1. Scope of services

The higher federal authorities, the BfArM, the PEI and the BVL (hereinafter referred to as BOB) provide pharmaceutical companies with portal applications via the Internet portal PharmNet.Bund.de, which can be used to create, record and transmit applications, notifications, objections or other reports on various technical procedures to the respective higher federal authority.

2. Authorised users

Authorised users are those persons registered with the BfArM who fulfil the requirements of the respective portal application. Information on the central registration procedure and the registration requirements can be found at the BfArM under the respective portal entrances of the applications at www.pharmnet-bund.de or in the service area under access and user administration.

3. Use of data from the higher federal authorities

For the preparation of applications, notifications, submissions or other communications, the necessary electronically available information on marketing authorisation holders and their medicinal products is made available via the specialised application. The information may also contain trade and business secrets.

4. Processing of applications via the specialised application

The BOB shall process the applications, notifications, submissions or other communications submitted via the specialised application as part of the normal workflow. The submissions are deemed to have been received when the applications, notifications, submissions or other communications have been sent electronically to the BOB. This will normally occur within a few minutes of the user's successful submission from the specialist application.

5. Costs

There are no additional costs associated with the processing and publication of filings created and submitted via the specialist application. These are already covered by the fee for the basic procedure.

6. Blocking of online access

Online access will be blocked immediately in the event of suspected misuse and/or at the request of the authorisation holder.

7. Users' duties of care and cooperation

a. Confidentiality of User ID and Password

Users must ensure that no unauthorised person obtains knowledge of their access data. In particular, the access data must not be stored unprotected on a computer. Anyone who gains access to the access data will be able to use the online service. If users discover that an unauthorised person has obtained their access data, they must immediately change their password or have their access blocked. If this is not possible, they must immediately inform the competent higher federal authority.

b. Protection of the user system

Since attacks on the security of the online system are possible, users must, in their own interest, take the necessary measures to avert these dangers and keep their computers free of all programmes that could endanger security (e.g. computer viruses and so-called Trojan horses). Various commercially available anti-virus programs and their updates can assist them in this. Users must ensure that the browser they use is free from security vulnerabilities and regularly check the security of the system they are using (operating system, browser, etc.) in order to prevent the online system from being compromised. The user must take measures to increase the security of the system, e.g. by installing programme updates for security purposes.

c. Due diligence during the transaction

When the welcome screen of the PharmNet.Bund.de Internet portal and the online applications appear, users must first check the certification of the online address to ensure that they are actually in contact with PharmNet.Bund.de. Otherwise, there is a risk that third parties may obtain knowledge of the user ID and password in this way. Users must ensure that all the information they enter is complete and correct. Incorrect information can have a direct impact on the content of the marketing authorisation.

8. Duties of care and cooperation of the marketing authorisation holder

The marketing authorisation holder shall ensure that the authorised representatives of the marketing authorisation holder to whom the marketing authorisation holder intends to transfer the use of the online procedure are made aware of the duties of care and cooperation of the users referred to in point 7. The marketing authorisation holder himself is subject to the same duties of care and cooperation as the authorised users.

9. Liability

The disclaimer published at www.pharmnet-bund.de applies.

10. Withdrawal or amendment of submissions

Submissions may only be withdrawn or amended outside the online procedure, unless the BOB expressly provides for this possibility within the procedure.