The medicines supply chain

In Austria, the supply chain for medicinal products is as follows: pharmaceutical companies – medicinal product wholesalers – persons or entities authorised to dispense medicinal products – patients. Pharmaceutical companies can mean both manufacturers and national distribution companies. Persons or entities authorised to dispense medicinal products may refer to public pharmacies, hospital pharmacies or self-dispensing doctors. Under the Falsified Medicines Directive, the members of this supply chain are in charge of following tasks:

EU Directive 2011/62 and Delegated Regulation EU 2016/161 obligate all manufacturers to equip prescription-only medicinal products with safety features so that wholesalers, pharmacists and other persons involved will be 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. The barcode is placed on the packaging by the manufacturer and stored in a database.

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 national sales organisations of pharmaceutical companies in Austria must ensure that their packaging information can be processed by the Austrian system.

In Austria, AMVO has contracted into setting up the national database system. Within AMVO, the pharmaceutical companies are represented by PHARMIG and Österreichischer Generikaverband (Austrian Generic Medicines Association). AMVS GmbH, a 100% subsidiary of AMVO, is responsible for the technical operation of the national system. This is where pharmaceutical companies can obtain all the information on participation in the Austrian system.

AMVS website

In order to comply with applicable legal requirements, all medicinal products 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 the serial number of the medicinal product pack.

AMVO (Austrian Medicines Verification Organisation) was founded in order to implement the national verification system for medicinal products. Its members are PHAGO, PHARMIG (Association of the Austrian Pharmaceutical Industry), Österreichischer Generikaverband (Austrian Generic Medicines Association) as well as the Austrian Chamber of Pharmacists and the Austrian Medical Chamber.

AMVS GmbH, a 100% subsidiary of AMVO, is responsible for the technical operation of the national system. This is where medicinal products wholesalers can obtain all the information on participation in the Austrian system.

AMVS website

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 bearing safety features must be verified before being handed out to a patient. To do so, the pharmacist scans the 2D code on the packaging, comparing 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 or “decommissioned” in the system. Consequently, a medicinal product with the same serial number cannot be dispensed a second time.

In Austria, AMVO has contracted into setting up the national database system. Within AMVO, employed and self-employed pharmacists working in public pharmacies are represented by the Austrian Chamber of Pharmacists.

AMVS GmbH, a 100% subsidiary of AMVO, is responsible for the technical operation of the national system.

AMVS website

Some 840 general practitioners 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.

In Austria, AMVO has contracted into setting up the national database system. Within AMVO, self-dispensing doctors are represented by the Austrian Medical Chamber.

AMVS GmbH, a 100% subsidiary of AMVO, is responsible for the technical operation of the national system. This is where self-dispensing doctors can obtain all the information on participation in the Austrian system.

AMVS website

43 out of 274 hospitals in Austria operate a hospital pharmacy (status as at 31 December 2016, source: Apotheke in Zahlen).

When it comes to serial number verification, hospital pharmacies enjoy greater flexibility than public pharmacies. While public pharmacies are obligated to verify and decommission the serial numbers of medicinal products when handing them out to a patient, hospital pharmacies are free to complete this process at any time after receipt of the goods. The goal is to seamlessly integrate these requirements into hospital routines.

In Austria, AMVO has contracted into establishing the national database system. Within AMVO, pharmacists employed in hospital pharmacies are represented by the Austrian Chamber of Pharmacists.

 AMVS GmbH, a 100% subsidiary of AMVO, is responsible for the technical operation of the national system. This is where hospital pharmacies can obtain all the information on participation in the Austrian system.

AMVS website