Last Updated: February 2023
This Clarification Text has been prepared for the following people:
TRPharm İlaç Sanayi Ticaret Anonim Şirketi (“TRPharm”) is committed to protecting your personal information and being transparent about what is done with the information it collects.
With this notification, you will receive the Personal Data Protection Law No. 6698 and the dated 01.08.2019. Within the scope of the Guide on the Protection of Personal Data in Pharmacovigilance Activities published by the Ministry of Health, Turkish Medical Devices and Medicines Agency, information is provided on how we process your personal information as TRPharm "Data Controller", which is registered as the marketing license holder for the relevant medical product and specified on the patient leaflet.
If you have any other questions about the processing of your Personal Data other than this Clarification Text, you can contact us via info@trpharm.com.
1. Purposes of Data Processing
Your Personal Data may be processed for the following purposes:
1.1. All pharmacovigilance activities required to monitor the safety of medicinal products and medical devices, including detection, assessment, follow-up of adverse events (side effects), prevention of occurrence by other patients and reporting to health authorities;
1.2. Answering questions about a product's market availability, clinical data, dosing and administration, formulation and stability, interactions with other drugs and foods, and medical information pertaining to special populations such as pregnant women;
1.3. Handling quality complaints about our products, such as any defects in quality and/or efficacy, stability, reliability, safety, performance or use
1.4. Conducting non-invasive studies using safety monitoring data to assess the risk of reproductive toxicity where a product can be used during pregnancy; (For this purpose, we may periodically follow up with relevant health professionals to gather information about the outcome of the pregnancy and the development of the child after birth)
1.5. improvement of our products and services;
1.6. teaching or training outside or within TRPharm;
1.7. Providing you with adequate and updated information about the disease, medicines as well as our products and services;
1.8. Answering all your questions and requests;
1.9. Managing incoming calls to TRPharm Contact Center;
1.10. Ensuring compliance and reporting (such as compliance with our policies and local legal requirements, conducting audits and defending litigation);
1.11. Archiving and record keeping
1.12. All other purposes determined by legislation and competent authorities.
2. Legal Reasons for Data Processing
2.1. We will not process the personal data of Relevant Persons unless there is an appropriate justification for this purpose stipulated in the law. We will only process the personal data we collect on the basis of the following legal reasons set forth in Article 5 of the Personal Data Protection Law (referred to as "KVKK");
2.1.1. Necessary to fulfill our legal obligations regarding the safety of medical products and medical devices and our obligations to provide information on these medical products and medical devices,
2.1.2. Protection of public health, necessary for the public interest in the field of public health
2.1.3. Carrying out preventive medicine, medical diagnosis, treatment and care services,
2.1.4. Obtaining your prior consent for side effect reporting process follow-up
2.1.5. It is necessary for our legitimate interests in terms of personal information other than sensitive personal information and does not unduly affect your interests or your fundamental rights and freedoms.
2.2. When processing your personal information for the final purpose, we always try to strike a balance between our legitimate interests and your privacy. Examples of such “legitimate interest” might be data processing activities for the following purposes:
2.2.1. Providing or facilitating the provision of relevant and complete information about our products;
2.2.2. Preventing fraud or criminal activity related to the security of our services and products, as well as our IT systems, architecture and network;
2.2.3. Selling any part of our business or assets, or allowing a third party to acquire all or part of our business or assets;
2.2.4. Achieving our corporate and social responsibility goals.
3. Collected Personal Data and Its Uses
3.1. Information about healthcare professionals who have reported adverse events or a special case scenario (such as overdose, ineffectiveness, pregnancy, exposure to the drug during breastfeeding), information about relatives or medical information inquiries, information about people who have product quality complaints. This data allows us to answer questions and request additional information as needed. The data we collect may include your name, e-mail and/or postal address, telephone number and workplace (for healthcare professionals). If you are a healthcare professional, we may also collect information to verify that you are a healthcare professional;
3.2. Name, hospital registration numbers, age or date of birth, gender, weight, height, whether pregnant and/or breastfeeding, ethnicity (where specific information on ethnicity is included in the Summary of Product Characteristics (SPC)) and occupational data (assessment of adverse event) patient information, including where strictly necessary for and
3.3. When strictly necessary and relevant for the purposes described in this Disclosure Text, the nature of side effects, examination results, personal or family medical history, diseases or related events, risk factors, drug use and treatment management, physical exercise, diet and eating behavior, sexual life/ patient health and lifestyle information, including but not limited to contraception and information on tobacco, alcohol and drug consumption.
