Key deliverable of Falsified Medicines Directive achieved
The European Medicines Agency has upgraded its EudraGMP database so that it now contains information on good distribution practice (GDP) in addition to good manufacturing practice (GMP).
The new database, now called EudraGMDP, is a key deliverable of the new European Falsified Medicines Directive, which came into force in January 2013. It will make the supervision of manufacturing and distribution of medicines more robust by allowing all the actors in the supply chain to check information available on their suppliers.
EudraGMDP will be gradually updated by medicines regulatory authorities in European Union (EU) Member States with distribution-related information and maintained on an ongoing basis. The additional information will include:
- wholesale distribution authorisations;
- GDP certificates;
- statements of non-compliance with GDP;
- registrations of manufacturers, importers (including information on their suppliers) and distributors of active substances.
EudraGMDP is a modification of the EudraGMP database, which was launched in April 2007 to facilitate the exchange of information on compliance and non-compliance with GMP among the regulatory authorities within the European medicines network.
The new system follows the introduction of a new module on planning GMP inspections in countries outside of the EU in December 2012. This module, which is not publicly accessible, was developed in order to make better use of inspection resources by sharing of information among EU regulators and avoiding redundant inspections.
The public has access to most information contained in EudraGMDP, and even more information will be accessible in the coming months, including GMP non-compliance statements. Information of a commercially or personally confidential nature is not released to the public. The decision on which information can be made public is made by the medicines regulatory authority in the Member State that uploads the information to the database.
About the Falsified Medicines Directive
In July 2011, the EU strengthened the protection of patients and consumers by adopting a new Directive on falsified medicines for human use.
The Directive aims to strengthen the supervision of the supply chain of medicinal products and active substances, in order to avoid falsified medicines entering the EU market.
The new requirements in the directive can be subdivided in four main pillars:
- Safety features of medicines
The Directive introduces unique identifiers. In practice, these will be barcodes printed or attached to every single pack of medicines subject to prescription and other medicines at risk of being falsified. These safety features will also allow verification that the outer packaging has not been tampered with. The barcodes will be checked into a database repository system by the manufacturer and checked out when dispensed by a pharmacy.
A delegated act, which will be adopted by the European Commission, will detail measures for the implementation of the unique identifiers. This act will in particular determine the governance of the repository system, in which the Agency may be involved.
- Supply chain and GDP
EudraGMDP is part of this second area of change of the Directive. This part of the Directive includes new responsibilities for wholesalers and a definition of brokering activities as well as new responsibilities for brokers. In March 2013, the Agency finalised the revision of its GDP guideline, which is published on the European Commission's website. As required by the Directive, this revision includes specific provisions for brokering activities.
- Active substances and excipients
The new Directive foresees that from 2 July 2013, all active pharmaceutical ingredients manufactured in countries outside the EU and imported into the EU must be accompanied by a written confirmation from the competent authority of the exporting country. These statements will be issued per manufacturing site and per active substance and will ensure standards of GMP equivalent to that in force in the EU with regular inspection by the local authority, and strict enforcement of GMP. A number of countries have already committed to issuing written confirmations.
The Directive also foresees that exporting countries with an equivalent regulatory framework will not need to issue written confirmations. Some countries have applied to be listed as 'equivalent'. The European Commission, together with the Agency and Member States, is assessing their regulatory frameworks.
- Internet sales
The Directive has introduced an obligatory logo that will be placed on the websites of legally operating online pharmacies. This unique, recognisable logo will allow patients and consumers to identify authorised online pharmacies providing authentic authorised medicines. Online pharmacy websites will need to be registered with a Member State and websites of medicines regulatory authorities in Member States will publish the list of authorised internet pharmacies.
The European Medicines Agency, along with the Member States, will play an active role in informing the public of this new logo and the official lists of authorised online pharmacies. Awareness campaigns will start this year.