Information about the AMIS overall replacement

The Medicinal Product Information System (AMIS) has been used for many years. Due to technical progress and insufficient assurance of functionality for the future, AMIS will be replaced by the successor database AmAnDa. This process has been prepared intensively and is very complex. A timely completion of the replacement is planned, but the availability of sub-functions or special applications may be limited in time beyond the transitional period. We are pursuing the goal of minimizing these restrictions as far as possible.
The conversion of the previous Federal Medicinal Product Information System AMIS to the successor database AmAnDa and the associated additional applications is planned for 19/03/2020. The higher federal authorities BfArM, PEI and BVL as well as DIMDI are affected by the conversion. During a transitional period, various special applications will be temporarily unavailable or will only be available with the database of 19/3/2020, while individual special applications will be switched off before this date. We will provide regular updates on the progress of the conversion.
The first step will be to convert the internal databases for the higher federal authorities. The medicinal product data of the AMIS database will be frozen to the status of 19/03/2020. From 23/03/2020 the successor database AmAnDa will be the leading system.

What does this mean for pharmaceutical companies?

1. Shutdown of the online portals and other specia applications
   In order to ensure that all data and documents submitted via the portals can still be transferred and migrated correctly, it is necessary to switch off the portals at an earlier time. The concrete dates for shutdown are as follows:

   1. Electronic variation notifications: 13/03/2020 at 5.30 pm
   2. Electronic standard marketing authorizations: 13/03/2020 at 5.30 pm
   3. Sunset-Clause: 17/03/2020 at 5.30 pm
   4. Submission of the informative texts after the approval of regulatory procedures via the AMG submission ordinance: 17/03/2020 at 5.30 pm
2. The special applications electronic variation notifications and electronic standard marketing authorizations will be available again after a transitional period.
   
3. The special application "Sunset-Clause" and the electronic procedure for the submission of informative texts after completion of the procedure will be replaced by new maintenance applications in the PharmNet.Bund portal.
   

4. If the release process of the specialized applications is delayed for a longer period of time, the notifications and notifications can be made at a later date in deviation from existing deadlines.

   The BfArM expressly requests that this option be used. This does not result in disadvantages or additional costs for the marketing authorisation holder. The recommended procedure is as follows:

   1. Submissions should be made as soon as the online applications are available again.
   2. The date of receipt of subsequent submissions will be set to the date of the planned submission retroactively. The earliest possible date for retroactive effect is 13.03.2020.
   3. Due to the described procedure, the deadlines are considered to be met. This applies in particular to the Sunset Clause notifications

5. Submissions via the following procedures are not affected by the transitional period:

   1. Procedure according to §42b AMG
   2. Notification of supply shortages
6. The existing public part of AMIS will be replaced by a new medicinal product fact database (AM-FDB) and a new search interface AMIce.
   
7. Data quality:
   Due to the complex changes in the data model, it cannot be excluded that the database may contain so-called migration errors. These will be corrected with top priority. If errors are detected by the marketing authorisation holders, please report them to the following e-mail address: amanda-support@bfarm.de
   

8. Authentication and registration for use of the new special applications:
   There is a role-based central authentication and registration for access to the new special applications via the RuBen application. Information on the certificate, setting up access and user administration can be found under user authorisation.
   Specialized applications, for which a certificate is required due to the high protection requirements, are
   • Electronic Variation notifications
   • Sunset Clause
   • in the future the specialist application for Supply shortages