First registration

There is a role-based, central authentication and registration for the access to applications. The roles differentiate between the administration in the higher federal authorities and the main user in a company.

The administration can provide the main users with rights and activate, deactivate or edit all settings. The main user in a company/authority, can create other users (user) and activate, deactivate and edit them. In doing so, he/she can always only assign one user with a part of his/her own rights.

If other users want to have access to applications, proceed according to the instructions for the selfadministration.

The flow

1. apply for login details
2. fill registration form
3. possibly upload certificate
4. confirm application on confirmation link
5. wait for login details
6. first registration with awarding a personal password

The steps are explained following.

In order to request the access data of a new user, the user must select "Request access data". A registration is an automatic login as main user in a company/authority.

If during the registration applications were chosen that fall into different higher federal authorities responsibility, they must be activated individually by the responsible administrators. A user has e.g. in the registration selected the applications "Batch Release" and "Variation Submission”. Responsible for "Batch Release" is PEI, for "Variation Submission” BfArM is responsible. Competent administrators of the higher federal authorities are notified by mail about the registrations and with this information start the user management. They can assign and activate permissions / roles for applications falling within its competence.

The user who signed up, can already after the first treatment (= activation) use his account for user self-administration and the previously activated applications use even if not all applications "allowed", that is, the associated rollers are awarded.

In the opening form for initial registration, first select the application (s) that you want to use. If available, enter an identification code such as Pharmazeutische Unternehmer-Nummer (PNR) of your company, the MP-Anzeigen Code or the user group and click on "Continue with identification" (otherwise "Continue without identification").

Upon entering an identification code, the address details are already entered into the following form, without the identification code, these details must be typed by him/herself. In any case, the fields such as first name, last name, e-mail address, post code, location and country must be filled out by the user.

In the comments section, messages can be input to the Administration.

If an application requires the 2-factor authentication requires (high protection requirements), the certificate for authentication at this point needs to be uploaded.

The General Terms and Conditions can be viewed via the link and must be accepted by clicking on the subsequent field.

By clicking on "Continue" the user will receive the confirmation of his/her registration in the browser and an e-mail containing a link to confirm your registration.

By clicking on the link "Confirmation" in the e-mail the forwarding to the administration will be initiated. The confirmation link loses after using its validity. If you use it several times, you receive an error message.

A subsequent e-mail "Confirmation of your registration" contains the new customer number.

Once the new user has been activated by the administration, the password and user code will be sent to him/her, in two different ways. The user will receive an e-mail with the preliminary password and will receive the required user code by mail. At the initial login with user code and preliminary password you are prompted to change the preliminary password.

Please note that the registration expires, if within a period of 120 days there is no initial registration.

The user has now acquired the orgaAdmin role.

Contact

Helpdesk Technik
Telephone: +49 (0)228 99 307-4949
E-Mail: helpdesk-technik@bfarm.de