Amendments to the AMG (Austrian Medicines Act, Arzneimittelgesetz) concerning notifications of discontinuation of placing on the market
With the AMG amendment of 14.02.2022, § 21(2) was changed to the effect that the BASG must now be notified four months (instead of the previous two months) in advance of a temporary or permanent discontinuation of the marketing of medicinal products.
This notification is to be made (as before) via eService and published by the BASG according to §21(4). Consequently, in the case of a withdrawal of a marketing authorisation/registration, the notification of the final discontinuation of marketing must therefore be made in due time.
A column and a search option have been added to the Register of Medicinal Products (https://aspregister.basg.gv.at). A "JA" ("YES") indication in the column "Einstellung In-Verkehr-Bringen" ("Discontinuation of placing on the market") means that a corresponding notification of a temporary or final discontinuation has been sent to the BASG.
Irrespective of the notification of discontinuation of marketing, in the event of unavailability of a prescription-only medicinal product for human use that is expected to last longer than two weeks or insufficient availability of a prescription-only medicinal product for human use to meet the needs of patients in Austria that is expected to last longer than four weeks, the obligation to notify in accordance with the "Verordnung über die Sicherstellung der Arzneimittelversorgung (BGBl. II Nr. 30/2020)" (Ordinance on the Assurance of the Supply of Medicinal Products (BGBl. II No. 30/2020)) remains in force.