DATA PROTECTION NOTICE FOR PHARMACOVIGILANCE, MEDICAL INFORMATION & PRODUCT COMPLAINTS

At GENEPHARM S.A (hereafter “GENEPHARM”, “we”, us”), we take data privacy seriously and treat all your personal data in accordance with applicable privacy and data protection laws, including the European General Data Protection Regulation (GDPR), and other applicable local laws that regulate the storage, processing, access and transfer of personal data.

This Data Protection Notice for Pharmacovigilance, Medical Information & Product Complaints (the “Notice”) explains who we are, how we collect and process personal information about you for pharmacovigilance purposes, in order to fulfill our obligation to monitor the safety of all products, as well as for medical information and product complaints’ purposes, and how you can exercise your rights. If you have any questions or concerns about our use of your personal information, then please contact us using the contact details provided at the bottom of this Notice.

Data Controller

“GENEPHARM S.A. PHARMACEUTICAL COMPANY”, with registered address at 18^th km Marathonos Avenue, 153 51, Pallini Attikis, Greece, GCR (GEMI) No. 000276001000 is acting as Data Controller.

General Information

Pharmacovigilance (PV), as defined by the World Health Organization, is "the science and activities related to the detection, assessment, understanding, and prevention of adverse reactions and other drug-related issues." It involves a system for monitoring and evaluating the safety of pharmaceutical products to minimize risks and improve therapeutic outcomes.

Although our products are tested extensively in clinical trials before they are approved, not all of their side effects are known until they are used by many people over time. GENEPHARM is committed to ensuring the safety of its products through continuous monitoring. By encouraging the reporting of complaints and adverse reactions, we collect critical information that aids in evaluating product safety. This feedback enables us to take necessary actions, such as updating usage instructions and improving product safety. The ultimate goal is to enhance therapeutic outcomes for patients and ensure their well-being by addressing any potential risks effectively.

Therefore, at GENEPHARM, processes are in place to ensure that:

• Information sources are systematically monitored,
• Necessary actions are taken when new data emerge, and
• Health professionals, patients, and regulatory authorities are promptly informed of any changes to product characteristics.

This Notice outlines how GENEPHARM collects and processes information provided through various communication channels, such as phone and email, and applies to (a) patients or their representatives reporting safety information including but not limited to adverse events or submitting a quality complaint relating to any one of GENEPHARM’s products, as well as requesting medical information and (b) any individual reporting safety information including but not limited to adverse events or a quality complaint as part of the professional activities of such individual (e.g. healthcare professional such as a medical doctor, a pharmacist, a nurse ).

Which personal data do we process

GENEPHARM gathers and stores the data mandated by pertinent legislation, along with any additional information you choose to share with us, whether in the role of a reporter or a patient. Specifically, if you voluntarily provide such data, the following exemplary categories may be collected and handled:

 - The name and surname of the individual requesting information or reporting adverse events (reporter),

- Patient’s identification data (initials, gender, date of birth, weight, height, country of residence),

- Contact details of the individual requesting information or reporting adverse events (telephone number, area/city, email, capacity),

- Health data (disease, medication, medical tests results, medical history, concomitant medication, use of alcohol or narcotic substances, smoking, pregnancy, allergy, metabolism disorder, surgery etc.),

- The adverse event, the time it appeared, other medical problems,

- Details about the product that caused the side effects, such as the dose received, the reason it was prescribed and/or taken, the treatment start and end dates, the date(s) of occurrence of adverse effects, details (such as dose, reason for prescription, time of treatment, etc.) regarding other drugs or medicinal products that may have been administered at the same time and which you received at the time of the occurrence of the adverse effects, your medical history, your history of taking drugs and pharmaceutical products and other information about the incident and circumstances of occurrence of the adverse effect,

- A summary of other substantial data disclosed during our communication,

-Data related with the request (i.e. date of submission of medical information form, use of products of the Company, number of request).

Purpose and legal basis for processing

Recipients of personal data

Personal data may be accessed by or transferred to:

• our employees (including those in our RA department and Legal department),
• service providers acting on behalf of GENEPHARM, such as IT system and data hosting providers, and adverse event processing service providers. These third parties are contractually obliged to protect the confidentiality and security of personal data, in compliance with applicable law,
• other pharmaceutical companies that are marketing, sales or other licensing partners of GENEPHARM if existing pharmacovigilance obligations for a GENEPHARM product require such an exchange of safety information. These companies will only process the data on our behalf, under our instructions, under our control and in accordance with this Notice,
• healthcare professionals involved in an adverse event, request for information, or complaint,
• health authorities as well as national and/or international regulatory, enforcement, public body or court where we are required to do so by applicable law or regulation or at their request,
• a national and/or international regulatory, enforcement, public body or court where we are required to do so by applicable law or regulation or at their request.

Storage period

As information related to pharmacovigilance is important for public health reasons, the maximum retention period of your data pursuant to the applicable legal framework is 10 years after the expiration of the marketing authorization issued for the medicinal product.

Personal data retained as part of a medical information inquiry are kept for minimum of 10 after receipt of request.

As information related to product complaints and drug safety are important for public health reasons, complaint records, including personal data contained, are kept for minimum of 20 years.

Your rights

We inform you that you may exercise the right of access to your personal data, the right to information, rectification, erasure or restriction of processing, as well as the right to object upon your written request addressed to GENEPHARM  via e-mail at This email address is being protected from spambots. You need JavaScript enabled to view it., under the attention of Data Protection Officer.

Right to lodge a complaint with the Personal Data Protection Authority

If you believe that the processing of your data by GENEPHARM violates the provisions of Regulation (EU) 2016/679 and the Greek legislation (Law 4624/2019) you have the right to lodge a complaint before the Personal Data Protection Authority (This email address is being protected from spambots. You need JavaScript enabled to view it.).