The European Commission has published an aide memoire for Good Distribution Practices (GDP) inspection of wholesalers’ compliance with Commission Delegated Regulation (EU) 2016/161 for safety features. The six-page document has been available online since 18 November 2019.

The document deals both with general questions and with more specific topics such as the wholesaler’s quality system, records, returns, suspected falsified medicinal products, recommissioning of unique identifiers (UIs), training and outsourced activities. The document also contains references to guidelines and articles within Regulation 2016/161.

 

 more information  AIDE MEMOIRE FOR GDP INSPECTION OF WHOLESALERS COMPLIANCE WITH COMMISSION DELEGATED REGULATION (EU) 2016/161 FOR SAFETY FEATURES.