Privacy Policy
Privacy Notice for Adverse Event Report, Complaints and Queries
Last Updated: November 11, 2025
INTRODUCTION
This Privacy Notice is for individuals who report adverse events, submit complaints or request medical information, or are the subject of such reports/submits/requests.
This Privacy Notice is provided by Celltrion Healthcare New Zealand, Ltd. (hereinafter "Celltrion" or "we") and its affiliates to explain who we are, how we collect, share, and use personal data about you (hereinafter "you" or "user"), as well as how you can exercise your privacy rights. If you have any questions or concerns about our use of your personal data, or would like to exercise any of your rights — including, but not limited to, objecting to the processing of your personal data in the ways that we describe here — then please contact us using the details provided at the end of this Privacy Notice.
Celltrion does its best to protect your privacy rights.
WHO WE ARE
Celltrion Healthcare New Zealand Limited is a member of the global pharmaceutical group of companies the ultimate parent company of which, Celltrion, Inc., is headquartered in Incheon, Republic of Korea (South). For more information about Celltrion, Inc.’s group of companies, please visit https://www.celltrion.com. Celltrion Healthcare New Zealand, Ltd. is the controller and responsible for this website and when we use Celltrion Healthcare, “we”, “us” or “our” we refer to the relevant company responsible for processing your Personal Data.
Celltrion Healthcare New Zealand Limited has registered offices in New Zealand: Biz Solutions Limited, Level 1, 46 Stanley Street, Parnell, Auckland, 1010.
PERSONAL DATA
We do not require registration to visit our websites. However, some services may require visitors to provide us with Personal Data, such as contact details and interests.
“Personal Data” may refer to any data that identifies one as an individual or relates to an identifiable individual. We may collect, use, store and transfer different kinds of Personal Data about you or individuals about whom you are contacting us, such as:
- Information regarding individuals that report adverse events or make medical information queries or product quality complaints, such as healthcare professionals and caregivers. It includes your name, phone number, email and/or postal address, and place of work (for healthcare professionals);
- Information about the patient, including name, hospital record numbers, age, date of birth, sex, weight, height, race, whether pregnant and/or breastfeeding, and strictly necessary occupational data for the evaluation of the adverse event; or
- Strictly necessary or relevant data, for the purposes described in this Privacy Notice, refers to patient health or lifestyle data including, but not limited to, the nature of adverse effects, examination results, personal or family medical history, diseases or associated events, risk factors, information about the use of medicines and therapy management, physical exercise, diet, eating behavior, sexual life/contraception, and consumption of tobacco, alcohol, and drugs.
If you are a Healthcare Professional ("HCP"), we may request additional Personal Data related to our professional interaction with you. HCP refers to any member of the medical, dental, pharmacy, or nursing professions or any other person who, in the course of his or her professional activities, may prescribe, purchase, supply, or administer a medicinal product.
Additional Personal Data includes, but is not limited to:
- Professional biography/credentials;
- Data related to licenses, specialties, professional affiliations, publications, credentials, and other occupational achievements; or
- Data related to your use of our products, your interactions with us, and services for those whom you care for.
If we ask you to provide any other personal information not described above, then the specific information requested and the reasons why we require them will be made clear to you at the point we collect your personal information
Providing us with, or giving us permission to collect, any Personal Data relating to individuals other than yourself requires you to have valid authority to do so pursuant to relevant legislation.
HOW WE COLLECT YOUR PERSONAL DATA
We use different methods to collect Personal Data from and about you including through:
- Your interactions with us. You may give us your Personal Data by filling in online forms or by corresponding with us by post, phone, email or otherwise, including but not limited to when you give us feedback or contact us.
- Third parties or publicly available sources. We will receive Personal Data about you from various third parties such as healthcare professionals, distributors, regulatory authorities, or other individuals reporting on your behalf. Health data is collected in connection with adverse event reporting, including regulatory databases where such reports are made.
WHAT HAPPENS IF YOU DO NOT PROVIDE YORU PERSONAL INFORMATION TO US?
When reporting an adverse event or filing a complaint, certain Personal Data may be required to assess, respond to, and report the matter in compliance with legal and regulatory obligations. If you choose not to provide necessary information, we may be unable to fully investigate the matter or meet reporting obligations to competent authorities, which could hinder our ability to ensure safety, resolve the issue, or fulfil our legal responsibilities.
HOW WE USE PERSONAL DATA
We use Personal Data in order to:
- Monitor the safety of medicinal products and medical devices, which includes detecting, assessing, following up on and preventing adverse events, and reporting adverse events to health authorities;
- Respond to queries regarding medical information including, but not limited to, relation to availability of products, clinical data, dosing and administration, formulation and stability, and interactions with other drugs, foods, and conditions;
- Respond to quality complaints regarding our products, such as any fault of quality and/or effectiveness, stability, reliability, safety, performance, or usage;
- Answer other questions or requests and improve our products and services;
- Comply with our policies and local legal, regulatory, and compliance requirements; or
- Conduct audits and defend litigation.
The Personal Data that you and other individuals provide may be aggregated. We may use and disclose such aggregated data for any purpose. Aggregated data does not personally identify you or any other individual.
HOW WE DISCLOSE PERSONAL DATA
We do not share or transfer personal data to third parties other than those indicated in this Privacy Notice.
