EN DE ES FR IT Primary Menu Drug Safety Reporting Privacy Policy PRIMEX PHARMACEUTICALS DRUG SAFETY REPORTING PRIVACY POLICY Primex Pharmaceuticals consisting of Primex Pharmaceuticals Oy and its affiliates Primex Pharmaceuticals AG and Giovanni Ogna e Figli S.r.l (“Primex”, “we”, “us” or “our”) Your privacy is important to Primex and accordingly, we protect the personal data you share with us. To protect your privacy, Primex follows applicable law and EU best practices for privacy and data protection. This Privacy Policy contains information regarding the processing of your personal data for Drug Safety, Medical Information and Product Quality purposes which Primex processes as a controller within the meaning of the General Data Protection Regulation (“GDPR”). 1 CONTACT PERSONS IN MATTERS RELATED TO THE PROCESSING OF PERSONAL DATA FOR DRUG SAFETY PURPOSES Drug Safety and Product Quality Tomaso Dameno, Head of Operations Primex Pharmaceuticals Obmoos 4, 6300 Zug, Switzerland export@primexpharma.com +41 41 720 2000 Medical Information Stefanie Ullmann, Global Medical Affairs Lead Primex Pharmaceuticals Obmoos 4, 6300 Zug, Switzerland medicalinfo@primexpharma.com +41 41 720 2000 2 THE PURPOSE FOR PROCESSING OF PERSONAL DATA The purpose for processing the personal data you provide through the Primex Drug Safety reporting channels is to fulfil Primex’s legal pharmacovigilance responsibilities in relation to drug safety reporting and monitoring of the safety profiles of Primex’s products as required by applicable legislation. Pharmacovigilance means the science and activities relating to the detection, assessment, understanding and prevention of adverse reactions and other medicine-related problems. In addition, Primex will process your personal data if you contact us or one of our affiliates or commercial partners with a medical information request regarding one of our products, in order to be able to respond to your question and/or to fulfil our drug safety responsibilities. Primex must process your personal data due to its responsibilities in the field of product quality, complaint handling and risk management based on applicable product quality legislation for the purpose of investigating the quality defects and complaints and putting in place appropriate preventative actions. 3 LEGAL BASIS FOR PROCESSING The legal basis for processing of personal data is compliance with Primex’s legal obligations based on binding law (EU General Data Protection Regulation Article 6.1.c). 4 THE PERSONAL DATA WE COLLECT The following data may be collected: regarding the patient: gender, age, initials, height and weight, medical condition, description of adverse event, relevant concomitant medication, pregnancy information when relevant regarding the reporter/complainant: name, status as a health professional, contact details such as e-mail, phone number, address, institute or organization. 5 SOURCES OF INFORMATION Primex receives notifications of suspected adverse events, medical information requests and feedback on quality and complaints directly through its reporting channels, as well as through its affiliates, service-providers or commercial partners, who have received reports from regulatory authorities, healthcare professionals or patients. 6 TRANSFERS OF PERSONAL DATA 6.1 Why we transfer or disclose your personal data We share your information with our affiliates and third parties, including commercial partners and service providers who assist Primex in pharmacovigilance processes such as receipt and follow-up of reported adverse events, reporting and signal evaluation. Primex requires that all these third parties agree to process your personal data in accordance with this Privacy Policy. We are also obligated to submit the data to the national competent authorities as well as to EMAs and other competent authorities’ databases for managing and analysing information on suspected adverse reactions. If ownership or control of Primex or any part of our products, services or assets changes, we may transfer your personal data to any new owner, successor or assignee, in which case we would require the new owner, successor or assignee to treat your personal data in accordance with this Privacy Policy. Primex will not disclose the collected data for commercial purposes. 6.2 International transfers of personal data We or our partners may, in accordance with applicable legislation, process personal data anywhere in the world and thus transfer the personal data also outside EU or EEA area. In regard transfers of personal data to countries where the local data protection legislation does not provide adequate level of data protection, the transfers are based on appropriate safeguards, such as standard contractual clauses approved by the European Commission or a competent supervisory authority. To learn more about the appropriate safeguards we use, please send us an email at the email address set out above 7.2 RETENTION OF PERSONAL DATA Based on the provisions of compelling legislation, Primex has to retain the information regarding safety of medicinal products, including personal data, for at least 10 years after the marketing authorisation for the product in question has ceased to exist. Primex is obliged to store PSMF-related data for at least five years after the system as described in the PSMF has been formally terminated by the marketing authorisation holder. Primex is obliged to store product quality and feedback related information for a period of at least 5 years or longer if required by applicable legislation. 8 DATA SUBJECT RIGHTS You have the right to access the personal data about yourself recorded in this register and to request correction, completion or deletion of any incorrect, unnecessary or incomplete personal data or to request us to restrict the processing of your personal data. For further information on the rights of the data subject, please refer to Primex Privacy Policy. 9 IN CONCLUSION We reserve the right to update and modify this privacy policy. Unless otherwise provided by mandatory applicable legislation, we will not personally post changes to this Drug Safety Reporting Privacy Policy to the data subjects in person, and therefore we prompt you to check this policy from time to time for possible changes. If for some reason you believe that we have not adhered to the foregoing, please notify us by email at export@primexpharma.com, and we will do our best to determine and correct the problem promptly. Primex Pharmaceuticals Privacy Policy (Final version 12 June 2019) TOP © 2018 Primex Pharmaceuticals. All Rights Reserved. Privacy Policy | Conditions of Use | Drug Safety Reporting Privacy Policy