Marketing authorisation & life-cycle

Regulatory flexibility during the Corona pandemic

In its March 2020 meeting, the CMDh agreed on flexibility with regard to regulatory deadlines as well as the implementation of user tests for human medicinal products. Further information can be found on the website of the CMDh in the press release of the March Meeting, in the "Notice to stakeholders: Questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic" recently published by the EC, HMA and EMA, and in an additional document of the CMDh ("Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis").

If you have any questions, please contact natbasg.gvat.

Furthermore, the EMA website provides an overview of the measures and EMA's involvement in the global fight against SARS-CoV-2.

For the respective informations for veterinary medicinal products please see the CMDv Website under COVID-19 where also the "Notice to stakeholders: Questions and answers on regulatory expectations for Veterinary Medicinal Products during the Covid-19 pandemic" published by the EC, HMA and EMA and the additional document of the CMDv "Practical guidance of the CMDv for facilitating the handling of processes during the COVID-19 crisis" can be found.
An overview of the measures and EMA's involvement in the global fight against SARS-CoV-2 with regard to veterinary medicinal products can be found here on the EMA website.

COVID-19: Marketing of medicinal products whose expiry date has expired

According to AMG § 4 (3) paragraph 2, it is prohibited to place medicinal products on the market whose expiry date has been exceeded. The expiry date is printed to the packaging by the marketing authorisation holder and is based on the shelf life of a medicinal product as approved during the marketing authorisation process.

In the course of the coronavirus pandemic, on the one hand, there may be shortages of critical medicinal products, and on the other hand, medicinal products whose expiry date has passed would have to be destroyed, although they could still be used with good quality.

According to § 1 Abs. 1 der Verordnung des Bundesministers für Soziales, Gesundheit, Pflege und Konsumentenschutz betreffend Sonderregelungen für die Dauer der Pandemie mit COVID-19 iVm § 94d AMG idF BGBl. I Nr. 23/2020 the Marketing Authorisation Holder can apply - under certain conditions - to market medicinal products whose expiry date has expired.

Concrete procedure

1) APPLICATION BY THE MARKETING AUTHORISATION HOLDERS 

The marketing authorisation holder must submit an application by e-mail to natbasg.gvat with the following subject line: "Abgabe nach Verfalldatum name of the medicinal product", providing the following information:

  • Marketing authorisation holder
  • Name of the medicinal product
  • Marketing authorisation number
  • Batch numbers affected
  • Appropriate stability data (if necessary in the form of reference samples, stability data, etc.)
  • Indication of the old expiry date, application, how long marketing is possible (based on data submitted, extension max. 6 months).

Such applications can only be submitted for crucial hospital medicinal products to cope with the corona crisis and only for a limited period of time; no fees are charged. (When in doubt whether a given medicinal product is a crucial medicine for treatment of COVID-19 patients, the MAH may contact BASG using natbasg.gvat).

2) APPROVAL BY BASG

The application is processed by BASG, marketing after expiry date for the respective batches is approved.

3) PUBLICATION BY BASG

Here you will find an overview of those medicines which may be dispensed after the expiry date stated on the packaging. The marketing authorisation holder was able to show with corresponding data that the product quality is maintained. Respective packages (containing the “old” expiry date) may be dispensed after expiry date as long as mentioned in the list above.

Medicinal products may only be dispensed after their expiry date after positive assessment by the BASG, if the pharmacist has documented and proven that he or she is no longer able to acquire regular goods from wholesalers or directly from the marketing authorisation holder.

If you have any questions, please contact natbasg.gvat.

If the marketing authorisation holder is seeking a general extension of the shelf life, a separate application must be submitted in accordance with the Variation Regulation.

Marketing authorisation of medicinal products

Drug authorisation on the basis of the Austrian Drug Law is one of the main tasks of the Federal Office for Safety in Health Care (BASG). During the authorisation process, the experts check the efficacy, safety and quality of the drug. A medicinal product shall only be authorised if the existing risk-benefit profile is proportionate and the benefits outweigh the risks.

An authorisation is initially granted for a period of five years. Afterwards, a new application must be submitted to the BASG, on the basis of which the drug will be re-examined. If the result is positive, the extension takes place. Any changes to medicinal products must also be submitted to the BASG for approval.

 

Authorisation types

There are three marketing authorisation procedures for medicinal products in Europe:

  1. National authorisation procedure
  2. MRP / DCP process
  3. Central authorisation procedure
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