Pharmacovigilance, Medical Information and Product Quality Privacy Notice
Individuals who raise a medical information inquiry, product quality complaint or are involved in drug safety monitoring activities.
This Privacy Notice (“Notice”) for Pharmacovigilance, Medical Information & Product Quality, describes how we process personal data (i.e., any information relating to an identified or identifiable natural person) to monitor drug safety (“pharmacovigilance”), handle medical information inquiries and manage product quality complaints. It also provides you with information about your rights under data protection laws. Your personal data will be processed according to applicable legislation, including the EU or UK General Data Protection Regulation (“GDPR”) and other local laws applicable to the processing of personal data. You should read this Notice and any other Notices that we provide to you.
The controller of your personal data is the Otsuka company that handles your inquiry (“Otsuka”, “we” or “us”). In addition, any other Otsuka company that processes personal data might become a controller or joint controller of such data. To exercise your rights or to ask questions, please contact the Otsuka company in your country. A list of all Otsuka companies and their contact details can be found under “How to contact us?”.
We may process personal data about you from a variety of sources. As a rule, we collect and process personal data that you disclose to us or (if necessary for case handling) to other Otsuka companies (e.g. documents you provide or forms that you fill out). We also collect and process personal data from third party sources, including publicly available sources (e.g if it is relevant for our pharmacovigilance activities and we are legally obliged to collect this personal data). Otsuka collects and uses some or all of the following categories of personal data for the purpose(s) described below:
- Pharmacovigilance: We collect the name, contact information, and professional details of the reporting individual. We may collect some additional personal data related to health and medical history of the individual experiencing an adverse event if required for processing of adverse event for pharmacovigilance purposes. Where the individual experiencing an adverse event is different to the individual reporting the adverse event, additional personal data may need to be collected including year of birth, age, gender and other such details that may support Otsuka in identifying the individual experiencing the adverse event.
- Medical Information Requests: We may collect the name, contact information and professional details of the individual making the request.
- Product Quality Complaints: We may collect the name, contact information and professional details of the individual reporting the complaint.
- Call Recording and Monitoring: We may record and/or monitor our calls with you where you have provided your consent for us to do so. Where call recording and/or monitoring occurs, we may process the data listed above under Pharmacovigilance, Medical Information Requests and/or Product Quality Complaints, and the phone number of the caller.
In the event that medical information requests or product quality complaints contain information on adverse events, the data described under the Pharmacovigilance bullet point may be processed.
We process the personal data listed above for the following purposes and legal bases, which may vary depending on where you live and where we operate:
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Purpose |
Legal basis |
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Pharmacovigilance In the area of pharmacovigilance, we process data for the following purposes: to investigate the adverse event, to contact you to obtain further information about the adverse event you have reported and to document possible pharmacovigilance in registries. |
The processing of personal data is necessary for reasons of public interest in the area of public health, specifically ensuring high standards of quality and safety of health care and of medicinal products or medical devices. It is also necessary for compliance with a legal obligation in the context of pharmacovigilance legislation. Art. 6 (1) c) and e) GDPR and Art. 9 (2) i) GDPR in connection with pharmacovigilance legislation and local data protection laws. |
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Medical Information In the area of medical information, we process data for the following purposes: Evaluation, classification and assessment of medical information requests, to follow up on such requests and maintain the information in a medical information database for reference. |
It is in our legitimate interest to process your personal data in order to respond to your inquiry and to comply with documentation and record-keeping obligations. The processing of personal data is also necessary for reasons of public interest in the area of public health, specifically ensuring high standards of quality and safety of health care and of medicinal products or medical devices. Art. 6 (1) f) GDPR and Art. 9 (2) i) GDPR. |
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Product Quality Complaints In the area of product quality complaints, we process data for the following purposes: |
It is in our legitimate interest to process your personal data in order to respond to your complaint, to request and manage a sample if necessary, and to fulfil documentation and recording obligations, as well as to forward the information provided to the responsible manufacturer if necessary. The processing of personal data is also necessary for reasons of public interest in the area of public health, specifically ensuring high standards of quality and safety of health care and of medicinal products or medical devices. Art. 6 (1) f) GDPR and Art. 9 (2) i) GDPR. |
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Call Recording and Monitoring |
This processing is conditional on you having provided your prior consent (Art. 6 (1) a) GDPR). |
We disclose your personal data to the following categories of recipients:
- to our group companies to process safety information, medical information inquiries or product quality complaints.
- to third party services providers who provide data processing services to us, or who otherwise process personal information for purposes that are described in this Notice, especially for the purpose of outsourcing specific business activities and to request external support and resources: IT services (infrastructure, system management and maintenance, system security and improvement, development, testing and technical support), databases (for the documentation of adverse events or inquiries in the area of medical information or product quality complaints), Service providers that support the processing of adverse events, medical inquiries or complaints on behalf of Otsuka such as call centre providers or providers that support the handling of individual cases.
