Non-Interventional-Studies NIS

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Important note! New

In accordance with §11 of the NIS MeldeVO, the final report and a lay summary in German should be submitted to the Federal Office via the BASG NIS Register 12 months after the end of the NIS. The NIS Register sends automatic reminders after 12 months. The basis of this reminder is the originally stated planned end of the NIS, not the actual end date.

The NIS Registry is technically unable to take into account updates of the planned end date.

If you receive a reminder and

  • the NIS is not yet completed or
  • less than 12 months have passed since the actual end date,

please consider this letter to be without object.

It is not necessary to obtain additional confirmation from the Federal Office in this case.

General Information

In the amendment to the Austrian Medicines Act, Federal Law Gazette I No. 153/2005 (AMG), Section 48 (3) included an authorization to introduce mandatory reporting of post-marketing surveillance studies and to maintain a corresponding register. With the amendment to the Austrian Medicines Act, Federal Law Gazette I No. 63/2009, the term "Anwendungsbeobachtung" was subsequently replaced by the term "non-interventional study" in view of the terminology commonly used in Europe.

The regulatory authority in Section 48 (3) of the Austrian Medicines Act (AMG) was exercised in the Ordinance on the Conduct of Non-Interventional Studies, which was published in the Federal Law Gazette II No. 180/2010 on 17 June 2010. It stipulates that every non-interventional study that is started from 01.09.2010 onwards must be reported electronically to the Federal Office for Safety in Health Care (BASG) by the person responsible before it is conducted.

Obligation to notify Non-interventional studies are considered to be notifiable if the inclusion of the first patient takes place on or after the date specified in the regulation (01.09.2010). If the first inclusion of a patient occurs before this date, the present regulation does not apply.

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