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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.
Online services & Forms
Online services
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PharmNet.Bund - ProduktinformationstexteYou can submit current product information texts online via the specialist application "Product Information Texts" (PIT).
Forms
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Anmeldung für Onlineplattform PharmNet.Bund
This form can be submitted electronically without signature (e.g. via a secure contact form or by e-mail) or in paper form to the responsible authority.
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Fachanwendung PIT für Unternehmen
This form can be submitted electronically without signature (e.g. via a secure contact form or by e-mail) or in paper form to the responsible authority.
Responsible for you
Bundesinstitut für Arzneimittel und Medizinprodukte
Street address
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Postal address
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn
Phone
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Procedure details
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.
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.
Required documents
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Required Documents
- finale Produktinformationstexte in deutscher und gegebenenfalls zusätzlich in englischer Sprache
Proceedings
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:
- In order 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.
Fees
There are no additional fees for submitting texts and using the specialist application.
Deadlines
You must upload the texts within 3 weeks of completing a regulatory activity (new authorization, variation, renewal; English text version).
Processing time
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.
Appeal
The submission of product information texts is not an application procedure subject to appeal. Submission is the responsibility of the applicant.
Related links
Status: 09.03.2025
Editorially responsible for prodecure description: Bundesministerium für Gesundheit
Source:
Federal Portal
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