Data Protection Notice for the Service of Medical Information and Vigilance
The Company Creative Pharma & HR Services S.M.S.A. (hereafter the “Company” or “us”) is committed to complying with the laws governing its operation, to keep good practices and to provide high quality services.
The protection of your personal data is a priority for us. Learn more about how the Company processes your personal data in the context of the Medical Information and Vigilance Service for pharmaceutical products, medical devices, cosmetics and food supplements by reading the following notice.
What is Medical Information and Vigilance Service
The Medical Information and Vigilance Service has a dual task: on one hand, it provides information to the public on pharmaceuticals, medical devices, cosmetics and food supplements and, on the other hand, it documents reports related to the safety of these products, such as adverse events.
The disclosure of data in the context of the Medical Information and Vigilance Service is performed on a voluntary basis and with the purpose of protecting public health and, in particular, ensuring the quality and safety of such products.
Which of your data we process
The Company collects and retains the data required by the specific legislation governing the operation of the Medical Information and Vigilance Service, as well as any other information you choose to disclose to us. In particular, when disclosed, we will collect and process, the following data, indicatively:
The name and surname of the individual requesting information or reporting adverse events;
Contact details (telephone number, address, email)
Demographics (gender, age, etc.)
Health data (disease, medical examination results, medical history, concomitant medication, use of alcohol or narcotic substances, pregnancy, etc.)
Why do we process your data
We process your data to provide the best possible service and to communicate efficiently with you and exclusively for the following purposes:
Provide Medical Information
We process the data you give us to respond to enquiries and/or complaints and provide you with the information you request. Data collected in the context of the medical information service, including your name and surname, is transmitted to the marketing authorization holder or manufacturer of the product, according to our contractual obligations.
Vigilance for reasons of public interest in the field of public health
When there are reasons of public interest in the field of public health, such as ensuring high standards of quality and safety of medicines or medical devices or other products, we will provide your data to the competent authorities, according to applicable legal obligations, and/or the marketing authorization holder or manufacturer of the product, according to our contractual obligations. The data collected in the context of the medical products safety service are transmitted to the competent authorities in anonymous format. Typically, anonymous data is transmitted to the marketing authorization holder or manufacturer unless, transmission of data including your name and surname, is required for monitoring purposes of the report or based on the contract.
Scientific Research purposes
If you participate in clinical trials, your safety related data is processed for the purpose of conducting the clinical trial. The data collected by the investigators is transmitted pseudonymized to us. We transmit pseudonymized data to the sponsor of the clinical trial, according to our contractual obligations, and to the competent authorities, according to applicable legal obligations.
Legal Obligation
We will collect and retain your data if this is required by law and specific regulations and good practices governing the operation of the Medical Information and Vigilance Service.
Legal Claims
We will retain and process your data to the extent necessary to establish, exercise or defend legal claims against the Company and/or the marketing authorization holder or manufacturer of the product.
Who receives and processes your data
Your data may be accessed by our duly authorized employees, as well as by the marketing authorization holder or manufacturer of the product or the sponsor of the clinical trial (as applicable), the competent authorities and third-party auditors who audit our internal procedures.
For how long do we retain your data
We will retain your data for the duration of our cooperation with the marketing authorization holder or manufacturer of the product and for five (5) years after the end of our cooperation. Similarly, for data collected in the context of clinical trials, we will retain your data for the duration of the clinical trial and for five (5) years after the end of the clinical trial and our cooperation with the Sponsor of the given trial. Upon the end of the retention period, we will transmit your data to the marketing authorization holder, the manufacturer of the product or the Sponsor of the clinical trial respectively and delete it from our records.
Data collected are kept in hard copies and in digital format and with safety at Company’s premises.
Your rights
Our Company ensures your rights with respect to processing of personal data and facilitates that you may exercise them.
You have the right to request:
- Access to your personal data and information regarding the data we process, the purposes of processing, the recipients and the duration of processing.
- Rectification of your personal data if it is inaccurate or incomplete.
- Deletion of your personal data or transmission to third parties, unless their processing is necessary for the exercise of the legal rights of the Company or of third parties, for the fulfillment of a legal obligation, for public interest reasons or for defending our legal rights before judicial or other Authorities.
- Restriction of processing of your personal data only for specific purposes.
- Portability of your data, that is to receive the data you have provided in a structured, commonly used format, or ask to send it to a third party designated by you.
- Withdrawal at any time of your consent for the processing of your personal data when processing is based on consent.
If you have any request or if you wish to exercise any of your rights regarding your personal data, you may contact us to the following contact details:
Creative Pharma & HR Services S.M.S.A.
286 Kifisias Ave., Halandri 152 32, Athens, Greece
Tel.: +30 210 32 59 360
Finally, if you consider that your data protection rights have been violated, you have the right to lodge a complaint with the Hellenic Data Protection Authority (www.dpa.gr).
LAST UPDATED: 13-Jun-2022