{"id":1315,"date":"2024-03-05T13:02:40","date_gmt":"2024-03-05T13:02:52","guid":{"rendered":"https:\/\/devm.kyowakirininternational.com\/?page_id=1315"},"modified":"2026-02-13T13:53:16","modified_gmt":"2026-02-13T13:53:16","slug":"notices","status":"publish","type":"page","link":"https:\/\/kyowakirininternational.com\/noba-en\/notices\/","title":{"rendered":"Notices"},"content":{"rendered":"

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Healthcare Professionals Hub<\/span><\/a><\/p>\n

” content_phone=”<\/p>\n

Healthcare Professionals Hub<\/span><\/a><\/p>\n

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Healthcare Professionals Hub<\/span><\/a><\/p>\n

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Report Adverse Event \"\"<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.24.0″ _module_preset=”default” z_index=”500″ width=”100%” max_width=”100%” min_height=”100px” height=”100px” overflow-x=”visible” overflow-y=”visible” custom_margin=”||||false|false” custom_padding=”|||25px|false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_menu menu_id=”37″ active_link_color=”#ea5504″ dropdown_menu_bg_color=”#5d6164″ dropdown_menu_line_color=”#ff3300″ dropdown_menu_text_color=”#000000″ dropdown_menu_active_link_color=”#ff3300″ mobile_menu_bg_color=”#b4c0c1″ mobile_menu_text_color=”#000000″ logo=”https:\/\/kyowakirininternational.com\/noba-en\/wp-content\/uploads\/sites\/14\/2024\/01\/KyowaKirin_BrandLogo_colorv2-PhotoRoom-1-1024×216.png” logo_url=”https:\/\/kyowakirininternational.com\/noba-en\/” logo_width=”100%” logo_max_width=”17%” show_search_icon=”on” search_icon_color=”#ea5504″ menu_icon_color=”#ea5504″ logo_max_width_tablet=”35%” logo_max_width_phone=”76%” logo_max_width_last_edited=”on|phone” show_search_icon_tablet=”on” show_search_icon_phone=”on” show_search_icon_last_edited=”on|phone” search_icon_color_tablet=”#ea5504″ search_icon_color_phone=”#ea5504″ search_icon_color_last_edited=”on|phone” _builder_version=”4.25.1″ _module_preset=”default” menu_font=”|600|||||||” menu_text_color=”#5d6164″ menu_font_size=”17px” background_color=”RGBA(255,255,255,0)” custom_css_free_form=”.et_pb_menu__icon.et_pb_menu__search-button {||padding: 2% 2% 2% 1%;||||}” global_colors_info=”{}”][\/et_pb_menu][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.24.0″ _module_preset=”default” width=”90%” max_width=”100%” custom_margin=”-25px||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][lwp_divi_breadcrumbs font_icon=”5||divi||400″ link_color=”#5d6164″ separator_color=”#e95505″ current_text_color=”#e95505″ _builder_version=”4.24.0″ _module_preset=”default” module_text_align=”left” background_color=”RGBA(255,255,255,0)” text_orientation=”left” animation_style=”fade” global_module=”1047″ global_colors_info=”{}”][\/lwp_divi_breadcrumbs][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.24.2″ _module_preset=”default” background_color=”#e5e5e5″ global_colors_info=”{}”][et_pb_row _builder_version=”4.24.0″ _module_preset=”default” custom_padding=”||0px|||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.24.2″ _module_preset=”default” header_font=”|700|||||||” header_text_align=”center” header_text_color=”#ea5504″ global_colors_info=”{}”]<\/p>\n

Notices<\/h1>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.24.0″ _module_preset=”default” background_color=”#FFFFFF” global_colors_info=”{}”][et_pb_row _builder_version=”4.24.2″ _module_preset=”default” width=”90%” max_width=”100%” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_accordion open_toggle_text_color=”#000000″ closed_toggle_text_color=”#FFFFFF” closed_toggle_background_color=”#ea5504″ icon_color=”#000000″ module_class=”pa-accordion” _builder_version=”4.27.5″ _module_preset=”default” toggle_text_color=”#FFFFFF” toggle_font=”|700|||||||” background_color=”RGBA(255,255,255,0)” hover_enabled=”0″ border_radii=”on|10px|10px|10px|10px” global_colors_info=”{}” sticky_enabled=”0″][et_pb_accordion_item title=”Kyowa Kirin Privacy Notice for Medical Information, Pharmacovigilance Reports and Product Complaints” open=”on” open_toggle_text_color=”#ea5504″ icon_color=”#000000″ _builder_version=”4.27.5″ _module_preset=”default” background_color=”RGBA(255,255,255,0)” background_enable_color=”on” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n

