Implementation status in Austria
Veterinary Medicinal Products Act (TAMG)
The Federal Ministry of Social Affairs, Health, Care and Consumer Protection is currently working on a national Veterinary Medicinal Products Act, which will define the implementing provisions and possible supplements at national level.
The aim is a uniform Veterinary Medicinal Products Act, which contains both the provisions for authorisation (previously Medicinal Products Act AMG) and for use (previously Veterinary Medicinal Products Control Act TAKG).
Until the entry into force of this implementing law, the directly applicable provisions of the EU Regulation are to be enforced within the framework of the existing laws.
With regard to the procedure for the conversion of products authorised in accordance with Directive 2001/82/EC whose renewal submission date falls after 28 Jan. 2022, it is planned to draft a legal regulation in such a way that these products are transferred to an unlimited authorisation.
In the new QRD template (v9), the prescription status is only required in the SmPC (10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS) and the product information leaflet (13.), but no longer in the labelling.
However, if the applicant sees the inclusion of the prescription status as expedient, the application for inclusion can be made nationally in accordance with Article 13 of the Veterinary Medicinal Products Regulation (EU) 2019/6.
Appropriate justification must be attached to the application.
Further information on the can be found at: https://www.basg.gv.at/en/companies/marketing-authorisation-life-cycle/marketing-authorisation-procedure/addictive-drugs-prescription/prescription-of-medicines
The updated fee schedule has been published here: www.basg.gv.at/ueber-uns/gebuehrentarif.
In addition to new fees for veterinary clinical trials, reduced fees have been introduced for marketing authorisation applications for limited markets and under exceptional circumstances in accordance with Articles 23 and 25 of Regulation (EU) 2019/6. The previous veterinary reductions remain in place.
BASG talk NVR
BASG offered a BASG talk (BASG-Gespräch) on the New Veterinary Medicines Regulation on 8 Nov. 2022, and the programme and slides have been filed here: https://akademie.ages.at/basg-gespraech_nvr__die_neue_veterinaergesetzgebung/programm.html