ElViS – Electronic Vigilance System
Electronic Vigilance Reporting Portal
Since the start of October 2014, healthcare professionals and pharmaceutical companies have been able to report suspected adverse drug reactions directly via the Internet.
This means that small and medium-sized pharmaceutical companies that do not have their own access to the Swissmedic pharmacovigilance database via the Gateway can now submit their reports to Swissmedic electronically. Similarly, healthcare professionals who have been using report forms to notify the regional pharmacovigilance centres of suspected ADR can now prepare and send their reports online.
ElViS can also be used to send case-related documents such as laboratory or hospital discharge reports. Once their report has been sent, users can save it and the acknowledgement of receipt on their computer’s hard drive for their own records. Data protection and security satisfy the most stringent requirements.
This modern, user-friendly reporting portal makes it easier for healthcare professionals and the industry to fulfil their statutory reporting obligations. Swissmedic hopes that this solution will result in faster submission of better-quality reports, thereby improving drug and patient safety in Switzerland.
Registration for MAHs
1. The MAH registers for ElViS on the Swissmedic website:
2. The Informatics Service Center of Swissmedic (ISCS) creates a contract
3. The MAH signs the contract and delegates a Partner-Administrator
4. ISCS creates the Partner-Administrator Account
Registration for HCPs
The registration for HCPs is described step by step in the document below:
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FAQ - ElViS
Why do I have to register?
Where do I register?
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.
What's the difference between a "direct insert" and a "file upload"?
Registration for MAHs
MAHs should register for ElViS on the Swissmedic website here. A ticket will automatically be created at Swissmedic and your request to use ElViS will be processed. Once we have reviewed the information you have provided, you will receive an ElViS user agreement.
Registration for HCPs
Go to the ElViS page of the Swissmedic website. Click HCP Registration . You will find detailed instructions on how to register here
I've forgotten my password. What should I do?
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". 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.
What's the quickest way to get to the ElViS login page?
Do I have to enter data in a particular order?
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.
What should I do if I don't know the patient's exact date of birth or precisely when an ADR began, for example?
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.
What's the difference between "Designation of the ADR" and "Description of the ADR"?
Enter the full date or birth or leave the field empty.
How do I save the data I have entered?
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.
What do I do if I want to resume work on a report I've saved?
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.
What does "Add attachments" mean?
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.
Will I receive confirmation that my report has been sent?
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.
I've clicked the link in the e-mail, but get a "Documents not found" error message.
If your report has been successfully received by the RPVC and imported into Swissmedic's drug safety database, you will receive an e-mail. This e-mail will contain a link that you can click to download further documents, including confirmation of receipt.
There's a "Valid until" date with the reports I have sent and accompanying documents. What does that mean?
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.
Submitting follow-up reports
Receiving messages and answering queries
How do I know if there are any messages or queries for me?
What exactly is the difference between a message and a query?
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.
Can I also reply to queries by phone?
A message from the Regional 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.
Certainly. The Regional Pharmacovigilance 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.