Pharmaceuticals; submission of product information texts

As a pharmaceutical company, you must submit the product information texts to the Federal Institute for Drugs and Medical Devices (BfArM) via a specialist application once the procedure has been completed. The texts will be published.

Description

Prerequisites

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

Procedure

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

To do this, proceed as follows:

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

Deadlines

You must upload the texts within 3 weeks after the completion of a regulatory activity (new approval, amendment, renewal; English text version).

Processing time

You must upload the texts within 3 weeks after completion of the procedure. The publication of the texts on the PharmNet.Bund online platform then usually takes place on the same working day.

Required documents

  • Required document/s

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

Online procedures

Fees

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

Remedy

The submission of product information texts is not an appealable application procedure. The applicant is responsible for its own submission.

Status:23.06.2022

Responsible for editing:Bundesministerium für Gesundheit

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