Within the variation notification a letter/cover letter can be uploaded under the tab "Send/Submit".

Because there is not separate upload area, all the available options for upload for each SKNR can be utilised. If the data files still to be submitted are not covered by the remaining “free” upload fields, data can still be uploaded under the categories (e.g. a file can be uploaded as a clean version even though it is not actually a clean version). We also recommend that various files be conflated into one file (e.g.: different modules. It should be noted that the total size of uploaded files may not exceed 10 MB. Freely selectable upload options are planned for the future.

The Electronic Variation Notifications manual is available from the PharmNet.Bund portal along with instructions on registration and a form for contacting the Helpdesk.

If you have already applied for a new PNR from us, please contact: partnerinformationen@bfarm.de If the BfArM does not yet know the new marketing authorisation holder/manufacturer, please send a copy of the extract from the commercial register to the above-mentioned e-mail-address.

You can search by notification number, title, ENR, drug name or send date. The search can be masked both front and end via a question mark. With an end masking, a "?" is set at the end of the entered numerical sequence. In front masking, a "?" is set at the beginning of the numerical sequence. With front end masking, a sequence of numbers is bracketed by two "?". When searching for a transmission date, this is entered into the search field with "yyyyy-mm-dd" or "dd.mm.yyyy" and the search is started. In the date search, you can only mask in the search with "equal sign" and in combination with the line notation "yyyy-mm-dd".

The subject line of electronic change notices differs from the subject line of conventionally submitted notifications. Among other things, the drug name (or the first 10 characters thereof) is ONLY included in the subject line of electronical submitted variation notifications. For conventionally submitted variation notifications, the drug name is not listed in the subject line.

If you want to delete an notification that has already been sent, you can submit a deletion request in the same way as a correction request. However, this only applies as long as the display has only been sent but not yet processed by the BOB. To do this, select the desired change notification in the worklist under "List sent notifications" and select the option "Request deletion".

If it is no longer possible to delete the display because processing by the BOB has already started, the following message appears immediately: Deletion is no longer possible for the selected notification.

In the current stage of expansion, the use is suitable in cases where company-specific changes has to be submitted that do not require an individual document upload.

Yes. If the notification has not yet been submitted to the NCA, documents can be deleted from the variation notification/ variation form and these will also be deleted in file form from the PharmNet.Bund server. NCA employees have no access to the data of the particular variation notification/ variation until it has actually been submitted to the NCA.

No this facility is not currently available.

If a new, valid PNR is provided in AmAnDa, it is automatically made available in the PharmNet.Bund portal. A PNR is inextricably linked to a pharmaceutical company. A new PNR is issued, for example, after the company has been renamed. These are usually two different legal entities.

As the PNR is linked to the company as described above, the access data is also inseparably linked to the PNR and cannot be transferred to another PNR. In this case we ask you to register the new PNR (which was issued by the BfArM after the name change etc.). If the access data for the former PNR (before the change of name, etc.) is not needed anymore, an authorized user of the application can initiate the deletion of this data..For this purpose, an e-mail can be sent to the contact e-mail address stored in the PharmNet-Bund portal.

The navigation bar on the left contains the Preferences tab. This allows the user to decide whether or not the local path is displayed for the file name during upload.

For variations it is necessary to enter telephone numbers according to the international standard (e.g. +49 228 207-30, i.e. national code, space, location area code without preceding zero, telephone number and, where applicable, the extension).

The optimal font size has not been set for the browser. This can be done in the browser by using the menu View -> Font Size. Recommended: medium or small.

A variation notification/ variation that is being processed will be blocked for a given day, if an authorised user has incorrectly initiated the variation notification/ variation or has “crashed”. With a renewed attempt to call up the variation notification/ variation, the user will see an automatic system message saying that the document is being processed. The data can be accessed as usual on the next day. The basic problem is the use of the browser. Only in exceptional cases should several windows be opened simultaneously for one browser. It is recommended that two different browsers are used (e.g. Internet Explorer + Firefox).

The left navigation bar contains the Preferences tab. This can be used to preset the number of electronic Variation notifications currently in process displayed in the list.

Registration can only be performed properly if pop-ups are allowed. The registration tool is a self-contained application and is not part of the Electronic Variation Notifications product.

To enable the Electronic Variation Notifications application to function properly, it is imperative that all pop-up blockers are deactivated. All deletions have to be confirmed in an additional dialog step. If pop-up blockers are active data may not be properly deleted because the deletion could not be confirmed.

It is probably a consequence - SKNR, which cannot be eliminated. If a sequence - SKNR does not apply, please tick "SKNR not relevant for this advertisement". Since this field is not offered for all sequence SKNR, you can alternatively note in the comment field or in the fields "present" and "proposed" that the SKNR is not relevant for the change display. In the case of processing by our employees, this fact of change will not be taken into account. With one of the next updates of the application we will offer the possibility of deselecting sequence - SKNR.

With regard to various structure numbers uploads are possible in PDF file format (up to 10 MB). We request that data not available in this format be sent using the Common EU Submission Platform (CESP) or on CD-ROM. Other methods for submitting data will be made available in subsequent development phases of the Electronic Variation notification application.

Currently it is not possible to insert a letter head or a company logo in the notification form or to perform reformats in the form. Users do have the option, however, of attaching a separate document containing the company logo etc. A standard upload function (e.g. Annex) can be used for this purpose.

To be able to generate the final form without any problems, the following Internet Explorer settings may NOT be selected: Extras- Internet options - Enhanced - Security - Encrypted pages may not be stored on the hard drive. As a rule the final form can only be printed out after the Electronic Variation notification or Variation has been sent.

For all variations submitted after 20.04.2007, the pharmaceutical company will receive a status e-mail in its electronic mailbox.