With application of the new European Veterinary Medicinal Products Regulation (EU) 2019/6, there are innovations for medicinal products for certain pets according to Article 5(6), which were previously not subject to a marketing authorisation requirement according to Section 7(4) AMG. These veterinary medicinal products may now only be marketed in Austria if they have been notified to the BASG with the information required for the Union Product Database (Union Product Database (UPD) - BASG).

The exemption from the marketing authorisation may be granted if the veterinary medicinal product

• is intended for animals which are exclusively kept as pets: aquarium or pond animals, ornamental fish, cage birds, homing pigeons, terrarium animals, small rodents, ferrets and rabbits
• is not to be classified as a prescription-only product in accordance with Article 34 of Regulation (EU) 2019/6
• does not fall under Article 42(2) and (3) of Regulation (EU) 2019/6

Reference to pharmacovigilance obligations

According to Article 2(4) of Regulation (EU) 2019/6, all provisions of Chapter IV Section 5 (Pharmacovigilance) of Regulation (EU) 2019/6 also apply to pet medicinal products exempted from marketing authorisation.

If the requirements for exemption are met, the BASG submits the data to the UPD.

Registration for the notification

To access the eService Portal of the AGES Medicines and Medical Devices Agency, please register under https://kundenregistrierung.basg.gv.at/

The following documents are required:

• Proof of administrator authorization (LoA), please use the following form: Ermächtigung Administrator
• Company proof

Previously registered companies (for other purposes) are already enabled for notification, no further registration is required.

Further details on registration can be found on the BASG website in the section FAQ online Service - BASG.

Notification of a pet product

To notify a pet product in accordance with Article 5(6) of Regulation (EU) 2019/6, log on to https://eservices.basg.gv.at/, select "New application" in the eService under section "Notification of pet products" and fill in the fields provided.

You can find a detailed description under the following link.

Changes to notified veterinary medicinal products

Changes to the information required for the Union Product Database, the labelling or the package leaflet of the veterinary medicinal product must be reported to the BASG without delay.

By selecting a pet product in "Overview pet products", choose the option "Variation of a pet product" via the button "Edit".

For technical questions please contact: basg-eservices@basg.gv.at.

For specialist issues please contact: basg-heve@basg.gv.at