Falsified Medicines: New EU Aide Memoire for GDP

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.

General questions

The list of general questions starts with “Are there medicinal products in the portfolio of the wholesaler required to bear safety features?” Further examples for general questions are:

• "Are any products exempted under Annex I?"
• "Are any OTC products required to bear safety features under Annex II?"
• "Is the wholesaler a ‘designated wholesaler’?"
• "Are individual unique identifiers (UIs) scanned / are aggregated codes scanned allowing the simultaneous verification of multiple UIs?"

Specific Topics

Questions related to specific topics include:

• "Was serialisation for EU implemented at the site under change control?"
• "Is the number of scanners etc. appropriate?"
• "Have personnel received training?"
• "Are records kept for any transaction in medicinal products received and supplied (i.e. purchase/sales invoices, delivery slips, or on computer or any other form)?"
• "Is there a procedure in place for handling of suspected falsified medicinal products?"

Finally, the aide memoire notes that if the wholesaler has subcontracted to a logistics provider, the technical agreement/contract should be reviewed.

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