EudraGMDP database is the European database for manufacturing and wholesale distribution. This database contains such information as permits and certificates issued to manufacturers, importers and wholesale distributors of human or veterinary medicinal products. The database is maintained and managed by the EMA. The EEA’s national competent authorities (NCAs) populate the database.
Access to the EudraGMDP database
A publicly accessible version of the database is available. No login is required for this.
The EudraGMDP database contains the following data (modules):
- MIA (Manufacturing Import Authorisation)
- GMP certificates
- WDA (Wholesale Distribution Authorisation)
- API REG (Active Product Ingredient Registration).
NB The GDP module only contains GDP certificates for human medicinal products at present. No GDP certificates are issued for veterinary medicinal products for the time being.
The competent authorities in the EEA member states and the European Medicines Agency (EMA) have full access to all data in the EudraGMDP database.
The authorities of EEA member states enter data into the EudraGMDP database to make it available. In the Netherlands, the authorities for human medicinal products are Farmatec and the Health and Youth Care Inspectorate (IGJ) and the authority for veterinary medicinal products is the Veterinary Medicines Bureau (BD).
Overview of information EudraGMDP database
The EudraGMDP database contains the information (modules) below.
Manufacturing Import Authorisation (MIA)
A manufacturing permit (F) is required for the purposes of manufacturing (incl. importing) veterinary medicinal products within the European Community. Likewise, one of these permits is also required for the import of veterinary medicinal products into a member state from third countries. EudraGMDP contains an overview of all manufacturing import authorisations for veterinary medicinal products.
GMP
Manufacturers or importers of veterinary medicinal products are also required to comply with the good manufacturing practice (GMP). The Health and Youth Care Inspectorate (IGJ) is the regulatory body and carries out GMP inspections to monitor compliance. Following an inspection and on the advice of the IGJ, the Veterinary Medicines Bureau will issue a Certificate of Good Manufacturing Practice if it turns out that the party inspected is compliant. The EudraGMDP contains an overview of all GMP certificates issued and withdrawn.
If a GMP inspection reveals that a manufacturer is not GMP-compliant, a statement of non-compliance will be issued. This GMP non-compliance statement will also be recorded in EudraGMDP.
Wholesale Distributor Authorisation (WDA)
Anyone purchasing, storing, distributing or exporting veterinary medicinal products in the Netherlands must hold a wholesale distribution permit. In the Netherlands, this wholesale distribution permit (G) for veterinary medicinal products is issued by the Veterinary Medicines Bureau (BD).
As a matter of course, the BD will visit a company prior to issuing a permit to ensure that the company is compliant with the wholesale distribution requirements.
GDP
A certificate of good distribution practice (GDP) will be issued to a wholesale distributor by the national competent authority that has carried out a GDP inspection if the inspection confirms that the wholesale distribution activities are GDP-compliant.
In the case of human medicinal products, GDP inspections are conducted by the IGJ and they also issue the GDP certificates.
NB The GDP requirements also apply to veterinary medicinal products from 28.1.2022 onwards. Each and every wholesale distributor of veterinary medicinal products will need to be GDP-compliant from that date onwards.
In due course, GDP inspections will also be carried out at wholesale distributors of veterinary medicinal products. The Netherlands Food and Consumer Product Safety Authority (NVWA) is the regulatory body for the entire veterinary sphere and hence will also be responsible for carrying out GDP inspections. At present, there is no legal basis in the Regulation on veterinary medicinal products (2019/6) for the issuance of GDP certificates, so these are not being issued in the Netherlands for the time being.
Active Product Ingredient Registration (API REG)
Manufacturers, importers and/or distributors in possession of active product ingredients (APIs) that can be used as a raw material in veterinary medicines are required to notify the Veterinary Medicines Bureau (BD).
EudraGMDP contains an overview of all manufacturers, importers and/or distributors in possession of active product ingredients (APIs) that can be used as a raw material in veterinary medicines.
OMS
You must register in the Organisation Management Service (OMS)-database of the European Medicines Agency (EMA), otherwise we, as the Veterinary Medicinal Products Unit (BD), cannot process your manufacturing license or certificate (MIA), your wholesale license (WDA), or your registration for the veterinary raw materials register in this database. If you are not registered with the OMS, you will not be visible in the European database for manufacturers, importers and wholesalers (EudraGMDP). More information about OMS can be found on Organisation Management Service (OMS).
Further information on the EudraGMDP database
Information on the EudraGMDP database can be found here on the EMA’s website. Article 91 of the Regulation on veterinary medicinal products sets out the requirements for the EudraGMDP database.
If you have any further questions about the EudraGMDP database, please feel free to get in touch with the Veterinary Medicines Bureau (BD) using our contact form.