Personal data may be accessed by or transferred to:
- Our employees (including those at Medical, Quality, Legal and Compliance Departments) and other Celltrion Group (especially Celltrion Inc., the manufacturer of our products)
- Other pharmaceutical and medical device companies if the adverse event, request for information, or complaint relates to one of their products
- Service providers acting on behalf of us and our subsidiaries/affiliates, such as IT system and data hosting providers, and adverse event processing service providers. These third parties are contractually and legally obliged to protect the confidentiality and security of personal data, in compliance with applicable law
Personal data may be shared with:
- Healthcare professionals involved in an adverse event, request for information, or complaint
- 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; Including but not limited to:
- The European Medicines Agency (EMA) which controls the EudraVigilance database (for more information visit https://www.ema.europa.eu);
- The U.S. Food and Drug Administration (FDA) which controls the Adverse Event Reporting System (for more information visit https://open.fda.gov/data/faers/) - The Center for Adverse Reactions Monitoring (CARM) or New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE), and
- The Korea Institute of Drug Safety & Risk Management (KIDS) which controls the Korea Adverse Event Reporting System (for more information visit https://kaers.drugsafe.or.kr/)
- To any other person with your consent to the disclosure.
We may also disclose your Personal Data as necessary or appropriate:
- To comply with applicable law, as well as our regulatory and industry monitoring and reporting obligations (including laws outside your country of residence);
- to respond to requests from both public and government authorities (including authorities outside your country of residence);
- to cooperate with law enforcement; or
- for other legal purposes.
INDIVIDUAL RIGHTS
Subject to certain grounds for refusal set out in the Privacy Act, you have the right to access your readily retrievable personal information that we hold and to request a correction to your personal information. Before you exercise this right, we will need evidence to confirm that you are the individual to whom the personal information relates.
In respect of a request for correction, if we think the correction is reasonable and we are reasonably able to change the personal information, we will make the correction. If we do not make the correction, we will take reasonable steps to note on the personal information that you requested the correction.
To invoke any of these rights, please contact us by using the contact details at the bottom of this Privacy Notice. Please keep in mind that we may ask for additional information to verify your identity and where you are located when processing your request as well as information about how you have previously interacted or engaged with us.
If you have given your consent to a certain purpose, you can withdraw your consent at any time. Please keep in mind that withdrawal will not have retrospective effect, and may affect what services we can provide you with.
DATA SECURITY
We take your privacy very seriously and use reasonable organizational, technical, and administrative measures in order to protect your Personal Data. We work hard to protect you and your information from unauthorised access, alteration, disclosure, or destruction and have several layers of security measures in place, this includes encrypting your Personal Data in transit and at rest.
DATA RETENTION PERIOD
We will retain your Personal Data for as long as needed or permitted in light of the purpose(s) for which it was obtained and as outlined in this Privacy Notice.
When we have no ongoing legitimate business need to process your personal information, we will either delete or anonymize it or, if this is not possible (for example, if your personal information has been stored in backup archives), then we will securely store your personal information and isolate it from any further processing until it can be safely deleted.
Please note that we may need to retain certain types of Personal Data for recordkeeping or legal or regulatory compliance purposes.
INTERNATIONAL DATA TRANSFERS
Your Personal Data may be transferred to, and processed in countries other than the one in which you are resident. These countries may have data protection laws that are different from the laws in your country.
The servers of this website are located in the Republic of Korea (South). We may transfer your Personal Data with legitimate purpose to other members of the Celltrion group of companies, third party service providers, and business partners located around the world.
Whenever we transfer your personal data out of New Zealand, we ensure that a similar degree of protection is afforded to and that your Personal Data will remain protected in accordance with this Privacy Notice.
As of the last updated date of this Privacy Notice, the UK’s Information Commissioner's Office (the ICO) and the European Commission have adopted an adequacy decision for Republic of Korea (South Korea), which means that free unrestricted transfers of personal data from the those jurisdictions to private and public entities in South Korea will be permitted (including remote access from South Korea), and the recipient in Republic of Korea is subject to comparable safeguard to the New Zealand’s Privacy Act. Before disclosing any personal information to an overseas recipient, we also take steps reasonable to comply with the is subject to the Privacy Act.
Appropriate safeguards have also been implemented with our third-party service providers and partners as required.
USE BY MINORS
Our websites and online services are not intended to be used by anyone under the age of 18.
THIRD PARTY LINKS
This website includes links to third-party websites. Clicking on those links may allow third parties to collect or share data about you. We do not control these third-party websites and are not responsible for their privacy statements. When you leave our website, we encourage you to read the privacy policy of every website you visit.
LODGING A COMPLAINT
If you want to contact us about any of your rights or complain about how we use your information, you can contact us on the details set out below. We’ll do our best to help but if you are still not satisfied, you can lodge a complaint with the Office of the Privacy Commissioner (Privacy Commissioner).
UPDATES
We may update this Privacy Notice from time to time in response to changing legal, technical, or business developments. When we update our Privacy Notice, we will take appropriate measures to inform you with the significance of the changes we make. We will obtain your consent to any material Privacy Notice changes if and where this is required by applicable data protection laws. This Privacy Notice was last updated as of the "Last Updated" date shown above.
CONTACT US
If you have any questions or concerns about our use of your personal information, please contact our data protection officer using the following details: DPO.CTHC@celltrion.com