CIBIUS COMPANY – FZCO (“CIBIUS”), as a marketing authorisation holder, is required to collect, assess, process, retain and, where applicable, report information concerning the safety of its medicinal products in order to comply with applicable pharmacovigilance requirements.

Personal data processed for pharmacovigilance purposes

When you report a suspected adverse reaction or provide other safety information, CIBIUS may process personal data relating to:

• the person reporting the information, including name or initials, contact details, country and professional status, where provided;
• the patient, including initials or other limited identifiers, age or age group, sex, country, relevant medical history and other health-related information;
• the medicinal product concerned, including product name, dose, route of administration, treatment dates, batch number and other product-related information;
• the suspected adverse reaction, medical event, outcome, laboratory or diagnostic information, concomitant treatment and other information relevant to the safety assessment;
• follow-up information and correspondence relating to the report.

Please do not provide passport numbers, national identification numbers, full medical record numbers or other excessive identifying information unless such information is specifically required.

Purpose of processing

CIBIUS processes pharmacovigilance data for the purposes of:

• receiving and recording reports of suspected adverse reactions and other safety information;
• assessing the validity, completeness and medical significance of reports;
• contacting the reporter, where appropriate, to obtain additional information;
• detecting, assessing and managing safety signals;
• evaluating the benefit-risk profile of medicinal products;
• fulfilling regulatory reporting and other pharmacovigilance obligations;
• responding to requests from competent authorities;
• maintaining pharmacovigilance records and ensuring traceability, quality control, auditability and inspection readiness.

Recipients of information

Where necessary for pharmacovigilance purposes, relevant information may be shared with:

• competent health and regulatory authorities;
• CIBIUS pharmacovigilance personnel and other authorised employees;
• pharmacovigilance service providers, medical reviewers, database providers and other authorised contractors acting on behalf of CIBIUS;
• business partners or other marketing authorisation holders where pharmacovigilance responsibilities are shared by contract;
• other parties where disclosure is required by applicable law or necessary for the proper performance of pharmacovigilance obligations.

Where possible and appropriate, directly identifying information is limited, coded or pseudonymised before disclosure.

International transfers

Because pharmacovigilance activities may involve competent authorities, service providers or business partners located in different countries, personal data may be transferred outside the country in which the report was submitted.

CIBIUS will implement appropriate organisational, contractual and technical measures for such transfers in accordance with applicable data protection requirements.

Retention of pharmacovigilance information

Pharmacovigilance data and documents are retained for the period required by applicable pharmacovigilance legislation.

For medicinal products authorised in the Eurasian Economic Union, pharmacovigilance data and documents relating to authorised medicinal products are retained by the marketing authorisation holder for at least 10 years after expiry of the relevant marketing authorisation, unless a longer retention period is required under applicable national legislation.

Because CIBIUS has legal obligations to maintain pharmacovigilance records, certain information may not be deleted on request where continued retention is required by applicable law or necessary to demonstrate compliance with pharmacovigilance obligations.

Your rights

Subject to applicable data protection legislation, you may have rights relating to your personal data, including the right to request access to, correction of or restriction of processing of your personal data.

Some rights, including deletion, may be limited where CIBIUS is required to retain information in order to comply with legal pharmacovigilance obligations.

Requests concerning personal data may be submitted to:

Privacy / Data Protection: info@cibiusco.com

Pharmacovigilance: pv@cibiusco.com

Security and confidentiality

CIBIUS applies organisational and technical measures designed to protect pharmacovigilance information against unauthorised access, disclosure, loss, alteration or destruction and limits access to personnel and service providers who require such access for authorised purposes.

Additional information

The processing of pharmacovigilance data is distinct from the use of personal data for marketing or promotional purposes. Information submitted for pharmacovigilance purposes will not be used for direct marketing solely because a person has submitted a safety report.

CREDITS

Published by Cibius Company.

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