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 (Active Product Ingredients, API's) that can be reused as active substances in veterinary medicinal products.
GDP requirements
The following implementing regulations pertain to Good Distribution Practice (GDP):
- Commission Implementing Regulation (EU) 2021/1280 as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products (GDP);
- Commission Implementing Regulation (EU) 2021/1248 as regards measures on good distribution practice for veterinary medicinal products (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 European database for 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, are being populated as of January 28 2022. Data about substance owners and wholesalers are added to the database. This information is currently not yet complete. 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.
GDP inspections
From 28 January 2022, wholesalers of veterinary medicinal products must comply with the GDP requirements. To check if companies comply with these requirements, GDP inspections will eventually be carried out.
The Netherlands Food and Consumer Product Safety Authority (NVWA) will be responsible for monitoring that traders in veterinary medicinal products comply with the applicable laws and regulations. The NVWA will also be performing the GDP inspections, and it is currently working out the details of this.
For more information about GDP inspections, please contact the NVWA.
Note:
No GDP certificates will be issued in the Netherlands for veterinary medicinal products as yet. This is because there is currently no legal basis for this in Regulation (EU) 2019/6.
Further information
- Further information on GDP is available on the EMA website under GDP.
- Further information on distribution and GDP for human medicinal products is available on the website of the Health and Youth Care Inspectorate (IGJ).
If you have any further questions about GDP, please feel free to contact the Veterinary Medicinal Products Unit.