Is a copy of a WDA(H) enough evidence to approve a supplier?
NO!
Evidence of a WDA(H) is just one of the steps required for supplier approval. If obtaining the product direct from manufacturer or from another wholesaler the authorisation is no longer enough.
The Guidelines on Good Distribution Practice of Medicinal Products for human use (5th November 2013 – 2013/c 343/01) now requires an enhanced level of bona fide check.
What do you need?
1) WDA(H) or MA must be obtained in its entirety
2) GDP or GMP status must be checked on the EUDRA website
3)
A) GDP certificate if applicable must be obtained
B) Copy of the supplier’s last inspection letter
4) ‘Due Diligence’ Checks
What could constitute as a ‘Due Diligence’ check?
- Is the company registered with company house?
- Does the company have a VAT number? How do you verify this?
- How long has the company been trading for?
- What is the company’s credit history look like?
- Do you need to carry out an audit before commencing business with this supplier?
- Is the product a new line for you?
- What are the quantities and pricing? – could it be falsified?
- Is it a reputable company?
What do you need to monitor on a regular basis?
- Suspended Authorisations
- EudraGMDP website none-compliance reports
The moral of the story is check, recheck and recheck! FOr more information of Bona Fide checks or Wholesaling in general contact Pharmacy Consulting on 01252 302342