PRIVACY NOTICE REGARDING PHARMACOVIGILANCE ACTIVITIES
PRİVACY NOTICE
This Privacy Notice for Pharmacovigilance Activities (“ Privacy Notice”) has been prepared, by Recordati İlaç
Sanayi ve Ticaret Anonim Şirketi (“Recordati” or “ Company”), to inform you about processing of your personal
data within scope of our pharmacovigilance activities in accordance with
the Law on the Protection of Personal Data No. 6698 (“Law
”).
1.
How We Collect Your Personal Data and Legal Reasons
Your personal data can be obtained by automatic means through your calls to
our Company regarding our Pharmacovigilance activities (“ Activities”) or via the “Pharmacovigilance” tab or the
“Contact Us” form on our website at
http://www.recordati.com.tr/Recordati-Ilac/38-bize-ulasin/
or by non-automatic means in the physical environment via mail, verbally,
in writing or electronically.
Within the framework of the requirements of our activities, we process your
personal data within the scope of the fulfillment of our legal obligations
and for the legitimate interests of our company in line with Article 5/2 of
the Law.
Your special category personal health data is processed by the
pharmacovigilance officer, who is under the confidentiality obligation
within the framework of Article 6/3 of the Law, through the above-mentioned
channels for the purposes of protecting public health and preventive
medicine.
2.
Your Processed Personal Data and Purposes of Processing
During our pharmacovigilance activities, we collect the name of the
reporter who made the notification, his/her contact information and the
information of the organization he/she is affiliated with. Also, additional
personal data related to the medical history and health of the person
experiencing the adverse event may also be collected during the processing
of adverse events, if necessary.
We process the personal data your shared with us for the purposes of
recording and filing reports for the suspicious adverse effects, adverse
effects and serious adverse effects, making the relevant notifications
stipulated in the legislation, carrying out activities for the detection,
evaluation, identification and prevention of other potential problems
related to drugs, creating and finalizing your request and complaints
regarding our products, making suspicious counterfeit drug notifications,
developing our products and making necessary studies so that you can
benefit from our products in a better way, recording all conversations for
the purpose of ensuring service and transaction security, monitoring the
content of the communication as required or mandated by legal regulations;
protecting the rights, safety, property and operations of the company or
our subsidiaries, you or third parties and, if necessary, exercising our
right of defense and responding to requests from official authorities or
communication issues.
3.
Transfer of Your Personal Data to Third Parties and/or Abroad
In line with the processing purpose or purposes mentioned above, your
Personal Data can be transferred within the framework of the personal data
transfer conditions specified in Article 8 and Article 9 of the Law to
third parties, located in the country and/or abroad, from which we receive
services such as storage, archiving, information technology, our service
providers, legally authorized public institutions, especially the Ministry
of Health, Turkey Pharmaceuticals and Medical Devices Agency and TÜFAM, our
group companies from which we receive service within the scope of the work,
business partners and other health authorities. In addition, your processed
personal data can be anonymized and entered into the database of the World
Health Organization within the scope of the Pharmaceutical Monitoring and
Cooperation Program.
We may also need to report your personal data to health authorities
residing abroad. However, the notifications will contain detailed
information about the event and a limited amount of personal data. In this
context, the initials of the names and surnames of the patients and
reporters, the age, date of birth and gender information of the patients,
as well as the profession, address and e-mail information of the reporters
can be transferred to the relevant health authorities in order to follow
up.
4.
Storage
Since the information (adverse event reports) about pharmacovigilance is
important for public health, reports should be kept for a minimum of 10
(ten) years after the drug is withdrawn from the market in the last country
where it was marketed.
5.
Access to Your Personal Data and Your Rights Under the Law
Pursuant to Article 11 of the Law, you have the following rights as a
personal data subject:
- To receive information whether your personal data is processed or not,
- If your personal data has been processed, requesting information about
it,
- To learn the purpose of processing your personal data and whether they
are used in accordance with the purpose,
- Knowing the third parties to whom your personal data is transferred, in
the country or abroad,
- Requesting correction of your personal data in case of incomplete or
incorrect processing and requesting notification of the transaction made
within this scope to the third parties to whom the personal data has been
transferred,
- Requesting the deletion or destruction of your personal data in the event
that the reasons requiring its processing cease to exist, despite the fact
that it has been processed in accordance with the provisions of the law and
other relevant laws, and requesting that the transaction carried out in
this context be notified to the third parties to whom the personal data has
been transferred,
- Objecting to the emergence of a result against the person himself by
analyzing your processed data exclusively through automated systems,
- Requesting the compensation of the damage in case of damage due to
unlawful processing of your personal data
Prepare your above-mentioned requests in accordance with the Communique on
Application Procedures and Principles to the Data Controller, and send it
to Çerkezköy Organize San. Bölgesi Karaağaç Mah. Atatürk Cad. No:36 Kapaklı
/ Tekirdağ, to our company via our address. Please confirm the current
application methods from the legislation before applying.
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