Approval of suppliers

Updated 01 December 2015

Wholesale distributors, parallel importers and parallel distributors must approve their suppliers

We have seen instances of falsified medicinal products in the legal supply chain in the EU, because wholesale distributors have used false company authorisations.

Consequently, it is important that companies involved in wholesale distribution of medicinal products ensure that they only receive medicinal products from companies authorised to wholesale distribute or manufacture the relevant products. See section 21 of the Danish executive order on good distribution practice (GDP).

Qualification of suppliers of medicinal products

According to the GDP guidelines, companies must qualify and approve suppliers before they receive any medicinal products.

Companies should pay special attention to assessing the suitability, competence and reliability of the supplier before entering into a new contract with new suppliers.

Pharmaceutical companies, such as wholesale distributors, parallel importers and parallel distributors, must adopt a procedure for this qualification and approval, and they must document and review the approval regularly.

See the GDP guidelines, section 5.2 for more information on qualification of suppliers.

Verification of authorisation

When a wholesale distributor receives a company authorisation from a supplier, the wholesale distributor must make sure that the authorisation covers the supply of the desired medicinal products and that the authorisation is still valid. In addition, the distributor should check that the authorisation is authentic - generally, by checking that it is registered in the EudraGMDP database.

The EudraGMDP database is an EU community database maintained and operated by the European Medicines Agency (EMA). The national regulatory authorities upload authorisations and certificates. The database contains information about manufacturers and wholesale distributors in the EU/EEA.

It is a relatively new feature that the authorities can upload wholesale distribution authorisations to the EudraGMDP database. Consequently, the database does not contain all wholesale distribution authorisations in the EU/EEA. Thus, a supplier may have an authorisation even though it does not appear from the database. The reason may be that the national regulatory authority which issued the authorisation has not yet uploaded it to the database.

Therefore, the wholesale distributor has to check the authenticity of the authorisation via the relevant regulatory authority if no search results are found in the EudraGMDP database. You can search the lists of authorised companies on the website of the issuing regulatory authority or – if such lists are not available – contact the authority.

Contact details of the regulatory authorities in the EU are available at EMA’s website

Search the EudraGMDP database

In the EudraGMDP database, you can search for Manufacturing and Importation Authorisations (MIAs) under the ”MIA” tab. You can search for Wholesale Distribution Authorisations (WDAs) within the EU/EEA under the “WDA” tab. You can search for GMP certificates under the ”GMP” tab and for GDP certificates under the ”GDP” tab. Certificates are issued by the authorities when they have inspected a company.

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