The verification system will help secure the legal supply chain from falsified medicines and detect potential falsifications.
The medicines verification system is a pan-European system which aims to prevent falsified medicines from entering into the legal supply chain and to detect potential falsifications.
The system consists of a central information and data router (designated as “hub” in the Delegated Regulation and as «EU hub» within the context of the Project) and of repositories which serve the territories of each Member State (designated as «national repositories» in the Delegated Regulation and as «national systems» within the context of the project).
The territorial scope of the European medicines verification system is the European Economic Area, composed of the countries belonging to the European Union, plus Iceland, Liechtenstein, Norway and Switzerland.
The EU hub is managed by the European Medicines Verification Organization (EMVO) and each national system is managed by the responsible national organization. An organization counterpart to MVO Portugal has been established in each country involved in the project. The contacts of the different National Medicines Verification Organizations (NMVO) can be found here.
The national medicines verification system is an integral part of the European medicines verification system and consists of the national repository, where the information regarding the packs that circulate in Portuguese territory will be stored. The users of the national system (wholesalers, pharmacies and healthcare institutions) will establish a connection with it in order to be able to execute their obligations of verification and decommissioning of the unique identifier.
Schematically and summarily, the system will operate as follows:
The verification of the authenticity of the medicinal product is performed by comparing the information regarding the unique identifier, registered by the onboarding partner and the information regarding the unique identifier contained in the packaging.
The data regarding each pack will be uploaded to the system by the onboarding partner (the entity responsible before EMVO for uploading the data) through the EU Hub. In turn, the EU Hub will forward the data, in automated form, to the relevant national systems, where it will reside. The users (wholesalers, pharmacies and healthcare institutions), through the connection established for that purpose, will scan the unique identifier placed on the pack in order to compare it with the information contained in the national repository.
The verification of the anti-tampering device is performed by means of visual inspection and, therefore, without resorting to the system.