Privacy Policy – Pharmacovigilance and Materialovigilance

Sedana Medical always strive to protect your personal data and to ensure patient safety in the best way possible. This Privacy Policy explains which personal information we collected and process about you in order for Sedana Medical to fulfill its legal requirements to monitor the safety of all medicines we market. This policy also explains your rights that you have under the EU General Data Protection Regulation 2016/679 (GDPR).

How is your personal data used?

All personal data are processed exclusively for pharmacovigilance and materialovigilance purposes and only where relevant and appropriate to document, assess and report your adverse event properly in accordance with our legal obligations.

As Sedana Medical is obliged to take detailed records of every adverse event reported to us, for us to be able to evaluate and compare with other adverse events recorded about the product, we need to process necessary personal data. The personal data that we collect and process about you may include:

patient name and/or initials;
date of birth and age;
gender;
details of the product causing the reaction, including the dosage you have been taking or were prescribed, the reason you have been taking or were prescribed the product and any subsequent change to your usual regimen;
details of other medicines or remedies you are taking or were taking at the time of the reaction, including the dosage you have been taking or were prescribed, the period of time you were taking that medicine, the reason you have been taking that medicine and any subsequent change to your regimen;
details of the adverse event you suffered, the treatment you received for that event, and any long‐term effects the event has caused to your health; and
other medical history, including documents such as lab reports, medication history and patient history.

Some of this information may be considered as sensitive personal data. This includes any information that tells us about your, health, ethnicity, religion, or sexual life.

Sedana Medical is legally required to ensure that adverse events are traceable and available for follow-up. Therefore, we both collect personal data about the person who is subject to an adverse event report, as well as the person or third party making the report. The personal data that we collect and process about you when you make a report may include:

name;
contact details, such as your address, email or phone number;
profession (this information may determine the questions you are asked about an adverse event, depending on your assumed level of medical knowledge); and;
relationship with the subject of the report.

Legal basis for processing your personal data

The legal basis for the processing of your personal data, as described in this policy, is Sedana Medical´s legal obligation to comply with applicable pharmacovigilance laws.

Keeping your personal data secure

Sedana Medical has taken appropriate technical and organizational measures to ensure that the data are protected against destruction through accident, against any modification, unauthorized circulation of or unauthorized access to the data, as well as any other kind of unauthorized processing of the data.

How we share your personal data

We share your information with Sedana Medical’s affiliates and third parties, including service providers who may assist in the pharmacovigilance processes. This includes receipt and follow-up of reported adverse events, regulatory reporting and signal evaluation. All these companies are bound by privacy obligations set forth by contract and/or law, and will only process your personal data in accordance with this privacy policy.

We are also obligated to submit the data to the national competent authorities, including competent authorities’ databases for managing and analyzing information on suspected adverse reactions. Additionally, your personal data may be disclosed to a third party if we are required to do so because of an applicable law, court order or governmental regulation, or if such disclosure is otherwise necessary in support of any criminal or other legal investigation or proceeding here or abroad.

Transfers of your personal data outside the EU/EEA

Some recipients of personal data as stated above may reside outside the European Union (EU) or the European Economic Area (EEA). The level of legal protection for personal data may differ and not provide the same level of protection as the data protection laws in the EU/EEA or of the country in which you live. In case of such transfer, Sedana Medical will take appropriate measures to keep your information secure. You may contact us, see contact details below, if you have any questions about the measures used to safeguard your personal data transferred outside the EU/EEA.

Retention period of your personal data

We will use and store your personal data in accordance with legal requirements governing storage and reporting of pharmacovigilance related information. Such requirements oblige us to store the information for at least ten years after the end of the expiration of the marketing authorization or longer if required by national legislation.

Your rights

You are entitled to receive information about how Sedana Medical process your personal data, as well as to request a copy of your data if you would like to know what personal data we process about you. You may also request Sedana Medical to complete or correct any inaccurate personal data held about you, or to correct or delete any personal data that is erroneous, unnecessary or incomplete or to request Sedana Medical to restrict the processing of your personal data. You can make such a request by contacting us at gdpr@sedanamedical.com or via the contact information provided below.

Security measures

We have taken a number of security measures to ensure that the personal data we keep is secure. For example, access to areas where personal data is stored is limited to our employees and service providers who require it in the course of their duties and who are informed of the importance of maintaining the security and confidentiality of the personal data we keep. We maintain appropriate safeguards and security standards to protect your personal data against unauthorized access, disclosure or misuse. We also monitor our systems to discover vulnerabilities in order to protect your personal data.

Contact details

If you have any questions regarding Sedana Medical processing of your personal data, please contact our Data Responsible at: gdpr@sedanamedical.com

If you have any questions regarding pharmacovigilance please contact our Pharmacovigilance Manager at: safetyandcomplaints@sedanamedical.com