Report a side effect
Processing of personal data
Who processes the data
The owner (controller) of the personal data is ТОВ «Харківське фармацевтичне підприємство «Здоров’я народу»» (Kharkiv Pharmaceutical Enterprise “Zdorovye Narodu” LLC), 22 Shevchenka St., Kharkiv, 61013, Ukraine.
For any questions about data processing, write to fn@zn.kharkov.ua or send a letter to the address above.
What data we process
About the patient: initials, year of birth or age, sex, height and weight if needed; information about the state of health related to the reported case: the side effect, its course and outcome, including the date of death if given; other diseases, pregnancy or breastfeeding if given; the medicines used and whether a doctor prescribed them.
About the reporter: name, qualification, specialty, place of work and the facility's address (for healthcare professionals), phone or e-mail, country.
About a doctor or another healthcare specialist you named: surname, first name, patronymic, specialty, healthcare facility and its address, work phone and e-mail.
Documents and photos, if you added them: medical summaries, test results, photos of the medicine package.
Service information: report number, date and time of sending, the consent edition you agreed to.
We do not ask for the patient's full name, address or medical record number. If they appear on a document or photo, cover them before adding it. If such data still reach us, we will use them for pharmacovigilance only.
Technical data of the request (IP address, time of access) are processed only to protect the form from abuse, are kept in the server logs for a limited time and are not linked to the content of the report.
Why
For pharmacovigilance: to register and assess the report; with your consent, to clarify the circumstances of the case; with your permission, to contact the doctor you named for medical confirmation of the information about the case; to transmit the report to the regulatory authority and to analyse the safety of medicines. The data are not used for any other purpose, including advertising.
On what legal basis
Your consent given in this form, and the obligation to carry out pharmacovigilance imposed on us by the legislation of Ukraine on medicinal products. Data concerning health are processed in accordance with the Law of Ukraine “On Personal Data Protection”.
Information about the doctor or specialist you named is processed to fulfil the obligation to carry out pharmacovigilance. When we first contact them, we will tell them from whom and for what purpose their contact details were received.
To whom the data are transferred
The State Enterprise “State Expert Center of the Ministry of Health of Ukraine” — in the cases and within the time limits set by law.
The server that receives the form may be maintained by technical service providers on our behalf. They have no access to the content of the report: it is encrypted.
The data are not transferred to anyone else, except as provided by law.
How we protect the data
The report is encrypted immediately after it is sent; the server that receives the form cannot read it. It is decrypted only in the company's protected pharmacovigilance system. The encrypted copy on the receiving server is deleted after the report has reached that system and has been included in its backup.
The form does not use cookies. While you fill in the form, the data you enter are kept only in your browser until the tab is closed; files are not kept.
How long the data are kept
For the period set by law for pharmacovigilance documentation. After it expires, the data are destroyed or anonymised.
Your rights
Under the Law of Ukraine “On Personal Data Protection” you have the right:
- to know who processes your data and for what purpose, where they are stored and to whom they are transferred;
- to access your data;
- to demand the correction of inaccurate data;
- to object to the processing or demand that the processing be stopped or the data destroyed if they are processed unlawfully;
- to withdraw your consent;
- to lodge a complaint with the Ukrainian Parliament Commissioner for Human Rights or with a court.
To exercise your rights, write to fn@zn.kharkov.ua and give the report number — this is how we will find your report. We will reply within the time limit set by law.
Withdrawal of consent
You can withdraw your consent by writing to fn@zn.kharkov.ua. Withdrawal does not make the processing that took place before it unlawful.
Limits of the right to erasure. The data of a side-effect report cannot be deleted after it has been transmitted to the regulatory authority: they are part of the documentation we are required by law to keep. This also applies to the reporter's data.
If you report about another person
By reporting about a child or another person, you confirm that you are their legal representative or have their consent to pass on this information.
If you name a doctor or another specialist
Give work contacts only: the phone and e-mail of the facility or official ones. We may contact the patient's doctor only with the permission of the patient or the patient's legal representative given in this form. Without such permission, information about the doctor is not sent.
Changes to this information
This information may be updated. The edition number is shown at the top of the page. Your report is governed by the edition you agreed to when sending it.