One of the most important aspects of wholesale distribution is maintaining the integrity of the supply chain and preventing falsified medicines from getting to the public. Do not purchase medicinal products from unapproved supplier!
/EUROPEAN COMMISSION Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (Text with EEA relevance) (2013/C 343/01) 5.2. Qualification of suppliers/
Please make the following steps before purchase:
1: First you have to verify that supplies of medicinal products only come from persons who are in possession of a wholesale distribution authorisation, or a manufacturing authorisation. Only original copy of the licence can be accepted.
2: Double check the licence they sent you. Use the EudraGMDP website (or if UK supplier, licence can be checked from the MHRA website). Unfortunately, the EudraGMDP website does not contain details of the legal categories of products that can be handled or 3rd party sites used, but shows the inspection date and the length of the licence can be hold.
3: Due diligence checks should be carried out in order to assess the suitability and reliability of the supplier. Points should be considered:
- checking the financial status of the supplier
- Not requesting paying from an off-shore account
- VAT number check
- Company check
- Website check
- Product being offered available in quantities or volumes.
4: Print a copy of the appropriate pages, sign and date as evidence the checks were made, when and by whom, this way you can demonstrate your qualification of suppliers.
5: Do not forget, to re-check your supplier at least annually, re-validate the information you hold on your supplier(s).
And last but not least. Have you created a robust SOP on qualification of suppliers?
Written by Adel Nagy