“Adverse event” means an unwanted, unintended or harmful event in relation to the use of a Teva medicinal product.
“Affiliate(s)” shall mean any person, corporation, company, partnership, joint venture or other entity controlling, controlled by or under common control with Teva. For such purpose the term “control” means the holding of 50% or more of the common voting stock or ordinary shares in, or the right to appoint 50% or more of the directors of the said corporation, company, partnership, joint venture or entity.
“Personal Data” means information in any format that can be used, directly or indirectly, alone or in combination with any other information, to identify a person.
“The policy is also applicable to cosmetic products since the [local] regulation on cosmetic is requiring similar safety monitoring. However to facilitate the reading only reference to pharmacovigilance is made.”
If you are a patient we may also be provided with information about you by a third party reporting an adverse event that affected you. Such third parties may include medical professionals, lawyers, relatives or other members of the public.
Teva is under legal obligations to collect specific data. This is specified in more detail below.
Patients (subject of report)
We collect personal data about you when you or a third party provides us with information in relation to an adverse event that affected you or someone else. Where you are reporting the adverse event yourself, please also refer to the Reporters section.
Pharmacovigilance laws require us to take “detailed records” of every adverse event passed to us to allow the event to be evaluated and collated with other adverse events recorded about that product. The personal data that we may collect about you when you are the subject of an adverse event report is:
Some of this information is considered by law to be “sensitive personal data” about you. This includes any information that tells us about your:
This information is only processed where relevant and necessary to document your reaction properly and for the purpose of meeting our pharmacovigilance and/or legal requirements. These requirements exist to allow us and competent pharmacovigilance authorities (such as the European Medicines Agency and other authorities) to manage adverse events and make efforts to prevent similar events from happening in the future.
We collect information about you when you provide us with information in relation to an adverse event you report.
Pharmacovigilance laws require us to ensure that adverse events are traceable and available for follow-up. As a result, we must keep sufficient information about reporters to allow us to contact you once we have received the report. The personal data that we may collect about you when you report an adverse event is your:
Where you are also the subject of a report, this information may be combined with the information you provide in relation to your reaction.
As part of meeting our pharmacovigilance obligations, we may use and share Personal Data to:
We may also share Personal Data with other pharmaceutical companies who are our co-marketing, co-distribution, or other license partners, where pharmacovigilance obligations for a product require such exchange of safety information.
We share information with national and/or regional authorities in accordance with pharmacovigilance laws. We are unable to control their use of any information we share.
We may publish information about adverse events (such as case studies and summaries); we will remove identifiers from any publications so that no individual can easily be recognized.
Our pharmacovigilance obligations require us to review patterns across reports received from every country where we market our products. To meet these requirements, information provided as part of an adverse event report is shared within Teva on a worldwide basis through Teva’s Global Database. This database is also the platform through which Teva uploads adverse event reports to various oversight authorities, including the Eudravigilance database (European Medicines Agency corporate system for managing and analysing information on suspected adverse reactions to medicines which have been authorised in the European Economic Area ) and other similar databases as required by law.
Because patient safety is so important, we retain all the information we gather about you as a result of an adverse event report to ensure that we can properly assess the safety of our products over time.
You may be entitled under applicable law to ask Teva 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 situations – for example, where we can demonstrate we have a legal requirement to process your personal data. You may exercise these rights by contacting Teva’s Pharmacovigilance team at PhV@tevacanada.com . For legal reasons, we cannot delete information that has been collected as part of an adverse event report unless it is inaccurate. We may require you to provide proper identification before we comply with any request to access or correct Personal Data. Your right to access or correction may be limited by applicable law. We hope that we can satisfy any queries you may have about the way in which we process your personal data. If you have any concerns about how we process your personal data, you can get in touch with Teva’s Pharmacovigilance team at [e-mail]. However, if you have unresolved concerns you also have the right to complain to the data protection authority in the location in which you are based.
Teva takes measures to secure Personal Data from accidental loss and from unauthorised access, use, alteration or disclosure. Additionally, we take further information security measures including access controls, stringent physical security and robust information collection, storage & processing practices.
All pharmacovigilance databases, including the Global Database, are hosted in Israel by Teva. These are administered and supported around the clock by Teva’s dedicated pharmacovigilance IT teams in Israel, Germany and the United States. Teva also engages a data processing company in India for data entry, administration and data cleansing of a limited part of the pharmacovigilance database.
Personal Data is submitted to Teva and is hosted and stored in databases on servers situated in Israel, which are owned and maintained by Teva Pharmaceutical Industries Ltd., an Israeli limited liability company whose principal place of business is at:
5 Basel Street
PO Box 3190
Petach Tikva 49131