1. Data controller<\/strong><\/span>
2. Contact Information<\/strong><\/span>
3. Scope of this Privacy Notice<\/strong><\/span>
4. Information we collect and why we collect it<\/strong><\/span>
5. How we use Personal Data<\/strong><\/span>
6. Data retention<\/strong><\/span>
7. How we share Personal Data<\/strong><\/span>
8. International transfers<\/strong><\/span>
9. Your data protection rights<\/strong><\/span>
10. Security<\/strong><\/span>
11. Changes to this Privacy Notice<\/strong><\/span><\/p>\n

1. Data controller<\/strong><\/span>
Kyowa Kirin International plc, and its affiliates, https:\/\/international.kyowa-kirin.com\/ (Kyowa Kirin ,and its affiliates, https:\/\/international.kyowa-kirin.com\/), which has interacted with you or has collected data concerning medical information enquiries, pharmacovigilance reports and product complaints, are the data controllers of your personal data (\u201cKyowa Kirin\u201d, \u201cwe\u201d, \u201cus\u201d, \u201cour\u201d). You can find more information on the relevant local Kyowa Kirin affiliate here.<\/p>\n

2. Contact Information<\/strong><\/span>
If you have any questions regarding this privacy notice or wish to exercise any of your rights, please contact us. You can also contact our Data Protection Officer (if applicable) for your country:
Post: Kyowa Kirin International Ltd, Head Office, Galabank Business Park, Galashiels, TD1 1QH, United Kingdom and marking your query for the attention of The Data Protection Officer
E-mail : KKIDPOoffice@kyowakirin.com
We will use reasonable endeavours to answer your question promptly or resolve your problem.
For more detailed information about Kyowa Kirin\u2019s privacy practices, please refer to our Privacy Notice, available on our corporate website here.<\/p>\n

3. Scope of this Privacy Notice<\/strong><\/span>
This Privacy Notice is intended to explain how we will collect and process your personal data for the purposes of management of medical information enquiries, pharmacovigilance adverse event reports and product complaints (both including product complaints and service complaints (e.g., problem with delivery of the product)) related to Kyowa Kirin medicinal products.
In particular, this notice describes how we collect and use Personal Data to help us fulfil our duty to monitor the safety of all products including medicines we market or have in clinical development (also known as our pharmacovigilance obligations), to handle your medical enquiries appropriately, to manage any complaint you may have about our products and to ensure the quality and safety of all our products.
The notice is also applicable to medical devices since the international (including European) regulations on such products and devices require similar safety and quality monitoring. However, to facilitate the reading only reference to drug safety is made.
This Privacy Notice applies to information we collect from or about you online, by phone, fax, e-mail or post, or as part of the adverse event, the medical enquiry, or the product complaint or relevant regulations applicable to Kyowa Kirin. We may also collect this information about you through specific forms submitted by you on a site that is owned or controlled by Kyowa Kirin.<\/p>\n

