Safety features AMVS
The Background of Serialization in Austria and Europe
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 (AMVO for short), 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. For the establishment and operation of the Austrian data storage and retrieval system (short: "AMVSystem"), the connection to the European data storage and retrieval system as well as the provision of interfaces to the pharmaceutical wholesalers (short: In the year 2017 the AMVS GmbH - Austrian Medicines Verification System GmbH (short: "AMVS GmbH"), a 100% subsidiary of the AMVO, was founded by the AMVS GmbH- Austrian Medicines Verification System GmbH (short: "AMVS GmbH") and the persons authorised or authorised 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, hospitals and pharmaceutical wholesalers to connect their systems with the national AMV data storage system.The AMVS provided detailed documentation and provided information on the necessity and possibilities of connection at numerous events on site. The planned processes for joining the AMVS system 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 9.2.2019 - with stabilisation phase until 9.2.2020
In order to ensure a smooth start and a continued high level of supply, a stabilisation phase began on 09.02.2019. Until February 9, 2020, all persons and organizations involved have 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, the pharmacist, the doctor in charge of the house pharmacy 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" will be 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, more than 120 million drug packages have already been uploaded into the system by drug manufacturers. Around 170 pharmaceutical wholesalers, 1,440 public pharmacies and hospital pharmacies, as well as 840 doctors running GPs and 22 in vitro fertilisation centres are connected to the system and thus guarantee original and effective medicines for patients. Thanks to the excellent cooperation of all participants, the AMVS was able to achieve its project goals and is well prepared for various scenarios and challenges around 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 do not hesitate to contact us at the following e-mail address:
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
Letter to stakeholders regarding the implementation of safety features under the Falsified Medicines Directive 2011/62/EU applicable on 9 February 2019
Has the unique identifier (UI) to be printed on the pack in any case or are the other options possible?
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 email@example.com.