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1 AIPS User Manual (Preparation Documents)

This manual describes how to use the application for managing preparation documents on the SIMIS (Swiss Integrated Medicines Information System) platform:

• For organisations in the human medicine sector (HAM): professional information (PI), patient information (PIL).
• For organisations in the veterinary medicine sector (TAM): professional information (PI), package leaflet (PL).

The target audience consists of professional users who create, edit, publish, withdraw, or adopt documents from another organisation.

The manual is structured in a practice-oriented way. It focuses on typical use cases that describe how you use the application in various situations.

1.1 Basic principles of medicinal text structure

• For each authorisation number and document type, there is a language set consisting of one language document each in German, French, Italian, and optionally English – also referred to as a preparation document.
• The preparation document is always published or withdrawn together with all existing languages. Individual languages cannot be published or withdrawn separately.

1.2 Getting started (within the SIMIS application)

After successfully logging in to the SIMIS application, you access the management of preparation documents via:

• the Preparation Documents tile, or
• the side navigation AIPS > Preparation Documents

By default, the Preparation Document List Screen is displayed.

2 Overview of the most important screens

Preparation Document List Screen (S300)

• Overview of all current documents, including search and filter functions.
• This is the entry point for new documents and for managing existing documents.

Preparation Document Detail Screen (S310)

Main working interface with status display, master data, and documents in various languages.

Preparation Document Metadata New Screen (S320)

Input screen for creating a new preparation document.

Preparation Document Metadata Edit Screen (S330)

Screen for editing the master data of an existing preparation document.

Preparation Document Information Upload Wizard (S335)

Three-step wizard for uploading language documents (Word or PDF).

Preparation Document Publish Confirmation Screen (S312)

Dialog for setting a publication date.

Preparation Document Withdraw Confirmation Screen (S314)

Dialog for setting a withdrawal date.

Preparation Document History Screen (S340)

Display of all published versions of a preparation document.

3 Typical use cases

3.1 Creating a new preparation document

As a user, I want to create a new preparation document in order to store the master data in the system.

Procedure:

1. Open the Preparation Document List Screen.
2. Select the New Preparation Document button.
3. Enter the master data in the Preparation Document Metadata New Screen. This includes:
   • Working title
   • Main text language
   • Authorisation number(s)
   • Dosage strengths (optional)
   • Document type (depending on the medical field)
   • other fields such as application ID, remarks, etc.
4. Save the entries.
5. You are automatically taken to the Preparation Document Detail Screen.

The preparation document is now in the status Work in progress.

3.2 Uploading individual languages

As a user, I want to upload individual language documents so that I can publish them.

Procedure:

1. Open the Preparation Document Detail Screen.
2. In the documents area, select the Upload action menu.
3. The Preparation Document Information Upload Wizard opens. Go through the three steps:
   1. Select file: Upload a document:
      • For simplified publication in accordance with Art. 26 para. 4 TPO: you must select a PDF document.
      • Otherwise, you must select a WORD document.
   2. Status: Review the processing result (success or error).
      • Errors must be corrected directly in the WORD document. Then upload it again (step 1).
   3. Completion: Add or correct required information such as brand name and information revision date.
4. Save the entries. The language document is stored in the system and displayed in the document list.
5. Repeat the process for additional language versions.

3.3 Publishing a preparation document

As a user, I want to publish a preparation document – i.e. with all languages currently present in the language set – so that it becomes officially valid.

Procedure:

1. Open the Preparation Document Detail Screen.
2. Ensure that the master data is complete and that at least the document in the main text language has been uploaded.
3. Select the Publish action.
4. In the Preparation Document Publish Confirmation Screen, set the publication date (at the earliest the following day).
5. After confirmation, the status changes to Scheduled to publish.
6. The system automatically sets the document to the status Published as soon as the selected date is reached.

3.4 Withdrawing a preparation document

As a user, I want to withdraw a preparation document so that it is no longer published.

Procedure:

1. Open the Preparation Document Detail Screen.
2. Select the Withdraw action.
3. In the Preparation Document Withdraw Confirmation Screen, enter a withdrawal date (at the earliest the following day).
4. After confirmation, the status changes to Scheduled to withdraw.
5. The system automatically sets the document to the status Withdrawn as soon as the date is reached.

