Vigilance

You are here: Home \ Vigilance

What is Vigilance?

 

The term ‘Vigilance’ has been used by the UK Department of Health/MHRA to describe the system whereby safety issues of marketed products are monitored, assessed and reported. It is an important part of TPD compliance.

 

The Legal Basis

 

Article 20 (9) of the TPD requires Member States to ensure that manufacturers, importers and distributors set up a system for collecting information about side effects of vaping. Businesses are also required to inform the authorities of any risks to public health should they emerge on a given product.

 

How a Vigilance system works

 

Vigilance Person

Producers in the UK should appoint a competent person with the role of Vigilance.  Their main responsibility is to immediately notify the authorities should a change occur in the safety profile of a product. Other tasks include maintaining and managing the Vigilance system and ensure that all information about suspected adverse events are collected and organised.

 

Product Overview

For each product an overview of the potential and emerging health concerns should be identified.  In the case of e-liquids, the overview may include reports of the toxicological studies on the flavour compounds, which should be updated when new studies are published.

 

Documentation

An important element of Vigilance is documentation; all aspects and activities of the vigilance system should be described. Documentation may be subject to inspection by the MHRA or Trading Standards.

 

How can we help?

 

In the absence of Vigilance guidance for e-cigarette products the pharmaceutical equivalent can be a model. We help producers establish and maintain a Vigilance system based on this model.

Grow your business in Europe

GET STARTED

What We Do

We are a European regulatory consultancy. We advise e-cigarette companies on the emerging regulations and help pharmaceutical companies obtain and maintain medical product licences.