Individuals or companies that sell or supply human medicines to anyone other than the patient must have a wholesale dealer licence. 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.
Here are some top tips on customer and supplier verification to consider when applying for a wholesale dealer licence:
Customer and supplier verification, and due diligence checks are crucial.
- 3 key steps to qualify suppliers (and customers):
- All suppliers and customers must comply with Good Distribution Practice. For wholesalers a copy of a current Wholesaler Dealers Authorisation (WDA) is required. For export customers you need to confirm their authority to handle medicines, the company registration and Health Ministry licence. GDP certificates should be obtained where possible.
- Due diligence checks must be carried out on suppliers, customers and freight forwarders. Checks should include, but are not limited to: WDA licence, company details, and size of business, types of transportation, destinations and company website checks.
- Additional checks with the regulatory authority for medicines in the country concerned should be carried out and outcomes documented. Any obtained licence should be translated into English and authenticated by a notary with appropriate due diligence carried out.
- Suppliers and customers should be re-checked annually.
Other things to consider are:
- Ensure you have a robust Quality Management System in place, which includes a Quality Manual, SOPs and controlled forms. All staff involved in wholesale dealing will require relevant and regular training in GDP.
- Premises should be fit for purpose, with temperature monitoring and always be kept clean and free of rubbish, dust and vermin, with appropriate records.
- The Responsible Person must be suitably qualified for the role.
If you have any questions about obtaining a Wholesale Dealer Licence or Broker’s Licence, or you require a Responsible Person, please get in touch via our contacts page for an initial chat.