3.5 Modifying a preparation document

As a user, I want to make changes to a published document, for example uploading a new language or updating an existing language.

Procedure:

1. Open the Preparation Document Detail Screen.
2. Select the Modify action.
3. The system creates a new version in the status Work in progress.
   • Master data is carried over.
   • The "Adopted by Organisation" indication is no longer displayed.
4. Edit the master data if necessary in the Preparation Document Metadata Edit Screen.
5. Upload new or changed language documents using the Preparation Document Information Upload Wizard (see chapter "Uploading individual languages").

3.6 Transferring an authorisation number Organisation A → B (Adoption)

As a user, I want to adopt an authorisation number from another organisation.

Procedure:

1. Open the Preparation Document List Screen.
2. Select the New Preparation Document button.
3. Select the source organisation in the Adopted by Organisation field.
4. Enter authorisation numbers and dosage strengths identical to the original.
5. Upload your own language documents (these are not carried over).
6. Publish the document. Publishing version 1 automatically withdraws the source organisation's original document.
7. You can then modify and publish the document as usual.

3.7 Viewing preparation document history

As a user, I want to see the history of a preparation document in order to trace its previously published versions.

Procedure:

1. Open the Preparation Document List Screen.
2. Select the History entry in the action menu.
3. In the Preparation Document History Screen, you can see all previously published versions.
4. If needed, you can download the language versions (PDF only) of a version collectively as a ZIP file.

3.8 Using search and filter

As a user, I want to quickly find a specific preparation document.

Procedure:

1. Open the Preparation Document List Screen.
2. Use the free-text search to search by working title, authorisation number, or "last edited by".
3. Use the filter to narrow down specifically by status, editing date, publication date, or withdrawal date.

4 Direct links to medicinal information

As a user, I want to be able to link directly from my website to the medicinal information of my products.

4.1 URL to www.swissmedicinfo.ch – Patient information

For use, e.g. on corporate websites or in email correspondence, the following deep links to the patient information/package leaflet can be used:

• www.swissmedicinfo.ch/01/"GTIN" or
• www.swissmedicinfo.ch/p/"8-digit authorisation number"

4.2 URL to www.swissmedicinfo-pro.ch – Professional information

Currently, the new, language-neutral deep links cannot yet be used for the website www.swissmedicinfo-pro.ch. The renewal of the swissmedicinfo-pro.ch website will take place during the second half of 2026.

The existing deep links to the professional and patient information remain valid indefinitely and are redirected, depending on whether it is professional or patient information, to swissmedicinfo.ch or swissmedicinfo-pro.ch.

• https://swissmedicinfo.ch/showText.aspx?textType=[FI]&lang=[DE]&authNr=[NNNNN]&supportMultipleResults=1

5 Tips and best practice

Regarding the application

• In the Preparation Document List Screen, withdrawn documents are not displayed by default. To display them, use the filter settings.
• Use consistent working titles to make it easier to find documents again.
• Where possible, upload the document in the main text language first. Only then should you add additional language versions.
• Make sure that authorisation numbers match between the master data and the uploaded documents.
• If an authorisation number has only three or four digits, add leading zeros so that it is entered correctly in the system (e.g. "01234" instead of "1234").
• Use the Preparation Document History Screen to ensure regulatory traceability at all times.
• Before every publication, carefully check the information in the Preparation Document Detail Screen to avoid errors in the release process.
• A document in the status Work in progress can be deleted at any time without affecting published or other versions.

What to pay attention to when completing the Swissmedic WORD templates

• The predefined titles must never be changed or deleted.
• The authorisation number must always be entered with five digits. If the authorisation number has fewer than five digits, add leading zeros.
• The form controls of the Swissmedic WORD template no longer need to be deleted.
• The following image formats are converted for publication in HTML and PDF: *.bmp, *.jpg, *.png
• For correct display of tables, automatic hyphenation and the use of conditional hyphens must be configured.

Possible errors when uploading WORD documents (at step 2)

Type='MissingValue' Section='28' Title='Authorisation number(s) parsing'

Type='SectionIsMissing' Section='28' Title='8. NUMERO/I DI OMOLOGAZIONE'