Product information texts

Product information texts

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".

Access and user authorisation

There is a role-based, central authentication and registration for the access to applications. The roles differentiate between the administrator in the higher federal authorities and the main user(representative) in a company or an authority. Other users are created and administrated by the representative.

More information about the request access authorization and user administration can be found in the user manuals below.

Supporting information

• Short manual for Product information texts (PDF, 482 kB)
• Manual Request access authorization (PDF, 93 kB)
• Manual My Data (PDF, 304 kB)
• Manual User administration (Higher Federal Authority) (PDF, 266 kB)
• Manual User self-administration (Companies / Federal Authority) (PDF, 245 kB)
• General terms and conditions for the user authorisation (PDF, 44 kB)
• Terms and conditions for the product information texts application (PDF, 98 kB)