What is eGovernment?
eGovernment involves the use of information and communications technologies (ICT) to enable the public and businesses to conduct important transactions with government agencies electronically.
Why is Swissmedic adopting eGovernment?
Process-centred eGovernment applications (eGov services) will benefit external stakeholders by simplifying and speeding up interaction and administrative processes. Swissmedic wants to maximise the number of eGov service users and will endeavour to make useful additions to its range of services over the coming years.
The following eGov services are currently available:
To improve electronic data exchange, Swissmedic has developed a new eSubmissions platform, which enables authorisation holders to submit applications electronically to Swissmedic for processing. This new platform commenced pilot operation on 10 October 2016. Once the test phase has been completed – probably as of the second quarter of 2017 – the first step will enable all authorisation holders to use the platform to submit applications for authorisation of medicinal products in eDok and eCTD format.
The eGov CPP service is used for the secure electronic ordering of product certificates (CPP: Certificate of a Pharmaceutical Product) from Swissmedic. The order and the required associated documents are transmitted in encrypted form. No locally installed software is needed to transmit the order.
You can access each of Swissmedic's eGov services via the Swissmedic Portal. The Portal provides secure electronic communication between you and Swissmedic.
Depending on the eGov service you want to use, you can either register yourself as a user or have two user administrators created for your company. As a user administrator you assign access rights to users within your company.
This enables you to keep an overview, manage your own user accounts and ensure they are up to date yourself.
The Swissmedic Portal gives you access to the Application Tracking/Document Exchange and ElViS eGov services.
The Application Tracking/Document Exchange eGov service enables you to track the current processing status of your applications for authorisation by means of defined milestones.
The document exchange function enables you to exchange medicinal product information documents with us quickly and securely at any time during application processing.
ElViS provides a simple, secure and rapid way to exchange adverse drug reaction (ADR) reports and documents with the Regional Pharmacovigilance Centers (RPVC).
ElViS is designed for health care professionals (HCP) and marketing authorisation holders who do not use the existing B2B gateway to send ADR reports to Swissmedic. ElViS offers the choice of entering ADR online or uploading an E2B-compatible file.
The B2B gateway is a system interface that can be used to electronically send and receive suspected adverse drug reaction reports (individual case safety reports, ICSR) in E2B format. This service is designed to appeal particularly to marketing authorisation holders who send a large number of reports.
Users must also have an IT infrastructure that is suitable for linking up to the Swissmedic B2B gateway.
Under Article 60 of the narcotics control ordinance (BetmKV, SR 812.121.1) individuals and companies who hold appropriate authorisation from a federal authority must notify the agency of all domestic deliveries of controlled substances in schedules a, b or d. Reports can also be entered electronically using the MESA system. MESA is a web application that enables the individuals and companies in question to enter deliveries and quantities of preparations and active substances in the database either by entering the substance or preparation in the reporting mask or by uploading a report file.
Swissmedic then makes the data available to the responsible cantonal authorities in accordance with Art. 61 para. 3 BetmKV.
(National trade register for controlled substances)
Any individual or company that wants to import or export controlled substances needs an import or export licence from Swissmedic. Applications can be submitted to Swissmedic electronically using NDS-WEB.
After importing or exporting the substances, the licence holder is required to notify Swissmedic of the fact within 10 working days.
The substances are not deemed to have been exported or imported until this notification is received. Notifications form part of the licence and are also submitted via NDS-WEB.
(National Drug Control System)