All pharmaceutical companies responsible for distributing products subject to serialisation in Austria must register with AMVS GmbH and conclude an agreement for the use of the system. By doing so, they undertake to contribute to the funding of the national verification system by paying an one-off accession fee and an ongoing annual service fee.
The pharmaceutical companies responsible for the financing of the Austrian repositories system are the pharmaceutical companies included in the list of products of Österreichischer Apotheker-Verlag as manufacturers with a manufacturer code.
By closely cooperating with market authorisation holders and manufacturers, responsible pharmaceutical companies in Austria should support the implementation of the system and keep up to date with the latest development so as to be ready for participation in the national system in due time. They should also find out who the Onboarding Partner of the European Medicines Verification Organisation (EMVO) is with regard to their respective products, to ensure that these products can be uploaded to the European system via the European hub and then forwarded to the Austrian repository.
All companies are strongly advised to start the onboarding process at the European hub as soon as possible by contacting EMVO. Given that the onboarding process takes some time, it is important to start the process even if the particular company is not yet ready to launch serialised products.
To visit the EMVO Onboarding Portal and to obtain further information about the onboarding process as well as a video tutorial, please follow this link to the EMVO website (section videos).
For information on participation in the Austrian system please contact firstname.lastname@example.org.
While the data from the pharmaceutical industry is uploaded to the system via the European hub, all other parties in the supply chain are connected directly to the national systems.
All Austrian companies authorised to act as wholesalers of medicinal products that perform actions according to the delegated regulation in Austria must connect to the national repository. Likewise, all public pharmacies, hospital pharmacies and dispensing doctors must connect to the Austrian system in order to be able to comply with applicable legal requirements.
To be able to participate in the national system, it is first of all necessary to adapt the software to enable linking up with the repository.
To do this, wholesalers and dispensing persons should take the following steps:
For further technical information about the connection to the verification system, software suppliers of wholesalers and dispensing persons must register at Arvato Systems’ SWS portal.
Wholesalers and dispensing persons may contact email@example.com to obtain further information on participation in the system.
This time schedule reflects the current state of knowledge and is subject to changes.