Legal basis:

§21 section 6 of the Veterinary Medicinal Products Act, as amended (TAMG, https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=20012477) stipulates that the package leaflet must be provided in electronic form or in paper form or in both formats by the Marketing Authorisation Holder.

According to §2 section 3 Vet-Gebrauchsinformations-Verordnung, as amended, (VETGV, https://www.ris.bka.gv.at/GeltendeFassung.wxe?Abfrage=Bundesnormen&Gesetzesnummer=20012823), if the package leaflet is provided electronically, both a code and a URL leading to the relevant package leaflet must be placed on the outer packaging of the veterinary medicinal product.

Practical implementation:

A QR code is usually used today, but other codes that serve the same purpose are also possible. The BASG works with the EMA-CMDv guidance document “Quick Response (QR) codes in the labelling and/or package leaflet of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentralised procedures (DCP) and national procedures”: Product information: Reference documents and guidelines | European Medicines Agency (EMA). The contact points of the authorities and the request form can also be found at this address. 

If it is not possible to apply for the electronic package leaflet as part of an ongoing procedure, a VRA G.I.15.z must be submitted to the BASG via CESP as specified in the aforementioned guidance.

For the additional relevant elements of the code and the URL on the outer packaging, an application in accordance with Art. 13 of Regulation (EU) 2019/6 must always also be submitted to the BASG (informally). 

The website of the marketing authorisation holder on which the electronic package leaflet is stored shall meet the following requirements:

-          Performance of safeguards shall be possible to ensure that the electronic data and content are protected from tampering.

-          Safety and back-up mechanisms in the event of a hardware or software fault are to be implemented. 

-          Protection against hardware and software intrusion shall be ensured.

-          Downtime and display errors are to be reduced as far as possible.

-          The link to the internet address shall be stable and directly accessible at all times. 

Please note that the BASG recommends a step wise approach for the introduction of electronic package leaflets:

Initially, the use of electronic package leaflets should be limited to veterinary medicinal products used by veterinarians. For these veterinary medicinal products, the package leaflet should be made available both electronically and in paper form for a period of 2 years.

Later, electronic package leaflets can also be provided for prescription-only veterinary medicinal products used by animal owners themselves, and finally for over-the-counter veterinary medicinal products. For these veterinary medicinal products, the package leaflet should be made available both electronically and in paper form for a period of 5 years.