Bona Fides … What?
Bona fides is a Latin phrase meaning ‘good faith’ and is the opposite of mala-fide (‘in bad faith’)
The Oxford Dictionary defines it clearly as
“evidence that somebody is who they say that they are; evidence that somebody/something is honest”
Although not explicitly mentioned in the EU 2013/C 343/01 GDP Guidelines, Bona Fide is a term often used within the wholesaling industry including regulatory bodies such as the MHRA.
With the complexity of the modern day supply chain it is essential Good Distribution Practice principles are maintained across all distribution channels to guarantee the integrity of human medicinal products till they reach their final end point, the patient.
The context in which the phrase ‘ Bona Fides ‘ is used is in response to the many references within the EU 2013/C 343/01 GDP Guidelines which refer to the ’approval of suppliers and customers’ . In other words, are your suppliers and customers who they say they are i.e. licensed to deal with the wholesaling of medicines, compliant with the GDP guidelines or in possession of a MA (marketing authorisation).
How often should you undertake Bona Fides checks?
The standard official answer to the question ‘How often should I undertake Bona Fides checks?, is:
“Periodically such that you are confident that your suppliers and customers remain approved”
Organisations should ensure they have robust Quality Procedures in place for the approval of customers and suppliers.
In practical terms this means:
1. Regular periodic checks or at a minimum annual checks requesting evidence of:
- Qualifications according to national legislation. In the UK this would be the Wholesale Distribution Authorisation for Human Medicines or WGA (H) as issued by the MHRA. You need to ensure you receive all pages of this document.
- A copy of GDP Certificate from EUDRA GMDP. If not available ask for the post inspection letter confirming the site was inspected.
2. Monthly checks on the MHRA Suspended or Revoked Licences list. If any of your customers or suppliers is listed, you must cease trading with them immediately.
3. Professionals approaching you for purchase must be checked and verified with their registration bodies at least every 3 months:
- Pharmacies – check against the GPhC register.
- Doctors – check on the GMC register.
- Dentists – check on the GDC register
- Podiatrists – check on the HCPC register.
- GP Surgeries and Hospitals – check the CQC register.
4. Other due diligence checks which are recommended:
- Obtaining a copy of the Certificate of Incorporation and verifying this with Companies House
- Requesting a copy of the VAT registration certificates
- Confirming the location of the site using Google Maps
- Reference checks
- Reputational risk analysis using social media tools
The RP should sign and date copies of all the above documents and they should be held in the customers or suppliers file. Evidence of all subsequent checks should be held to maintain an audit trail as they may be required by the MHRA Inspector.
If you are ready to work with us, or would like to discuss in further detail about how we can help you and your organisation please contact our office and send us your request, or schedule a free initial telephone consultation.