4. Information we collect and why we collect it<\/strong><\/span>
A. Medical information enquiries<\/strong>
Any personal data provided by you to Kyowa Kirin which relates to a medical enquiry may be used exclusively to manage your enquiry appropriately, follow up with you to request additional information in order to respond to your enquiry.
Your data will not be used for any other purposes. If you do not wish to provide your personal details to us, we will not be able to contact you back or further deal with your request.
For managing medical information enquiries, we may collect the name and surname of the requestor, their contact details (such as phone number and email address) and their affiliation or profession.
B. Pharmacovigilance Reports<\/strong>
Pharmacovigilance laws require us to take detailed records of any potential adverse event or event that may potentially impact patients’ safety (e.g. Pharmacovigilance Special Situations or Pharmacovigilance-relevant information). This information is collated to be evaldevmed and collated with other recorded potential adverse events or events that may potentially impact patients’ safety about that product and make efforts to prevent similar events from happening in the future.
Please note that if you are a patient on any of Kyowa Kirin’s medications, we may also be provided with information about you, not directly by you but by a third party reporting an adverse event that affected you. Such third parties may include healthcare professionals (HCPs), our partners (e.g. distributors of our products, vendors etc), carers, relatives, other persons linked with you or other members of the public, competent authorities etc.
Any personal data provided by you as a patient or as reporter to Kyowa Kirin, which relates to the reporting of adverse events or other pharmacovigilance related activities, will be collected and used solely for pharmacovigilance management purposes.
The personal data that we may collect about you when you are the subject or the reporter of an adverse event report or Pharmacovigilance-relevant information is the following:
Personal data relating to the Patient:
\u2022 Patient\u2019s name (if patient is the reporter for himself\/herself) or initials (in case the HCP is the reporter);
\u2022 For effective follow-up activities, contact details (such as address, e-mail address, phone number) are requested on a voluntary basis to contact patients, in case the patient is also the reporter;
\u2022 Date of birth\/age\/age group, sex, weight, height;
\u2022 Information about health, ethnic origin; and
\u2022 Medical history and status, which may include but not limited to, for example, include administered treatments, test results, nature of the adverse effect(s), details of other treatments, medicines or remedies taken, personal or family history, sexual life in relation to associated reported events, associated diseases or events, risk factors, genetic data in relation to what is needed for the good use of our products, information on how medicinal products are prescribed and used and on the therapeutic conduct of the prescriber or of the HCPs involved in the management of the disease or adverse health event.
Personal data relating to the Reporter:
\u2022 Reporter\u2019s Name;
\u2022 Contact details (such as address, e-mail address, phone number) needed to perform effective follow-up to ensure complete and accurate data is collected;
\u2022 Profession (if the reporter is an HCP; this information may determine the questions you are asked about an adverse event, depending on your assumed level of medical knowledge); and
\u2022 Relationship with the subject of the report.
C. Product complaints<\/strong>
Any personal data provided by you to Kyowa Kirin which relates to a product complaint will be used solely for the purposes of management of such product complaints.
We may collect the name, contact details of the individual reporting the complaint. As a rule, the complainant is an HCP. In such cases, we may also collect details regarding his\/her affiliation\/profession. To the extent permitted according to local laws to record complaints reported by patients, we do so in accordance with applicable legal limitations so as to ensure that only strictly necessary details belonging to patient-reporter are collected.<\/p>\n

5. How we use Personal Data<\/strong><\/span>
A. Medical information enquiries<\/strong>
Handling of your enquiry is based on our legal obligations and industry regulations to provide a medical information service for our products. We will also rely on our legitimate interests to further store and maintain medical information related data, to the extent required, in a medical information database for future historic reference, record keeping, auditing and compliance purposes as well as for the establishment, exercise or defense of legal claims. The processing of special categories of data, such as health data, is necessary for reasons of public interest in the field of public health.
If your medical information enquiry consists of or requires the further reporting of an adverse event, your data (including special categories of personal data) will be also processed to comply with our legal pharmacovigilance obligations imposed on Kyowa Kirin by European, national and local pharmacovigilance laws and regulations. Also, in case that your medical enquiry consists of a product complaint, your data may be processed to comply with our legal obligations in the context of drug and product safety.
B. Pharmacovigilance Reports<\/strong>
We will collect personal data which relates to the reporting of adverse events or other pharmacovigilance related activities and use such data to investigate the adverse event, to follow-up with the patient, or the patient\u2019s doctor or the reporter, or in general, to collect additional information about the adverse event, to analyze the safety of the product by combining and collating the information from one adverse event with information about other adverse events and to provide relevant pharmacovigilance reports to the competent regulatory authorities in and outside of Switzerland, UK and EEA as necessary, to continuously assess the benefit\/risk ratio of our products.
Processing is necessary for Kyowa Kirin to comply with international, European and local pharmacovigilance-related legal and regulatory obligations. In terms of a follow-up to a Reporter of an adverse event, Reporter\u2019s consent is necessary for the processing of personal data.
The processing of special categories of data, such as health data, is necessary for reasons of public interest in the field of public health and aims to the detection, assessment and understanding of adverse events and any other medicine-related problem as well as to ensure compliance with high standards of quality and safety of health care and medicinal products, in accordance with applicable data protection laws.
C. Product complaints<\/strong>
Processing of personal data provided by you, which relates to a product complaint, might be required for Kyowa Kirin to comply with international, European and local legal obligations in the context of drug quality and safety. The processing of special categories of data is necessary for reasons of public interest in the field of public health and will be used for the evaldevmion, classification, and assessment of the product complaint, to follow up on such requests for healthcare purposes, to request additional information and\/or to respond to you.<\/p>\n

