of the March 2013 Guidelines.
The new text in 5.5 says that “Medicinal products that are nearing their expiry date/shelf life should be withdrawn immediately from saleable stock either physically or through other equivalent electronic segregation.”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…”.
