Know your Supplier!

by | Feb 5, 2021 | Blog, Brexit

Companies who hold a wholesale licence must understand the obligations placed on them by the Human Medicines Regulations 2012 Regulation 44 (2) and (3) and Good Distribution Practice in relation to the qualification of suppliers.

  • Verify the licence in the MHRA Approved List if the wholesaler or manufacturer is based in the UK

Public access to the MHRA-GMDP database can be found following this link https://cms.mhra.gov.uk/mhra

Verify the Licence in the  EudraGMDP database if the supplier is based in the EEA or Northern Ireland

Public access to the EudraGMDP database can be found by following this  link. http://eudragmdp.ema.europa.eu/inspections/logonGeneralPublic.

  • Check compliance with GDP

Check the suppliers GDP certificate

  • Bona Fides Checks

The financial status of the supplier, how long have they been trading, and do they have an acceptable credit history. Companies house checks, Vat checks, website checks 

Has an audit been performed of the supplier, or has anyone in your company visited them?

Where is the stock coming from? Do you know the history?

Is the product being offered available in unusually high quantities  or the  price being offered is lower than usual price?

What will be the method of transportation?

For companies that source medicines from a third country for export to third countries must document that checks are made to show that where the medicinal product is directly received from a third country (“A”) for export to a third country (“B”), the supplier of the medicinal product in country A is a person who is authorised or entitled to supply such medicinal products in accordance with the legal and administrative provisions in country A. licences obtained should have been translated into English and authenticated by a notary with appropriate due diligence carried out.

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