Reporting/submitting suspected adverse drug reactions by pharmaceutical companies

Electronic reporting offers a large number of advantages. Your data are recorded in a structured fashion and checked to ensure they are complete and plausible before they are submitted. Furthermore, you can attach important documents such as laboratory reports, hospital letters, etc. to your report. Your report is imported directly into Swissmedic's drug safety database, where it can be processed immediately by the National Pharmacovigilance Centre. This means that risks are identified earlier and more accurately. Further advantages include data security and the fact that all documents are electronically archived.

ElViS is primarily a reporting platform, not a database. That's why submitted reports are only stored in ElViS for a limited period of time. However, you can resume work on any unfinalised report that you store in ElViS whenever you want.

No more than 6 weeks. It is the responsibility of each user to archive their reports and accompanying documents on their own computer.

For the ELVIS application we recommend the following browsers: Microsoft Edge und Mozilla Firefox

Please contact the ElViS hotline by e-mailing it@swissmedic.ch or by calling +41 58 462 06 00. The hotline is open from 7.30 a.m. to 5.30 p.m., Monday to Friday.

Once-only registration is required before you can use ElViS. This is to ensure that the data you submit are transmitted securely and to unequivocally link senders to reports. Registration doesn't take long and all the information you provide will be treated in strict confidence.

You need to register before using ElViS, but this only takes a few minutes. It is important for you to make a one-off decision on whether to log in with a HIN identity or use the CH-LOGIN. The use of two identities and switching between these accesses is not recommended, since reports can be viewed and processed only via the respective login.

• Healthcare professionals with a HIN identity (login)

• Healthcare professionals without a HIN identity (login)

If you want to type your report into an online entry mask, choose "direct insert". This is the standard option for most users. If you have an electronic system capable of generating E2B files and you want to upload these files to ElViS, choose "file upload". ElViS can only be used with the E2B-R2 format. This option will normally only be available in specialised centres. You will have to contact the ElViS hotline before you can start a file upload. The same applies if you have chosen a file but then want to change it.

You can reset your password yourself. Click the "Forgotten password" link on the login screen.

Go to the Swissmedic website and click "Log in ElViS" at the top right of the screen. Alternatively, you can add the login page to your favourites/bookmarks.

No. ElViS will suggest a predefined order, but you can choose which screen you want to enter data on simply by clicking in the menu bar on the left-hand edge of the screen.

Enter the full date or birth or leave the field empty.

As the designation, enter a symptom or diagnosis, e.g. headache or rash. You can then describe the diagnoses, symptoms, findings, treatment and course in detail in the description section.

You can save any data you have entered without submitting it if you click the drop-down menu (i.e. the small white triangle) to the right of the "Next" button and click "Save". Please note that you can only save one report in ElViS and will therefore have to save that report on your own computer before you can start to enter another one.

If you have saved your report in ElViS, click "Edit" under "Continue report saved in ElViS". If you have saved your report on your own computer, click "Continue a locally saved report", choose the appropriate file and upload it to ElViS.

If you have test results (e.g. lab reports) or other documents (e.g. hospital letters) that are relevant to a report, you can send them with your report. You can add one or more attachments in any file format.

If your report has been successfully received by the National Pharmacovigilance Centre and imported into Swissmedic's drug safety database, you will initially receive an e-mail. This e-mail will contain a link that you can click to download further documents, including a confirmation of receipt.

You've probably already downloaded your report and associated documents. These are automatically deleted 24 hours after they have been downloaded and the link will cease to work.

Reports and accompanying documents are stored in ElViS for six weeks. It is the responsibility of each user to archive their reports and accompanying documents on their own computer. Reports and documents are automatically deleted 24 hours after they have been downloaded. If you have not yet downloaded the relevant files, you will receive an e-mail about one week before the six-week deadline expires.

Yes, you can attach one or more files in any format, just as you can for an initial report.

Yes. If your report is still stored in ElViS, click the report’s ElViS case number in “Sent reports”, then click “Write follow-up”. The report number field will be automatically completed so that your follow-up report can be unequivocally linked to your initial report. If your initial report is no longer stored in ElViS, simply click “Write follow-up”, then upload the E2B file for the initial report. The report number field will be automatically completed. Alternatively, you can also complete the report number field manually.

You cannot submit a follow-up report without the original report number. Please contact the ElViS hotline.

You will receive an e-mail when your follow-up report has been successfully received by the National Pharmacovigilance Centre. This e-mail will contain a link that you can click to download further documents, including confirmation of receipt.

There is no limit on the number of follow-up reports you can submit for a particular initial report.

Reports from healthcare professionals are evaluated in the Swissmedic National Pharmacovigilance Centre and, in some cases, in the regional centres. The primary reporter receives a confirmation of receipt of the report and a written evaluation if the report was forwarded to a regional centre for processing.
All evaluated reports are completely anonymised and entered in the national database. If reports are incomplete, it might be necessary to get back to the primary reporter via the regional centre. The pharmaceutical industry forwards any reports it receives directly to Swissmedic.
Swissmedic, in turn, forwards all reports to the international centre for drug safety at the World Health Organization (WHO) as it is an active member of the Programme for International Drug Monitoring.

The Swissmedic pharmacovigilance team carefully screens all incoming reports for new risks. If a new risk is identified, the need for action is evaluated and appropriate measures are taken in collaboration with the Swissmedic department responsible for the drug concerned.

You will receive e-mail notification if there are messages or queries concerning a report that you have submitted. You will see them under “Received messages” or “Queries” when you log into ElViS.

A message from the National Pharmacovigilance Centre contains information on a report you have submitted. There is no need for any action on your part. If you receive a query, however, you will be asked to respond by downloading the relevant document to your own computer, processing it there and then uploading it once again to ElViS.

Yes, this is possible. The National Pharmacovigilance Centre or a regional centre may well contact you by phone. However, if you prefer to use e-mail, please remember that e-mail is not a secure way of transmitting sensitive data.