CLARIFICATION TEXT ON PROCESSING OF PERSONAL DATA WITHIN THE SCOPE OF SIDE EFFECT NOTIFICATIONS
Proceutica İlaç Pazarlama ve Danışmanlık Anonim Şirketi (“Proceutica”) would like to inform you about the processing activities it will carry out under the conditions detailed below, in accordance with the Law on the Protection of Personal Data No. 6698 (“KVKK”) and secondary legislation based on the KVKK and the decisions of the Personal Data Protection Board (“Data Protection Legislation”) and other legislation in force in the Republic of Turkey, regarding your personal data that will be processed within the scope of your side effect notifications, which are all kinds of information about you that determine or make your identity determinable.
Proceutica is obliged to carry out activities related to the detection, evaluation, definition and prevention of side effects that may arise during the use of medicines and other possible problems related to medicines (“Pharmacovigilance”).
When reporting side effects for pharmacovigilance purposes, we may need to collect additional personal data related to the medical history and health of the person experiencing the side effect, in addition to the personal data of the reporter. In this context, we kindly request our reporters to direct the patients to whom they have reported side effect information to this information text. This information text is always accessible on our website.
1. Data Controller:
The information regarding the data controller of your personal data to be processed within the scope of your Side Effect Notifications is as follows:
Proceutica İlaç Pazarlama ve Danışmanlık A.Ş.
Address: Huzur Mahallesi Metin Oktay Caddesi Nurol Life Blok No:3 İç Kapı No:49 34396 Sarıyer / İstanbul
E-mail: kvk@proceutica.com.tr
Phone Number: +90 212 843 47 44
2. Your Personal Data to be Processed
As Proceutica, the personal data we process within the scope of your notifications made through the Side Effect Notification Form is as follows:
I. Personal Data and Data Categories Regarding the Reporter
Data Categories | Personal Data to be Processed |
Identity Information | Initials of Name and Surname |
Contact Information | Phone Number, Address, e-Mail |
Professional Experience | Profession, Institution and Department |
Other | Country of Operation |
II. Personal Data and Data Categories Regarding the Patient
Data Categories | Personel Data to be Processed |
Identity Information | Initials of Name and Surname, Gender, Date of Birth |
Contact Information | Phone Number |
Health Information | Pregnancy Information, Height and Weight Information, Experienced Side Effects |
We would like to remind you that you should not share your personal data and/or special personal data (e.g. race or ethnic origin, political views, religious or philosophical beliefs, physical or mental health, genetic/biometric data, association or union membership, dress code, sexual life or tendency, criminal conviction and security measures related data and criminal record) other than those requested by us when contacting us through our Side Effect Notification Form or via e-mails you send.
Personal Data of Third Parties
If you wish to share personal data that does not belong to you but belongs to third parties within the scope of your side effect notification, you agree that you have informed the real persons who are the subjects of this personal data about the scope of processing activities to be implemented by Proceutica with the sharing you will make. Please make sure that the aforementioned requirements are met when receiving personal data of third parties that you will share, otherwise do not share personal data of third parties with Proceutica in any way.
3. Purpose and Legal Basis of Processing Personal Data Relating to Patients
I. Purpose and Legal Reasons for Processing Personal Data Regarding the Rapporteur
Processed Data Category | Purpose of Processing Data | Legal Reason of Data Processing |
Identity Information, Contact Information, Professional Experience Information |
| According to Article 5 (2) (ç) of the KVKK; Processing is necessary for the data controller to fulfill its legal obligation.
|
II. Purpose and Legal Basis of Processing Personal Data Regarding the Patient
Processed Data Category | Purpose of Processing Data | Legal Reason of Data Processing |
Identiy Information, Contact Information |
|
|
Health Information |
Your special personal data that you have provided by filling out the Side Effect Notification Form or sending via e-mail will be processed for the purposes of protecting public health and preventive medicine as stated in the third paragraph of Article 6 of the KVKK and based on this article; and your general personal data will be processed based on the legal reason of “being mandatory for the data controller to fulfill its legal obligation” as stated in subparagraph (ç) of the second paragraph of Article 5 of the KVKK.
III. Method of Personal Data Processing Activity
Your personal data is collected through the “Side Effect Notification Form” on our website, phone calls you will make with us through our call center, e-mails you will send to our address proceutica@deltapv.com dedicated to side effect notifications, and information and documents you send to us through physical mail.
IV. Transfer of Personal Data
Your personal data will be used to fulfill the legal obligations stipulated in the legislation regarding the monitoring of drug safety and may be shared with the Turkish Medicines and Medical Devices Agency. This data may also be entered into the database of the World Health Organization by making it anonymous within the scope of the Drug Monitoring and Cooperation Program.
Proceutica may share your personal data with its business partners and service providers (suppliers, legally authorized institutions and organizations and private law legal entities) in order to fulfill the requirements of the Pharmacovigilance legislation. Your personal data within the scope of your side effect notification must also be reported to health authorities around the world. However, these notifications include detailed information about the side effect, but only a limited amount of personal data:
- Patients: Information including age or date/year of birth, gender, patient initials (patient name is not stated explicitly)
- Reporter: Information such as name, profession, first letters of first and last name, address, e-mail, telephone number provided for the institution to follow up with the reporter.
The side effect notification form you have filled out on our website will be forwarded to our common address proceutica@deltapv.com with our pharmacovigilance services business partner Delta PV İlaç Danışmanlık Sağlık Ürün ve Hizmetleri Ticaret Anonim Şirketi; Your calls to our 0 850 480 77 76 line for side effect notifications will be directed to Delta PV İlaç Danışmanlık Sağlık Ürün ve Hizmetleri Ticaret Anonim Şirketi's +90 216 385 93 33 telephone line.
Your personal data that you share with us through the forms on our website or through the e-mails you send to our e-mail addresses may be transferred abroad due to the fact that the data storage systems of our communication companies and cloud service providers, whose e-mail infrastructure and related services we benefit from, are located abroad. We act in accordance with Article 9 of the KVKK in the transfer of your personal data abroad.
V. Storage of Personal Data
Your personal data within the scope of your side effect notification will be stored only for the period required for the purposes explained in this text or for the periods foreseen to comply with legal regulations. Due to its importance in terms of public health, it is necessary to store these notification reports for a minimum of 10 years after the drug is withdrawn from the market in the last country where it was marketed.
VI. Your Rights Regarding Your Personal Data
In order to exercise your rights under Article 11 of the KVKK within the scope of the legislation on the protection of personal data, in accordance with the “Communiqué on the Procedures and Principles of Application to the Data Controller”;
- You can apply in writing to the address “Huzur Mahallesi Metin Oktay Caddesi Nurol Life Blok No:3 İç Kapı No:49 34396 Sarıyer / İstanbul”,
- by sending an e-mail to kvk@proceutica.com.tr from your previously notified e-mail address and registered in our systems, or
- by sending an e-mail to proceuticailac@hs03kep.tr from your registered e-mail address.
If your application requires an additional cost, you may be requested to pay the fee in the tariff determined by the Personal Data Protection Board.
Last Updated Date: 2/12/2024