- to any competent law enforcement body, regulatory, trade association, government agency, court or other third parties where we believe disclosure is necessary (i) as a matter of applicable law or regulation, (ii) to exercise, establish or defend our legal rights (on the basis of our interest in the defence of our rights), or (iii) to protect your vital interests or those of any other person;
- Business successor in the event of the sale, assignment or transfer of a specific Otsuka product or related project.
- to any other person with your consent to the disclosure.
These recipients of your personal data may be acting on our behalf, as joint controllers or as data controllers in their own right.
We use appropriate technical and organisational measures to protect the personal data that we collect and process about you. The measures we use are designed to provide a level of security appropriate to the categories of personal data processed.
We may transfer your personal data to other Otsuka group companies, service providers and partners located outside of the United Kingdom or the European Economic Area (“EEA”) (as appropriate), for example in the USA or Japan. Please note that countries outside of the United Kingdom or the EEA may not provide the same level of protection for your personal data. Where we transfer your personal data outside of the United Kingdom or the EEA, we ensure that appropriate safeguards are put in place and that all transfers of your personal data comply with applicable data protection laws.
The appropriate safeguards that Otsuka uses are based on the model clauses approved by the Information Commissioner’s Office and the European Commission. To find out more about how we safeguard your information in relation to data transfers outside the United Kingdom or the EEA, please contact us using the details in the ‘How to contact us?’ section below.
Pharmacovigilance: We process personal data in accordance with the legal requirements for the storage and reporting of adverse events information. We are obliged to retain such information until the respective medical product has been withdrawn from the market and for at least 10 years thereafter.
Medical information: After we have responded to your request, we will retain information about the request for as long as necessary for documentation purposes and legal obligations by local law. The request will then be anonymized where this is consistent with local data protection regulations. Medical inquiries containing adverse event information will be handled in accordance with pharmacovigilance requirements.
Product quality complaints: After we have responded to your complaint, we will retain information about it for documentation purposes and regulatory obligations for as long as required by local law. Product complaints containing adverse event information will be handled in accordance with pharmacovigilance requirements.
You have several rights, which apply to our use of your personal data. The availability of these rights depends upon our lawful basis for processing your personal data and your rights may also be subject to certain conditions and restrictions. These rights are:
- Right to information
- Right of access
- Right to rectification
- Right to erasure (also ‘right to be forgotten’)
- Right to restriction of data processing
- Right to data portability
- Right to object
For more information on the rights that you have, please click here or go to https://privacy.otsuka.co.uk/data-subject-rights.
Under the GDPR, you also have the right to complain to a data protection authority about our collection and use of personal data. For more information, please contact your local data protection authority. A list of data protection authorities in the European Economic Area is available
Should you have any questions in regards to the protection of your personal data, the respective roles and relationships of the joint controllers towards you or if you wish to exercise your legal rights, please submit your query to the Otsuka company that handles your inquiry.
| Otsuka company | Address | Contact details of Otsuka company and its data protection officer (if applicable) |
| Otsuka Pharmaceutical Europe Ltd. | 2 Windsor Dials, Arthur Road, Windsor, Berkshire, SL4 1RS, UK | privacy@otsuka-europe.com |
| Otsuka Pharmaceuticals UK Ltd. | 2 Windsor Dials, Arthur Road, Windsor, Berkshire, SL4 1RS, UK | privacy@otsuka.co.uk |
| Otsuka Pharma Scandinavia AB | Sveavägen 151, 113 46 Stockholm, Sweden | privacy@otsuka.se |
| Otsuka Pharmaceutical, S.A.1 | Avenida Diagonal, 615 9º planta, Barcelona 08028, Spain | privacy@otsuka.es |
| Otsuka Pharma GmbH | Europa-Allee 52, 60427 Frankfurt am Main, Germany | privacy@otsuka.de |
| Otsuka Pharmaceutical France SAS | L’Atria – 6ème étage, 1-15 avenue Edouard Belin, CS 40066, 92566 Rueil Malmaison, Cedex, France | privacy@otsuka.fr |
| Otsuka Pharmaceutical Italy S.r.l. | Via Fabio Filzi 29, 20124 Milan, Italy | privacy@otsuka.it |
| Otsuka Pharmaceutical (Switzerland) GmbH | Sägereistrasse 20, CH-8152 Glattbrugg, Switzerland | privacy@otsuka.ch |
| Otsuka Pharmaceutical Netherlands B.V. | Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands | privacy@otsuka-europe.com |
1 Otsuka Pharmaceutical, S.A. is in compliance with the Code of Conduct regulating the processing of personal data within the scope of Clinical Trials and other Clinical Research and Pharmacovigilance, sponsored by Farmaindustria and approved by the Spanish Data Protection Agency (AEPD).
Please, be advised that you may file a complaint with the Code of Conduct Governance Body at secretariacodigo@farmaindustria.es.
In the event that the reporter is not a healthcare professional, it is necessary to request that the contact details of the patient’s healthcare professional who has the information regarding the adverse reaction be provided.
Last Updated: June 2025