Submit product information texts

You must submit product information texts via the specialist application PIT. The specialized application can be found on the portal for drug information of the federal and state governments (online platform PharmNet.Bund).

Proceed as follows:

• To be able to use the PIT application, you must be activated for the PIT specialist procedure by the company administrator in the RuBen application (registration and user administration). Please contact your administrator for this.
• Log in to the specialist application PIT with your access data.
• Select the procedure for which you want to submit texts.
• You can now upload the product information texts.
• The product information texts you upload will be published on the PharmNet.Bund online platform.

You are a pharmaceutical company and have to submit the final texts after approval or regulatory amended product information texts to the BfArM after completion of a procedure.

• Final product information texts in German and, if necessary, also in English

There are no additional fees for submitting texts and using the specialist application.

You must upload the texts within 3 weeks of completing a regulatory activity (new authorization, variation, renewal; English text version).

You must upload the texts within 3 weeks of completing the procedure. The texts are then usually published on the PharmNet.Bund online platform on the same working day.

• § Section 11 (1a) of the German Medicinal Products Act (AMG)
• §Section 11a (3) of the German Medicinal Products Act (AMG)

The submission of product information texts is not an application procedure subject to appeal. The applicant is responsible for the submission.

• Forms: yes
• Online procedure possible: yes
• Written form required: no
• Personal appearance required: no

• Registration for the online platform PharmNet.Bund
• Specialist application PIT for companies

21.07.2021