The regulation on ensuring the supply of medicinal products enters into force as from April 1, 2020

messages in brief | 29/03/2020

Two different shortages catalogues are effective from April 1, 2020:

  1. The "shortages catalogue" - all reported procedures are presented in this common register.
  2. The "catalogue according to the regulation on ensuring the supply of medicinal products" - this register is  restricted to those proprietary medicinal products which have been banned from parallel export after review by the BASG.

Marketing authorisation holders and their authorised representatives have to submit medicine shortages because of the regulation on ensuring the supply of medicinal products, that enters into force as from April 1, 2020, and because of the "Arzneimittelbetriebsordnung 2009". They are now obliged to report any restriction in supply of prescription-only human medicines using the eService "Marketing Authorisation & Lifecycle MP".

The notification of a shortage affecting a veterinary medicinal product and an over-the-counter medicinal product is voluntary, if it is not subject to notification in accordance with the "Arzneimittelbetriebsordnung 2009".

FAQs to the new reporting system and the guidance note is published at the "Guidance Notes".

     

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