Agreement between Austria and Liechtenstein
As of 01.12.2010, the agreement between the Republic of Austria and the Government of the Principality of Liechtenstein concerning the automatic recognition in Liechtenstein of human and veterinary medicinal products authorized or registered in Austria enters into force.
It regulates the procedure of recognition, technical cooperation as well as cooperation in the field of pharmacovigilance and market surveillance. Based on the agreement, marketing authorizations granted by AGES PharmMed/BASG within the framework of the mutual recognition procedure or decentralized procedure (MRP/DCP) will automatically be valid in Liechtenstein, provided that the applicant explicitly applies for this.
What does this mean for the pharmaceutical industry?
Applicants who wish to include Liechtenstein as a Concerned Member State (CMS) in an MRP/DCP procedure can submit the application directly to the BASG as of 15.12.2010 if Austria is involved in an MRP/DCP procedure as a Reference Member State (RMS) or CMS.
All registration documents must be sent to the Austrian Federal Office for Safety in Health Care. The Liechtenstein authority Amt für Gesundheit, Aeulestrasse 51, 9490 Vaduz, must be informed that a procedure is being requested. Time slots from Austria must be taken into account.
The evaluation of the submitted dossier is carried out by the Austrian authority according to the provisions of EEA law. The marketing authorization date of the drug in Austria is also considered the marketing authorization date in Liechtenstein under EEA law, and is used as the reference drug for data protection periods. The Austrian marketing authorization number and the respective Austrian version of the texts for expert information, patient information, labeling and labeling apply. Subsequently, the entire lifecycle management of the affected medicinal product will be handled via Austria. For the Sunset Clause regulation, the data of the medicinal products on the Austrian market will be used.
The medicinal products recognized in Liechtenstein will be published in Liechtenstein.
Market surveillance, inspections and pharmacovigilance
The tasks of market surveillance and inspections in Liechtenstein are carried out by the Liechtenstein Office of Public Health, while the tasks of pharmacovigilance are divided between the Austrian and Liechtenstein authorities in accordance with the agreement. Reports of suspected adverse drug reactions occurring in Liechtenstein will continue to be made to the Office of Public Health or directly to the European Medicines Agency (EMA).
Authorizations via the customs treaty will not be affected by this agreement. This means that marketing authorizations granted by Swissmedic, the Swiss Agency for Therapeutic Products, under the customs treaty between Switzerland and Liechtenstein are not affected by the Austria-Liechtenstein agreement. Medicinal products authorized by Swissmedic and medicinal products authorized by the Austrian authority in accordance with the agreement with Liechtenstein can therefore be found side by side on the Liechtenstein market.
Further inquiries:
AGES PharmMedInstitute Marketing Authorization & Lifecycle Management
DI Dr. Christa Wirthumer-Hoche
Phone: +43 (05)50 555-36500
E-mail: c hrista.wirthumer-hoche@ages.at
