Within the framework of the EU Directive 2011/62/EU on the prevention of counterfeiting in the legal supply chain and its Delegate Regulation (EU) 2016/161, a data storage and retrieval system must be set up in all Member States to enable the verification of medicines when they are supplied to patients from 9 February 2019. This data storage and retrieval system is to be set up and operated by the pharmaceutical industry in accordance with the legal framework and with the involvement of supply chain stakeholders. 

In 2016, the stakeholders Pharmig - Association of the Austrian Pharmaceutical Industry, Austrian Generics Association OeGV, PHAGO (Association of Austrian Pharmaceutical Wholesalers) and the Austrian Chamber of Pharmacists jointly founded AMVO - Austrian Association for the Implementation of the Verification of Medicinal Products (short: “AMVO”), to which the Austrian Medical Association joined in 2017. The Supervisory and Monitoring Committee of the AMVO is staffed by the member organisations with the involvement of the Ministry of Health and the Federal Office for Safety in Health Care (BASG). The Supervisory and Control Advisory Board of AMVO exercises the supervisory and control powers over compliance with the applicable legal framework conditions for the operating company. AMVS GmbH - Austrian Medicines Verification System GmbH (short: "AMVS GmbH"), a 100% subsidiary of AMVO, was founded at the beginning of 2017 to set up and operate the Austrian data storage and retrieval system (short: “AMVS”), connect to the European data storage and retrieval system and provide interfaces to medicinal product wholesalers (short: “wholesalers”) and persons entitled to supply medicinal products to the public (short: “persons entitled to supply”).

Implementation of serialization

In addition to other stakeholders (manufacturers and wholesalers), the persons authorised to supply pharmaceutical products play an important role in the pharmaceutical supply chain in implementing and complying with legal requirements. Every package of a medicinal product with safety features must be checked before it is delivered to the patient. The person entitled to dispense checks the manipulation protection on the drug package and scans the DataMatrix code, whereby the serial number contained therein is compared with the serial numbers stored in the national data memory. 

In order to comply with the legal obligations of the Directive and the Delegate Ordinance, the technical conditions were created in 2017/18 for public pharmacies, medical home pharmacies, hospital pharmacies and pharmaceutical wholesalers to connect their systems with the national AMV data storage system.

The AMVS provided detailed documentation and information on the necessity and possibilities of connection at numerous events on site. The planned processes for joining the AMVS were completed in good time with all affected parties. Among other things, applications, user contracts and access data were necessary in order to activate all the dispensing offices and thus continue to ensure authorisation to supply prescription medicines.

Full operation from 9 February 2019 - with stabilisation phase until 9 February 2020

In order to ensure a smooth start and a continued high level of supply, a stabilisation phase began on 9 February 2019. Until 9 February 2020, all persons and organizations involved had the opportunity to detect and eliminate any process and application errors and to correct them during the stabilization phase: If the message "Stabilization phase - System check - VAS checks drug package" appears during the scanning process, the pharmacist or the doctor in charge of the house pharmacy must carry out a check for authenticity and integrity as before. If the medicine package is apparently in order, the pharmacist decides as before on the delivery and the business case can be concluded. 

During the stabilisation phase until 9 February 2020, all "system verification notifications" have been analysed by the AMVS together with the marketing authorisation holders. But AMVS, which operates the national data storage of the digital security system, is also available as a reliable service partner for all questions relating to the connection to the digital system. 

Austria is Europe's leading provider of connections to the new digital system as well as for ongoing system operation. In Austria, there are already more than 1441 million medicinal product packages in the Austrian system as of 7 January 2025. 

Start phase live operation from 9 February 2020

The stabilisation phase ended on 9 February 2020 and the AMVS start phase live operation started. During this phase, all stakeholders should be given the opportunity to optimise their processes to ensure that live operation runs smoothly. As of 17 June 2024, the error rate was between 0.0-0.1%. This makes it possible to continue to ensure the high standard of medicinal product supply in Austria.

There are end user contracts with 112 pharmaceutical wholesalers, 1,431 public pharmacies, 25 hospital pharmacies and 809 physicians in charge of in-house pharmacies, which are linked to 2,614 locations and thus ensure original and effective medicines for patients (as of 17 June 2024).

The transition of pharmaceutical supply into the digital age is highly complex and also involved a number of changes and adaptations by the project partners during the stabilisation and start phase of live operation. Thanks to the excellent cooperation of all participants, AMVS GmbH was able to achieve its project goals and is well prepared for various scenarios and challenges associated with the Europe-wide launch of the new system in Austria.

Further information and guidelines can be found on the AMVS website. 

If you have any questions, please contact AMVS GmbH at the following address:

office@amvs-medicines.at
AMVS - Austrian Medicines Verification System GmbH
Square One, Leopold-Ungar-Platz 2, Stiege 1, Top 134, 1190 Vienna
Tel.: +43 1 996 94 99 - 0

www.amvs-medicines.at

In principle YES, the 'unique identifier' has to be printed on the pack. According to QUESTIONS AND ANSWERS 2.21 of the European Commission on the implementation of the Falsified Medicines Directive 2011/62/EU and the Delegated Regulation 2016/161/EU the UI can be placed on the packs by means of stickers under certain exceptional circumstances. In Austria this is regulated by § 3a of the Regulation on Arzneimittelbetriebsordnung 2009 (AMBO 2009) and applications have to be submitted to the Federal Office for Safety in Health Care using the form below.
In case of existing MRP/DCP and national medicinal products the application has to be transmitted via CESP, in case of centrally authorised medicinal products an email with subject „application for § 3a AMBO 2009“ should be forwarded to cp@basg.gv.at.