eGovernment

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:


 


eGov Service eSubmissions

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.


eGov Service CPP (Certificate of a Pharmaceutical Product)

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.


eGov Service eMessage

eMessage is an eGov service that enables electronic data on topics approved by Swissmedic to be submitted to Swissmedic. eMessage users are private individuals or companies. A user account must be opened and available for the use of this eGov service. Data are sent by the users and correspondence is received by Swissmedic via this user account.


Swissmedic Portal – access and user administration

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 – Electronic Vigilance System

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.


B2B gateway for pharmacovigilance reports

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.


MESA – National trade register for controlled substances


NDS-WEB (National Drug Control System)

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.


Last modification 01.05.2018

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