6. Data retention<\/strong><\/span>
A. Medical information enquiries<\/strong>
Personal data retained as part of a medical information inquiry are kept within our system for 3 years. At the end of this period the data will be deleted or archived in an anonymized form.
B. Pharmacovigilance Reports<\/strong>
Mandatory requirements oblige us, as market authorisation holders of products, to keep all product-related documents for at least the time period of the market authorisation, plus 10 years following its expiry, unless an additional territory imposes a longer retention period by regulation such as European Union or national law. At the end of this latest period imposed by a territory, the data will be securely deleted or archived in an anonymized form.
C. Product complaints<\/strong>
As information related to product complaints is necessary to comply with our legal obligations relating to our market authorisation of products, we must retain all product-related documents for at least for one year after expiry of the batch to which it relates or at least five years after certification of the batch by the Qualified Person, whichever is the longer.<\/p>\n

7. How we share Personal Data<\/strong><\/span>
We may disclose your personal information with any member of our group or with selected third parties where we have a legal basis for doing so.
We may share your information with selected third parties including:
\u2022 Kyowa Kirin group: Kyowa Kirin affiliates exchange safety data and collaborate on related, medical information, pharmacovigilance and drug quality and safety activities on the products according to the defined uses in this notice.
\u2022 Partners: We may also share Personal Data with our business Partner e.g. other pharmaceutical companies who are our co-marketing, co-distribution, or other license partners, where obligations deriving from relevant medical information, pharmacovigilance or drug quality and safety for a product require such exchange of information.
\u2022 Service providers: When we use other companies to provide services on our behalf, e.g. technology, IT and cloud providers, professional advisors and support services such to operate a Kyowa Kirin global or regional medical information, pharmacovigilance or product complaint database.
\u2022 Business transfers: Personal Data collected from you in accordance with this Privacy Notice may also be transferred to a third party in the event of a sale, assignment, transfer, or acquisition of the company or a specific product or therapeutic area, in which case we would require the buyer, assignee or transferee to treat that personal data in accordance with applicable data protection laws.
We may disclose your personal information to public authorities, regulators or other third parties:
\u2022 We share information with national and\/or regional authorities, such as the European Medicines Agency in accordance with our obligations to to report certain pharmacovigilance and product relevant information to competent authorities; These reports will contain details about the incident but will only contain limited personal data and in particular:
– Patients: Information as provided, including date of birth\/age\/age group and gender (note that patient name will never be provided);
– Reporting Individuals: Information as provided, including name, profession, initials (to identify any duplications), address, email, phone number, to allow the regulatory authority to follow up with the reporting individual.
\u2022 To comply with any court order or legal obligation;
\u2022 When data is requested by our regulators, government agencies or law enforcement agencies or is required by any stock exchange rules;
\u2022 We may publish information about adverse events and\/or drug quality and safety (such as case studies and summaries); in this case, we will remove identifiers from any publications so that no individual can easily be recognized.<\/p>\n

8. International transfers<\/strong><\/span>
As part of our activities as above described we may need to transfer your data outside the UK, Switzerland and the EEA. For example, to meet our pharmacovigilance obligations that require us to review patterns across reports received from every country where we market our products, information provided as part of an adverse event report is shared within Kyowa Kirin on a worldwide basis through Kyowa Kirin\u2019s Global Database. This database is also the platform through which Kyowa Kirin uploads adverse event reports to various oversight authorities as required by law. The same applies for the appropriate and lawful handling of medical enquiries and product complaints.
This means that your personal data relating to medical information, pharmacovigilance or product complaints is transferred to Japan and countries outside the UK, Switzerland or the EEA, such as the United States, which may not provide a level of data protection equivalent to that provided in your country.
If we do this, your personal information will continue to be subject to an adeqdevme level of protection or appropriate standard contractual clauses and\/or other safeguards approved by the regulators. A copy of the relevant transfer mechanism can be provided for your review on request to the contact details above.<\/p>\n

