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SPECIFIC TERMS OF USE FOR

- AIPS (Medicines Information Publication System FI/PI)
- SAI (Structured Drug Information)

The Refdata Foundation (hereinafter Refdata), with its registered office in Zug, Switzerland, makes the officially approved medicinal product information of medicinal products authorised in Switzerland (hereinafter INFORMATION) available in structured form on the SAI platform and as health professionals and patient information on the AIPS platform in accordance with the following provisions:

1. Completeness, correctness and up-to-dateness of the INFORMATION:

1.1. AIPS

As part of the authorisation procedure, Swissmedic checks the INFORMATION provided to it by the authorisation holders to ensure that it is correct and up to date. The authorisation holder is responsible for the publication of the INFORMATION approved by Swissmedic and for the correct translation of the texts into the AIPS. The marketing authorisation holders are obliged to adapt the INFORMATION to the current state of knowledge if necessary. These adaptations are checked and approved by Swissmedic and, if necessary, also requested.

However, Refdata cannot make promises or give any warranty whatsoever that the INFORMATION is complete, accurate or current at all times. The INFORMATION may also contain technical inaccuracies or typographical errors. The INFORMATION may be changed, supplemented, or deleted at any time and without prior notice. Decisions on the authorisation of a medicinal product, the revocation, withdrawal, cancellation or suspension of an authorisation continue to be officially published in Swissmedic's official publication organ. The Swissmedic Journal is available at https://www.swissmedic.ch/swissmedic/en/home/ueber-uns/publikationen/swissmedic-journal.html."

1.2. SAI

Refdata publishes the INFORMATION provided publicly and electronically by Swissmedic in structured form in the SAI. However, Refdata cannot make promises or give any warranty whatsoever that the INFORMATION is complete, accurate or current at all times. The INFORMATION may also contain technical inaccuracies or typographical errors. The INFORMATION may be changed, supplemented, or deleted at any time and without prior notice.

Decisions on the authorisation of a medicinal product, the revocation, withdrawal, cancellation or suspension of an authorisation continue to be officially published in Swissmedic's official publication organ. The Swissmedic Journal is available at https://www.swissmedic.ch/swissmedic/en/home/ueber-uns/publikationen/swissmedic-journal.html."

The additional information in the SAI on [GTIN] and [trade status] of a medicinal product are not mandatory fields. The marketing authorisation holder is responsible for maintaining and updating this voluntary information. If no information has been provided by the marketing authorisation holder, the [GTIN] field is empty and the [Trade Status] field reads "No information made available".

 

2. Not a substitution for counselling by medical professionals

The INFORMATION contains the officially approved information on the benefits and risks of the authorised medicinal products. The doctor is responsible for prescribing prescription-only medicines. It is also recommended that you consult a doctor, pharmacist or other healthcare professional for non-prescription medicines.

The INFORMATION should not be used by private individuals as a decision-making aid for health-related or other decisions. Under no circumstances does the INFORMATION provided replace a diagnosis or advice from a doctor, pharmacist or healthcare professional. Individuals should always seek advice on health matters from a qualified medical professional.

 

3. Access and availability of INFORMATION

Access to the INFORMATION is at the user's own risk. In particular, Refdata does not guarantee access to the INFORMATION, the availability of the INFORMATION at all times or the error-free functioning of the applications. Refdata cannot guarantee that the INFORMATION is free of viruses or other harmful components. Refdata disclaims all liability for any direct or indirect damage resulting to the user or third parties.

Refdata expressly reserves the right to block or restrict access to the INFORMATION at any time and without prior notice.

 

4. Disclaimer

Refdata accepts no responsibility whatsoever arising from any use of the INFORMATION and measures based thereon. Refdata disclaims, to the fullest extent permitted by law, all liability for any direct or indirect damage of any kind whatsoever to the user or to third parties resulting from the use of the INFORMATION.

 

5. Rights of Refdata, rights of users

Refdata or the authorisation holders are entitled to all ownership and property rights to the INFORMATION.

Querying, displaying and printing (download PDF print) of the INFORMATION are permitted.

The export of the INFORMATION (XML download) for use of the data outside this application, the further use and editing of the INFORMATION as well as the use for public or commercial purposes are permitted.

 

6. Subject to change

Refdata expressly reserves the right to change these terms of use at any time and without prior notice as part of the respective updates. The user must regularly check the applicable terms of use before use.

 

7. Jurisdiction and applicable law

For all legal relationships arising from the user's access to the INFORMATION, there is an exclusive place of jurisdiction at the registered office of Refdata. The legal relationships are exclusively subject to Swiss substantive law, excluding the UN Convention on Contracts for the International Sale of Goods of 11 April 1980.

The official text is in any case the German version. Deviations or differences arising from the translation are not binding and have no legal effect with regard to compliance with or infringement of regulations and laws.

 

Last changes: 1st March 2021

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