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.
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
Obmoos 4, 6300 Zug, Switzerland
+41 41 720 2000
Stefanie Ullmann, Global Medical Affairs Lead
Obmoos 4, 6300 Zug, Switzerland
+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
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.
9 IN CONCLUSION
If for some reason you believe that we have not adhered to the foregoing, please notify us by email at firstname.lastname@example.org, and we will do our best to determine and correct the problem promptly.