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
Consumers must be able to find product information texts, i.e. the package inserts 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 submit the texts exclusively online via the PIT specialist application. In addition to the mandatory German versions, you can also upload English versions.
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
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Required Documents
- finale Produktinformationstexte in deutscher und gegebenenfalls zusätzlich in englischer Sprache
Remedy
The submission of product information texts is not an appealable application procedure. The applicant is responsible for its own submission.
Links to more information
Status:23.06.2022
Responsible for editing:Bundesministerium für Gesundheit
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