Qualification of Customers - What needs to be considered?

Wholesale distributors must verify that their customers are authorised to purchase medicinal products. 

Legal Background

According to chapter 5.3. of the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01), the following applies:

Wholesale distributors must ensure they supply medicinal products only to persons who are themselves in possession of a wholesale distribution authorisation or who are authorised or entitled to supply medicinal products to the public.

Checks and periodic rechecks may include: requesting copies of customer’s authorisations according to national law, verifying status on an authority website, requesting evidence of qualifications or entitlement according to national legislation.

Wholesale distributors should monitor their transactions and investigate any irregularity in the sales patterns of narcotics, psychotropic substances or other dangerous substances. Unusual sales patterns that may constitute diversion or misuse of medicinal product should be investigated and reported to competent authorities where necessary. Steps should be taken to ensure fulfilment of any public service obligation imposed upon them.

Rationale for this point

The reasons are comparable to those for the qualification of suppliers according to chapter 5.2. of the EU GDP Guidelines. It is about safeguarding the supply chain of medicinal products and reducing the risk of products being misdirected or misused.

It is also intended to minimise the risks of products not being stored and transported to appropriate GDP standards. This is to protect patients, as incorrect storage and transport may have negative impact on the quality of medicinal products.

Implementation

The following points should be considered:

• The qualification should be performed prior to any supply activities;
• The approval of customers should be defined in a Standard Operating Procedure (SOP);
• There should be periodic rechecks;
• The whole process should be documented;
• Documents should be kept and should be easily available in case of regulatory inspectors and audits.