KVKKPharmacovigilance Privacy 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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