Pursuant to Sections 11 sub-section 1a, 11a sub-section 3 of the Medicinal Products Act (AMG), the submission of the current product information texts (Summary of Product Characteristics (SmPC) and Package Leaflet (PIL) is required. These current text versions are made available to the public in electronic form in accordance with Section 34 AMG. The texts have to be submitted via the application "Product information texts" (PIT). These texts are the last approved text version of the instructions for use and expert information after the positive completion of the last text-relevant regulatory activity.

In addition to the mandatory German-language versions, there is also the option to upload the associated confirmed English text versions.

The "Product information texts" application replaces the previous submission process by email using the so-called "AMG EV process".

Additional information is available via the following link https://www.pharmnet-bund.de/static/de/unternehmen/produktinformationstexte/index.html

The PDF files will be published without additional formatting or correction by the BfArM. Therefore, you should not send versions with tracked changes mode, containing comments or annotations, with headers or footers indicating the text as confidential or related to previous assessment steps or draft versions or similar information which would sound strange to the public. In case of doubts on how the design and layout should be please, consult the following document:

No, this is not required. The nationally translated product information texts and the text version as authorised after end of the procedure regardless of the language are not part of the eCTD or NeeS dossiers. The only purpose of the requested submission is to receive a proper text version ready for publication on the PharmNet.Bund website (www.PharmNet.Bund.de ) in accordance with Section 34 AMG.

Yes, the 7-digit number of the pharmaceutical entrepreneur (PNR) is identical to the number of the applicant in the medicinal product database.

No. The BfArM will check against entries in the respective database and will set the requirement on hold until the case has been finalised.

For the allocation of a PNR, please contact the e-mail account Partnerinformationen@bfarm.de stating "Application for a new PNR" in the subject line.

In order to create a PNR in the pharmaceutical companies database "Partnerinformationen", the following documents are required:

1. Excerpt from the Commercial Register, preferably with history
   Historical data are used to track name and address changes, so that the database can be checked for a PNR which has already been issued for the old name or address.

2. Official letterhead
   This serves to determine the following data:

   • exact spelling of the name
   • company address
   • possibly different postal address
   • telephone and fax number
   • e-mail address
   • Commercial Register data: HR no., competent court and place of jurisdiction
3. OMS-Data (Identifier from EMA´s SPOR - Organisations Management System)
   Please also provide the ORG-ID and Loc-ID from OMS. Should you not be aware of these IDs, please check OMS or request new IDs prior to applying (https://spor.ema.europa.eu/omswi/#/).
4. Power of attorney
   If you wish to apply for a PNR on behalf of a company you are not working for, you will also be required to submit a power of attorney.
5. We allocate separate PNRs for manufacturing sites, even if these are located at the company's head office. In addition to the documents listed above, supporting documents such as GMP certificates or manufacturing authorisations are required for creating a new PNR.

You can search for medicines free of charge at www.pharmnet-bund.de. The ENR for the medicinal product and the PNR for the pharmaceutical entrepreneur are also available here.
For new marketing authorizations, the ENR and PNR will be provided to you in writing by the BfArM upon request.