Undesirable effect/adverse event reporting

Reporting drug side effects. Reporting an adverse event of a medical device

If you want to report an adverse drug reaction or any other complaint about EGIS Praha's medicinal products, please contact us as soon as possible, call us at +420 227 129 112 or write to e-mail: farmakovigilance@egispraha.cz

Please specify:
what medication is the unintended or adverse response related to,
when you or your patient experienced an adverse reaction,
reaction to a drug you consider an adverse reaction,
if you are a patient, please give the contact to your doctor who treated you when the side effect occurred,
Your contact details (name and surname, telephone number, e-mail).

SUKL Reporting

Another option for patients and healthcare professionals is to report adverse reactions using the form on the website of the State Institute for Drug Control (SUKL) http://www.sukl.cz/nahlasit-nadadouci-ucinek

A suspected adverse reaction should also be reported as it is very difficult to decide whether there is a relationship between an adverse reaction and the administration of the medicinal product.

Your personal data will be processed in accordance with the law.

 
Reporting an adverse event of a medical device

What is an adverse event?

According to Act No. 268/2014 Coll., On medical devices, an adverse event means:
(a) any failure or deterioration of the properties or efficacy of the medical device or inaccuracy in the labeling of the medical device or in the instructions for use which have led or could lead to the death of the user or other natural person;
(b) a technical or medical reason in relation to the characteristics or efficacy of the medical device and leading the manufacturer for the reasons referred to in point (a) to systematically withdraw a medical device of the same type from the market.

Any event that meets all three of the basic criteria below is considered an adverse event and must be reported to SUKL.

These criteria are:
there was an incident,
there is a suspicion that the medical device was involved in the cause of the incident,
the event has led or could lead to the death of the patient, user or other person, or a serious deterioration in their health.

At the same time, however, it is better to report the event in case of doubt whether it is undesirable or not.

If you want to report an adverse event of a medical device to EGIS, call us at +420 227 129 112 or write to e-mail: farmakovigilance@egispraha.cz

Please specify:
medical device information (trade name, batch number),
Adverse event information (exact description of adverse event, number of patients affected)
patient information (initials, sex year of birth),
Your contact details (name and surname, telephone number, e-mail).

SUKL Reporting

Another option for patients and healthcare professionals is to report adverse events using the form on the website of the State Institute for Drug Control (SUKL) by telephone, fax, e-mail (e-mail: urgent@sukl.cz), by mail to the State Institute for Control Drugs (SUKL), or a completed Form.

Your personal data will be processed in accordance with the law.