9. Your data protection rights<\/strong><\/span>
You may be entitled under applicable law to ask Kyowa Kirin for a copy of your information, to correct it, erase or restrict its processing, or to ask us to transfer some of this information to other organisations. You may also have rights to object to some processing. These rights may be limited in some sitdevmions \u2013 for example, where we can demonstrate we have a legal requirement to process or keep your personal data. You may exercise these rights by contacting Kyowa Kirin, as above described . If we do not handle your request in a timely manner, or if you are not satisfied with our response to the exercise of these rights, you are entitled to submit a complaint with the competent supervisory authority of your country of residence or place of work. Further information and contact details of the European competent supervisory authorities can be found https:\/\/edpb.europa.eu\/about-edpb\/about-edpb\/members_en. UK residents may submit a complaint to the UK Information Commissioner\u2019s Office (ICO) here: https:\/\/ico.org.uk\/make-a-complaint\/. Swiss residents may contact Federal Data Protection and Information Commissioner (FDPIC) here: https:\/\/www.edoeb.admin.ch\/edoeb\/en\/home\/deredoeb\/kontakt.html.
Please note that for legal reasons, we cannot delete information that has been collected as part of an adverse event report unless it is inaccurate.
If you would like to exercise any of these rights, please contact us using the details set out in the \u2018Contact Information\u2019 section above. We may require you to provide proper identification before we comply with any request to access or correct Personal Data.
If you have unresolved concerns you also have the right to complain to the data protection authority in the country of your habitual residency.<\/p>\n

10. Security<\/strong><\/span>
Kyowa Kirin uses reasonable technical, administrative and physical safeguards to ensure appropriate security of personal data being collected and processed in relation to the management of medical information enquiries, pharmacovigilance reports and product complaints. Your data will be securely stored in information assets owned by or managed on behalf of Kyowa Kirin by third party service providers and may be hosted outside your home\/work jurisdiction. We will take necessary steps to ensure that adeqdevme safeguards are put in place.
Kyowa Kirin will maintain any information related to a medical enquiry, a pharmacovigilance report or a product complaint in the respective database, for as long as necessary (see above more specific retention periods) and to the extent permitted under applicable legal and regulatory requirements governing storage and reporting of related information for future historic reference, record keeping, auditing, regulatory and compliance purposes, as well as for the establishment, exercise or defense of legal claims.<\/p>\n

11. Changes to this Privacy Notice<\/strong><\/span>
We may change this Privacy notice from time to time in response to technical, legal or business developments.
If we decide to change the substance of this Privacy Notice materially, we will post those changes through a prominent notice on our corporate website.<\/p>\n

Effective: February 2024<\/p>\n

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Please read this Privacy Notice, together with any other privacy notice that we may provide to you, as it contains important information about how we collect, manage, use and protect your personal data. It also describes your data protection rights, including a right to object to some of the processing which we carry out. More information about your rights, and how to exercise them, is set out in the \u201cYour rights\u201d section below.<\/span>\u00a0<\/span><\/p>\n

This Privacy Notice may also be used in conjunction with other privacy notices that we may provide you with in certain sitdevmions.<\/span>\u00a0<\/span><\/p>\n

We may change this Privacy Notice from time to time. Please check this notice frequently to ensure you are aware of the most recent version and the date that it was last updated.<\/span>\u00a0<\/span><\/p>\n

This policy was last updated in March 2024.<\/span>\u00a0<\/span><\/p>\n

Who are we?<\/b>\u00a0<\/span><\/p>\n

Kyowa Kirin International plc is part of the Kyowa Kirin Group. The Group is made up of different legal entities, details of which can be found <\/span>here<\/span><\/b><\/a> and which may be updated from time to time. When we say \u2018KKI\u2019, \u2018we\u2019 or \u2018us\u2019 in this policy, we are referring to the relevant company in the Kyowa Kirin Group responsible for processing your personal data.<\/span>\u00a0<\/span><\/p>\n

KKI is a \u201cdata controller\u201d of the personal data that we hold about you. This means that we are responsible for deciding how we hold and use personal information about you. We are required under data protection legislation to notify you of the information contained in this privacy notice.<\/span>\u00a0<\/span><\/p>\n

What information do we collect?<\/b><\/span>\u00a0<\/span><\/p>\n

Personal data, or personal information, means any information about an individual from which that person can be identified. It does not include data where the identity has been removed (anonymous data).<\/span>\u00a0<\/span><\/p>\n

We may collect, use, store and transfer different kinds of personal data about you. What information we collect depends on your interactions with us, for example, if you are a patient then the information collected may vary from the information we collect from health care professionals.<\/span>\u00a0<\/span><\/p>\n

Please note that if you are a health care professional or a candidate for a job vacancy at KKI, dedicated Privacy Notices apply concurrently to the\u00a0 processing of your personal data.\u00a0<\/span>\u00a0<\/span><\/p>\n

We have grouped together the types of information that we may collect from you as follows:<\/span>\u00a0<\/span><\/p>\n

When you register for our newsletters or meetings or if you correspond with us:<\/span>\u00a0<\/span><\/p>\n