Reporting/submitting suspected adverse drug reactions by pharmaceutical companies
Marketing Authorisation Holders (MAH) basically have two options for submitting suspected adverse drug reactions to Swissmedic:
- Electronic reports via the ElViS portal (Electronic Vigilance System)
Submitting reports via a web-based online tool
- Gateway for the electronic exchange of individual case safety reports
The reports are transferred directly to Swissmedic's database.
Registration processes are required for both options. Please note that, as of 1 July 2021, Swissmedic will only accept electronic reports either via ElViS or a Gateway connection.
Electronic reports via the ElViS portal
Submission via ElViS is intended for use by small to medium-sized pharmaceutical companies without their own access (via Gateway) to Swissmedic's pharmacovigilance database.
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
Why should I use ElViS to report adverse reactions?
Why can I only store one unfinalised report in ElViS?
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.
How long will reports that I submit be stored in ElViS?
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.
Are my data really secure?
No more than 6 weeks. It is the responsibility of each user to archive their reports and accompanying documents on their own computer.
ElViS satisfies the most stringent data protection and security requirements.
Whom do I contact if I have questions or problems?
For the ELVIS application we recommend the following browsers: Microsoft Edge und Mozilla Firefox
Please contact the ElViS hotline by e-mailing firstname.lastname@example.org 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.
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.
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 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.
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 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.
More companies connected to the Gateway for the electronic exchange of individual case safety reports
In December 2012 Swissmedic's Pharmacovigilance Gateway for the exchange of individual case safety reports on adverse drug reactions went live.
Like the European Medicines Agency (EMA) and other therapeutic products authorities, doing so has enabled Swissmedic to send and receive reports on suspected adverse drug reactions (Individual Case Safety Reports, ICSR) electronically and to make them available in a database. ICSR from clinical trials notified to Swissmedic cannot be transmitted via this Gateway.
The Gateway solution is primarily designed to enhance quality and efficiency. It dispenses with the time-consuming and error-prone process of entering data manually, freeing up everyone involved to focus on processing the contents of reports. Moreover, the Gateway's "Ack log" function (confirmation of items sent and received) makes it possible to seamlessly track reports.
Creating the corresponding support infrastructure in 2013, and changing over from WHO to MedDRA coding in spring 2014 have created the conditions for bringing other pharmaceutical companies onto the Gateway and for increasing the efficiency of report exchanges. New companies are currently in the process of being connected to the Gateway. Swissmedic’s aim is to exchange ICSR primarily via the electronic EGov portal. Companies with low report volumes can now submit them electronically via ElViS.
Companies interested in the Gateway solution must fulfil the following requirements:
- The company undertakes to pay the external activation costs of CHF 10,000. There are no plans for an annual subscription;
- The company undertakes to make the resources needed to integrate the Gateway solution available within about three months. This includes designating a coordinator;
- The company is able to exchange ICSR electronically using the AS2 or AS1 protocols.
Companies that are interested in using the Gateway solution and that fulfil the above requirements should send a letter of intent to email@example.com. After examining the letter, Swissmedic will contact the company to its involvement in detail.
Last modification 27.01.2021