Service Finder
Submit product information texts
Service Description
Consumers must be able to find product information texts, i.e. the package leaflets and specialist information for medicines, online. The Federal Institute for Drugs and Medical Devices (BfArM) regularly makes the product information texts available online for this purpose.
As a pharmaceutical company, you must submit your final product information texts to the BfArM once the procedure has been completed. This also applies to regulatory changes to the texts.
You can only submit the texts online via the specialist application PIT. In addition to the mandatory German versions, you can also upload English versions.
Process flow
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.
Requirements
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.
Which documents are required?
- Final product information texts in German and, if necessary, also in English
What are the fees?
There are no additional fees for submitting texts and using the specialist application.
What deadlines do I have to pay attention to?
You must upload the texts within 3 weeks of completing a regulatory activity (new authorization, variation, renewal; English text version).
Processing duration
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.
Legal basis
Applications / forms
The submission of product information texts is not an application procedure subject to appeal. Submission is the responsibility of the applicant.
Appeal
- Forms: yes
- Online procedure possible: yes
- Written form required: no
- Personal appearance required: no
Further Information
- Portal for drug information of the federal and state governments (online platform PharmNet.Bund)
- Information on product information texts on the portal for drug information of the federal and state governments (online platform PharmNet.Bund)
- Instructions for the specialist application Product Information Texts (PIT) on the portal for medicinal product information of the federal and state governments (online platform PharmNet.Bund)
Author
The text was automatically translated based on the German content.
- Product information texts after completion of the process Publication
Remark: Display of performance in the source portal
Technically approved by
Federal Ministry of Health
Professionally released on
21.07.2021
Source: Zuständigkeitsfinder Thüringen (Linie6Plus)
Competent Authority
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Address
53175 Bonn, Stadt
Remark: Bonn office
Link to the directions:
https://www.bfarm.de/DE/Das-BfArM/Anfahrt/_artikel.html
