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Pharmacovigilance · Safety

Publicly available professional information service (VPOIS)

The obligation to establish a publicly available professional information service (VPOIS) arises from Act No. 378/2007 Coll., on Pharmaceuticals.

Do you suspect an adverse reaction?

Contact our safety department directly.

safety@pharma-service.cz →

Information about medicinal products

Information about our products can be found on the State Institute for Drug Control website in the drug database here →

Product information (Summary of Product Characteristics or Patient Information Leaflet) is available by entering the product name, clicking Search, and then selecting the relevant product.

Reporting side effects and incidents

If you suspect a side effect of a medicinal product or an adverse incident involving a medical device, please inform your doctor or pharmacist. The same applies to any side effects not listed in the package leaflet of the medicinal product.

An adverse incident involving a medical device is defined as

aAny malfunction or deterioration in the characteristics or performance of a medical device, or any inaccuracy in the labeling or instructions for use, which has led or could have led to the death of a user or other person, or to a serious deterioration in their state of health.
bA technical or medical reason related to the characteristics or performance of a medical device that leads the manufacturer to systematically recall the same type of medical device from the market for the reasons stated in point a).

Any suspected serious or unexpected side effect, any adverse incident involving a medical device that meets the basic criteria, and any other facts significant to the health of treated individuals must be reported to the State Institute for Drug Control.

Basic criteria

An incident has occurred.
There is a suspicion that the medical device contributed to the cause of the incident.
The event led to, or could have led to, the death of a patient, user, or other person, or to a serious deterioration in their state of health.

Where to report

You can also report side effects directly through the national reporting system. Details on how to report can be found at www.sukl.cz/nahlasit-nezadouci-ucinek

Postal address

State Institute for Drug Control, Pharmacovigilance Department, Šrobárova 48, Prague 10, 100 41
e-mail: farmakovigilance@sukl.cz

You can also report suspected side effects and other information regarding the safety of medicinal products, or suspected adverse incidents involving Novatin medical devices, by phone or email:

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