Good distribution practice (GDP)

Good Distribution Practice sets out the requirements that wholesale distributors must satisfy throughout the EEA. 

Compliance with GDP ensures that: 

  • the quality and integrity of veterinary medicinal products are preserved throughout the supply chain
  • veterinary medicinal products are admitted into the supply chain in accordance with the laws of the European Union (EU)
  • veterinary medicinal products are stored under proper conditions at all times, including during transport
  • contamination by or of other products is avoided
  • there is satisfactory turnover of stored veterinary medicinal products
  • the right products are delivered to the right recipients within a satisfactory time frame. 

The GDP requirements also apply to the procurement, storage and transport of starting materials that can be reused as active substances in veterinary medicinal products.

GDP requirements

The following implementing regulations pertain to Good Distribution Practice (GDP):

 These regulations apply to:

  • starting materials used as active substances in veterinary medicinal products;
  • end products used as veterinary medicines.

Broadly, these GDP requirements for veterinary medicinal products are similar to the applicable requirements for human medicinal products.

EudraGMDP database

The EudraGMDP database is the existing database for production and wholesale distribution. It contains all licensed manufacturers, importers and distributors of both human and veterinary medicinal products. 

The information is subsumed under the following modules in this database: 

  • Manufacturing/Importation Authorisation (MIA); 
  • Good Manufacturing Practice (GMP) certificates; 
  • Holders of starting materials (API REG);
  • Wholesale Distributor Authorisation (WDA).

These last two modules, API REG and WDA, will be populated over the course of 2022. At present, they do not contain any data pertaining to veterinary medicinal products.

The Veterinary Medicinal Products Unit will be entering the veterinary medicinal products data into the EudraGMDP database. 

Please note: companies can only be added to the EudraGMDP database if they are featured in the OMS.

Further information

If you have any further questions about GDP, please feel free to contact the Veterinary Medicinal Products Unit.