4. Accessing and Transferring Personal Data
4.1. Personal data is not shared or transferred to third parties other than those specified in this Clarification Text. Personal data may be accessed or transferred to the following persons:
4.1.1. TRPharm employees (including those in the Patient Safety, Medical Information, Quality Assurance and Legal departments) and other TRPharm Group companies;
4.1.2. Other pharmaceutical and medical device companies, if the adverse event, information request or complaint is related to one of their own products; and
4.1.3. Service providers acting on behalf of TRPharm Companies, such as IT Hosting service providers and other service providers or adverse event processing service providers (especially call centers). The third parties mentioned above are obliged to protect the confidentiality and security of your personal information in accordance with the applicable legislation or contractual relationship.
4.2. Personal data may also be shared with the following persons:
4.2.1. Healthcare professionals involved in an adverse event, request for information or complaint;
4.2.2. T.R. Health authorities, including the Department of Health, the European Medicines Agency (EMA), which controls the EU EudraVigilance database (https://www.ema.europa.eu), and the US Food and Drug Administration (FDA); and
4.2.3. A national and/or international regulatory, enforcement, public institution or court that we need to transfer as required or requested by applicable law or regulation.
4.3. TRPharm may work with a contracted pharmacovigilance service provider that provides pharmacovigilance services. In cases where the relevant institution acts as a data processor under the contract, it processes personal data on behalf of TRPharm in order to perform the pharmacovigilance services it offers. When personal data is collected directly by the contracted pharmacovigilance service organization, the contracted pharmacovigilance service organization often acts as the data controller. In this context, the Personal Data Processing and Protection Policy of the relevant institution is followed.
5. Retention of Personal Data
5.1. Storage Place
5.1.1. Personal data may be processed, accessed or stored in a country other than the country in which you are located and that country may not offer the same level of protection for personal data.
5.1.2. If we transfer personal data to external companies located in other jurisdictions, (i) applying the level of protection required under the data protection/privacy laws applicable to the TRPharm entity; We will protect your personal data by (ii) acting in accordance with our policies and standards and (iii) for TRPharm companies located in the European Economic Area ("EEA"), unless otherwise stated, by transferring your personal data only based on standard contractual clauses approved by the European Commission. You can request additional information regarding international transfers of personal data and obtain a copy of the adequate protection put in place by exercising your rights set out below.
5.1.3. For transfers of personal data within the group, the TRPharm Group has adopted the Binding Corporate Rules – a system of principles, rules and tools established by European legislation to ensure effective data protection measures regarding transfers of personal information outside the EEA.
5.2. Storage Time
5.2.1. The above-mentioned personal information and personal information only for the fulfillment of the purposes specified in this Clarification Text; Turkish
6. Rights of Personal Data Owners
6.1. To access your personal data and request that it be corrected or updated if you think it is inaccurate, outdated or incomplete;
6.2. To request the deletion or restriction of use of your personal data;
6.3. To learn the purpose of processing personal data and whether they are used in accordance with its purpose;
6.4. Object to the processing of your personal data in whole or in part;
6.5. If the processing is based on your consent, you can withdraw your consent at any time without affecting the lawfulness of the processing prior to such consent being withdrawn.
You have the right to use your requests within the scope of Article 11 of the Personal Data Protection Law (referred to as "KVKK"), which regulates the rights of the person concerned, in accordance with the "Communiqué on the Procedures and Principles of Application to the Data Controller". If you have a question or want to exercise your rights set forth in Article 11 of the KVKK, you can send an e-mail to info@trpharm.com with a copy of your ID for identification purposes, or send an e-mail to TRPharm's "Esentepe Mh. Buyukdere Cd. Kanyon Office Block No: 185 Floor: 14 34394 Levent - Şişli İSTANBUL / Turkey” address.
We will only use such data to verify your identity and will not retain these copies after the verification process has been completed.
In any case, in addition to your rights above, you also have the right to file a complaint with the Personal Data Protection Authority. Regarding this Clarification Text. Changes or additions will be made available to you through our usual communication channels (via the contact center or our websites).