Enhanced Pharmacovigilance FAQ

Enhanced pharmacovigilance (enhanced PV) is the targeted, structured collection of data on specific safety issues associated with a medicinal product following market authorisation. It comes into effect when the data situation indicates that further information needs to be collected.

Usually this involves obtaining follow-up information on specific spontaneous cases from the reporting source using customised questionnaires containing specific relevant questions. For example, all case reports of encephalopathy associated with a particular medicinal product could be followed up as a way of generating additional data on their outcome.

Last updated on:17.02.2016

Enhanced PV measures can be ordered as part of a Risk Management Plan (RMP) or initiated separately by Swissmedic independently of an RMP if specific information is required to minimize the risk associated with a safety signal. Marketing authorisation holders can also initiate enhanced PV measures themselves.

Last updated on: 17.02.2016

Early coordination and planning with Swissmedic are required if the National Pharmacovigilance Centre and the regional centres are to be involved in data collection activities. Swissmedic and the marketing authorisation holder define the scope and organisational procedure for collecting the data. The envisaged procedure, including the expected time frame, is then agreed in writing with Swissmedic.

Last updated on: 01.01.2021

The following documents should be submitted to Swissmedic:

• Description of the planned measures, e.g. RMP or another relevant document.
• Specific description of how the measures will be implemented in Switzerland.
• Materials for recording the data (e.g. questionnaires) in all the languages used.

Last updated on: 17.02.2016

The collection of additional information from the primary reporting source by the National Pharmacovigilance Centre and the regional centres will involve extra costs resulting from additional contacts with the primary reporter and the extra work involved in entering and processing the case. Swissmedic will charge the marketing authorisation holder for the time involved in this extra work.

Last updated on: 01.01.2021

Questions relating to enhanced PV should be sent to the Risk Management unit (Safety of Medicines Department) at riskmanagement@swissmedic.ch

Last updated on: 17.02.2016