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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 by the company administrator in the RuBen application (registration and user administration) for the PIT specialist procedure. 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. The applicant is responsible for the submission.

Appeal

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

Further Information

Author

Forwarding service: Deep link to the original portal

The text was automatically translated based on the German content.

Technically approved by

Federal Ministry of Health

Professionally released on

21.07.2021

Source: Zuständigkeitsfinder Thüringen (Linie6Plus)

No competent authority found

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