In Austria, the supply chain for medicinal products is as follows: pharmaceutical companies – pharmaceutical wholesalers – persons authorised to dispense medicinal products – patients. Pharmaceutical companies can mean manufacturers, marketing authorisation holders or national distribution companies. Persons authorised to dispense medicinal products may refer to public pharmacies, hospital pharmacies or dispensing doctors. Under the Falsified Medicines Directive, the members of this supply chain have the following tasks:
The EU Directive 2011/62 and the Delegated Regulation EU 2016/161 obligate all manufacturers of prescription-only medicinal products to equip them with safety features so that wholesalers and persons authorised to dispense medicinal products are able to verify the authenticity of the product and to identify individual packs.
This is ensured by means of a randomised unique serial number which, together with its batch number and expiry date, is encoded in a two-dimensional barcode. For coding requirements please see the AMVO Coding Rules.
The manufacturers upload all medicinal product data to the so called “European hub”, which is operated by EMVO (European Medicines Verification Organisation), an organisation founded by the European associations. The uploaded information is then distributed to the individual national systems.
The legal entity connected to the European hub is referred to as OBP (Onboarding Partner). EMVO has decided to allow only one Onboarding Partner per group of companies. The Onboarding Partner has to upload packaging information for all marketing authorisation holders which are part of its group of companies.
Companies that operate throughout Europe and are also present on the Austrian market will thus mostly handle the onboarding process through their European headquarters. If, however, a company has its headquarters in Austria, it is very likely that the onboarding will take place there. It is advisable to check the internal processes within the company as soon as possible.
For further information regarding the onboarding process as well as a video tutorial please follow this link to the EMVO website (section videos).
The national sales organisations of pharmaceutical companies in Austria must ensure that their packaging information can be processed by the Austrian system.
In order to comply with applicable legal requirements according delegated regulation, all pharmaceutical wholesalers have to connect to the national database system of the country in which they operate. In defined cases, for instance, purchase from another wholesaler, returned products, suspected tampering with packaging or product falsification, the wholesaler must check and decommission the serial number of the medicinal product pack.
National law may also obligate wholesalers to decommission serial numbers if they deliver medicinal products to recipients who do not have direct access to the national repository (e.g., prisons, veterinarians or rescue organisations). A national regulation with regard to the above is being prepared.
1,352 public pharmacies (status as at 31 December 2016, source: Apotheke in Zahlen) supply the Austrian population with medicinal products.
They play an important role in implementing the legal requirements for the serialisation and verification of medicinal products. Each medicinal product pack equipped with safety features must be checked before being handed out to the patient. During the verification procedure the pharmacist checks the anti-tampering device on the packaging and scans the 2D code in order to compare the serial number contained in the barcode with the serial numbers stored in the national repository. If the relevant serial number appears in the national repository, the pack can be handed out to the patient and is then labelled as dispensed in the system. Consequently, a medicinal product with the same serial number cannot be dispensed a second time.
43 out of 274 hospitals in Austria operate a hospital pharmacy (status as at 31 December 2016, source: Apotheke in Zahlen).
While public pharmacies are obligated to verify and decommission the serial numbers of medicinal products when handing them out to a patient, healthcare institutions are free to complete this process according to the delegated regulation at any time the medicinal products are in the physical possession of the healthcare institution. The goal is to seamlessly integrate these requirements into healthcare institutions.
Some 840 physicians in rural areas in Austria dispense medicinal products themselves.
They are subject to the same legal requirements with respect to verifying and decommissioning serial numbers as public pharmacies.