Adverse Reaction Reporting

By establishing and operating the Adverse Reaction Reporting service, Olikla (CZ Pharma) complies with its pharmacovigilance legal obligation, as a marketing authorisation holder, to collect information about the risks of medicinal products. This obligation is stipulated in Act No. 70/2013 Coll., Amending the Drugs Act, Section 91(1)(a).

Our company also, beyond the statutory requirements, provides this service for medicinal products where we are the sole distributor in the country, not solely a marketing authorisation holder.

Pharmacovigilance is concerned with monitoring the safety of medicinal products in order to ensure their safe, proper and effective use. Timely and understandable reporting of adverse reactions can contribute to the improved safety of drugs used. To report an adverse reaction, use one of the following options:

1. Adverse reaction reporting form

Reporting through our online Adverse Reaction Reporting form.

Personal data
Description of adverse reaction
Medicinal product suspected of adverse reaction
Contact details of the administering doctor
*Required fields

By filling in and submitting the Adverse Reaction Reporting form, the submitter agrees to the processing of the personal data provided by Olikla (CZ Pharma), in particular with the report validation and storage and transmission of data in accordance with statutory requirements relating to the monitoring of the safety of medicinal products. Address and identification data are processed in the seat of the controller in accordance with the Czech Act on the Protection of Personal Data, as amended.

2. Czech State Institute for Drug Control

Reporting directly, through the national system, to the Czech State Institute for Drug Control, which operates the pharmacovigilance system for the Czech Republic within the EU. Report ideally by filling in the online form, sending a detailed email to [javascript protected email], or by mail to Státní ústav pro kontrolu léčiv, oddělení farmakovigilance, Šrobárova 48, 100 41 Praha 10, Czech Republic.

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