Wholesalers must ensure that their suppliers are permitted to supply pharmaceuticals.

Legal History

The following is applicable in accordance with chapter 5.2 of the EU GDP Guidelines (Guidelines on Good Distribution Practice of Medicinal Products for Human Use, 5 November 2013 – 2013/C 343/01):

Only individuals who themselves have a wholesale distribution authorization or who have a manufacturing authorization that covers the relevant product are permitted to supply wholesale distributors with medicines.

Wholesalers who receive medicines from other nations with the intention of importing them, or putting them on the market in the EU, must hold a manufacturing authorization.

When purchasing pharmaceuticals from another wholesale distributor, the receiving wholesale distributor is required to confirm that the supplier adheres to the fundamentals and best practices of good distribution practices, and that they hold authorization, for instance by checking the Union database. The wholesale distributor is required to confirm that the broker is registered and complies with Chapter 10 standards if the medicinal product was obtained through brokering.

Prior to making any purchases of medicinal supplies, vendors should be properly qualified and approved. A procedure should be used to control this, and the outcomes should be recorded and periodically examined again.

The wholesale distributor should apply “due diligence” before signing a new contract with a new supplier to determine the other party’s suitability, competency, and dependability. The following factors should be taken into consideration: I the reputation or dependability of the provider; (ii) offers of medications that are more likely to be faked; (iii) large offers of medications that are typically only offered in small amounts; and (iv) out-of-range costs.

Reasons why this is important

The above-mentioned restrictions were put in place in order to, among other things, prevent the supply of fake drugs through authorized channels.

Additionally, it aims to reduce the possibility of products not being transported and stored according to required GDP standards. As improper storage and transit could have a negative effect on the quality of pharmaceuticals, this is done to protect patients.

Implementation

It’s important to take into account the following:

  • Before engaging in any procurement operations, the qualification should be completed;
  • a Standard Operating Procedure (SOP) that specifies the criteria for supplier selection, qualification, and approval should be used;
  • Appropriate “due diligence” checks should be included in the first supplier clearance;
  • In there should be appropriate technical/quality agreements;
  • Periodic rechecks should be performed because authorizations can alter over time;
  • Requalification should be carried out using a risk-based methodology;
  • The entire procedure should be recorded;
  • In the event of regulatory inspections or audits, documents should be preserved and kept in a readily accessible location.

How to Determine if a Supplier has a Wholesale Distributor Authorization (WDA)?

It is advised to use the EudraGMDP database. The national competent authority of the member state where the wholesale distributor conducts business in the European Union (EU) issues wholesale distribution authorizations (WDA). The certificates of good distribution practices that the member states issue must be entered in the EudraGMDP. The European Medicines Agency oversees and manages this database (EMA). A so-called GDP non-compliance report is produced if an inspection reveals that the wholesaler’s GDP compliance cannot be verified.

A copy of the supplier’s authorization should be requested in addition to accessing the EudraGMDP database.

 

SOURCE: https://www.gmp-compliance.org/gmp-news/qualification-of-suppliers-what-needs-to-be-considered

OUR SERVICES: Supply Chain Mapping, Clinical Services, Commercial Services, General Services