Patients should always seek the advice of a doctor or pharmacist in case of adverse events.
If you wish to report an adverse event to ELC Group s.r.o., please find the contact information below:
To contact us about any other issue please call:
Pacienti by meli vždy požádat o radu svého lékare nebo lékárníka v prípade výskytu nežádoucích príhod.
Pokud chcete nahlásit nežádoucí príhodu spolecnosti ELC Group s r.o., prosím využijte kontaktních údaju níže:
Pro záležitosti, které se netýkaji farmakovigilance, kontaktujte prosím recepci:
+420 22 491 0000 nebo naše další pobočky.
Readability of patient information leaflets
readability tests and bridges performed
PIL and package mock-ups created
success rate for our readability tests
If any query arises, we would defend the report in front of the concerned Health Agency free of charge.
We aim to minimise the number of tests you need to perform and expedite your approval process.
We will look at your portfolio, assess the leaflets and advise on the best approach.
A Bridging Report is created to justify why a leaflet (the “daughter PIL”), does not need to be tested by linking it to a successfully user tested leaflet (the “parent PIL”). It applies to leaflets that are very similar in content, style and layout.
A Bridging Report is more effective when a strategy is established.
In case the “daughter PIL” is based on 2 “parent PILs”, a Double Bridging Report can be performed. This happens, for example, if the “daughter PIL” has similar text to “parent PIL A” and a similar format to “parent PIL B”.
A Bridging Statement is created to justify why a leaflet (the “daughter PIL”) does not need to be tested by linking it to a successfully user-tested leaflet (the “parent PIL”). It applies to leaflets that are almost identical in content, style and layout.
A Focus Test is a combination of testing and bridging. It can be performed when there is a similarity between the leaflets but with some key differences in the safety information that cannot be justified by a Bridging Report alone. The differences are tested, following the standard process of a Readability Test, and the remaining text is bridged by a Bridging Report.