The updated database is a key part of the EU’s Falsified Medicines Directive (FMD), which was implemented in January and will register pharmaceutical and API (active pharmaceutical ingredient) manufacturers, distributors and importers.
EudraGMDP now contains:
- Manufacturing and import authorisations;
- GMP (Good Manufacturing Practice) certificates;
- Statements of non-compliance with GMP; and
- GMP inspection plans in countries outside the EU.
National competent authorities over the next few months will also upload data on wholesale distribution authorizations, GDP (good distribution practices) certificates, statements of non-compliance with GDP and the registration of manufacturers, importers and distributors of APIs in the European Economic Area (EEA). The EEA includes all EU member countries, as well as Iceland, Lichtenstein and Norway.
The addition of GDP data comes as the commission recently issued new GDP guidelines that are expected to increase manufacturer costs because of new requirements for quality systems and management representatives. This same section of the FMD also “includes new responsibilities for wholesalers and a definition of brokering activities as well as new responsibilities for brokers,” the commission adds.
But the database also advises users that “since inspections of manufacturers of active substances are based on risk, some active substance manufacturers may not be in possession of a GMP certificate issued by an EEA (European Economic Area) authority.” But the “absence of a GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GMP,” the database warns users. The EMA also does not claim responsibility for the database and directs users questions to member states’ competent authorities as they are the ones responsible for uploading the data.
EudraGDMP is a modification of EudraGMP, which first launched in May 2007 and aimed to support GMP certification coordination among member states, as well as to publicize more information about the process of certifying manufacturing facilities.
The modified database comes as the FMD introduced a new module, or regulation, on planning GMP inspections in countries outside of the EU in December 2012. This module, which is not publicly accessible, aims to share more information among EU regulators and avoid redundant inspections.
Falsified Medicines Directive
In addition to the expansion of the EudraGDMP, the FMD features a number of other intiatives that aim to further secure the supply chain and prevent the release of counterfeit drugs.
For instance, the directive will integrate a new barcode system on all treatment packs that will allow pharmacies to ensure their product is coming from the actual manufacturer or authorized supplier. The system will be created by a delegated act adopted by the European Commission.
Beginning in July, API manufacturers and importers outside of the EU will also need written confirmation that their product has been created under GMP standards equivalent to those in the EU.
China and India are still struggling in setting up their systems under which API manufacturers will obtain such approval.