Actavis Privacy Notice for Pharmacovigilance, Medical Information and Product Complaints

“Actavis” means PT Actavis Indonesia having its principal office at Jalan Raya Bogor KM. 28, Jakarta 13710, Indonesia, including the Data Controller, who is the local affiliate in your country.

Actavis and your privacy

Ensuring patient safety is extremely important to Actavis and we take the safe use of all our products seriously. Actavis needs to be able to get in touch with people who contact Actavis about our products in order to follow-up and obtain further information, give answers to requests or to send requested material. This Privacy Notice describes how we collect and use Personal Data (which means information in any format that can be used, directly or indirectly, alone or in combination with any other information, to identify a person or as otherwise defined in applicable legislation) to help us fulfil our pharmacovigilance, product/quality complaint and medical inquiry obligations/requests to monitor and ensure the safety and quality of all our products, including medicines, cosmetic products, food supplements and medical devices that we market or have in clinical development.

Although this Privacy Notice is also applicable to cosmetic products, food supplements and medical devices, to facilitate the reading only reference to drug safety is made.

Scope of this Privacy Notice

This Privacy Notice applies to information we collect from or about you online (such as website, social media, chatbot or live chat, applications), by phone, fax, e-mail or post, as part of the adverse event, quality or medical inquiry or reporting regulations applicable to Actavis. We may also collect this information about you through specific forms submitted by you on a website that is owned or controlled by Actavis. An “adverse event” means an unwanted, unintended or harmful event in relation to the use of an Actavis product. With respect to medical devices, it also includes “incidents” and for cosmetics "serious undesirable effects", but for ease of reading, only the term “adverse event” will be used in this Privacy Notice. Pharmacovigilance legislation 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.

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. We may also receive your Personal Data from our license partners, competent authorities and research in the scientific and medical literature. However, such data is often pseudonymised and de-identified.

Information regarding data processing

For Europe, the UK and Switzerland: Transfers to Israel are based on the European Commission’s adequacy decision for the State of Israel. Transfers to India and to the USA are based on European Commission Model Clauses or equivalent based on applicable data protection laws.

For other countries: Transfers abroad (including to countries that provide a lower level of privacy protection) are based on a relevant mechanism to safeguard transfers, such as consent or appropriate agreements.

Information on the mechanism can be provided upon request to Actavis Data Protection Office (contact information below).

Purposes of Data Processing

All information is only processed where relevant and necessary to document your reaction properly and for the purpose of meeting our pharmacovigilance, safety, quality and any other legal requirements. The legal requirements exist to allow us and competent authorities (such as the European Medicines Agency and relevant local authorities) to evaluate adverse events, quality complaints or medical inquiries and make efforts to prevent similar events from happening in the future. We also need to process this information in order to respond to any request or inquiry made by you (follow up). Your data will not be used for any other purposes than those purposes listed herein.

Data Retention

Any Personal Data which is collected for any of the above purposes will be retained in pseudonymised form (when possible and only after any necessary follow up), in a fully secured manner, and minimized in accordance with data protection principles. Because patient and product safety is so important, we retain the information we gather about adverse events, quality complaints or medical inquiries to ensure that we can properly assess the safety and suitability of our products over time. As we operate as a global company, in order to meet international legal requirements, this data is retained for a period 30 years following life of the product market authorisation. Afterwards, Personal Data is deleted, anonymised, or otherwise irreversibly destroyed in accordance with procedures. 

How we use and share Personal Data

We may use and share Personal Data to:

• investigate the adverse event, quality complaint or medical inquiry;
• contact you for further information about the adverse event, quality complaint or medical inquiry you reported;
• collate the information about the adverse event, quality complaint or medical inquiry with information about other adverse events, quality complaint or medical inquiries received by Actavis to analyse the safety of a batch, Actavis product or active ingredient as a whole (only in pseudonymised form); and
• provide mandatory reports to national and/or regional authorities so that they can analyse the safety of a batch, Actavis product, active ingredient as a whole alongside reports from other sources (in pseudonymised form where possible).

Our pharmacovigilance and quality 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 or quality report is shared within Actavis on a worldwide basis through Actavis’s global database. This database is also the platform through which Actavis 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. We also maintain a global medical inquiry database in order to answer your inquiries and internally manage these answers. However, your Personal Data is pseundonymised and de-identified when possible in order to protect your privacy.

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.

Further Information regarding Pharmacovigilance

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 may also share Personal Data with our service providers, who process them on our behalf. They are provided with the information on a need-to-know basis and are not authorized to use or disclose Personal Data for their own marketing or other purposes.

Additionally, in some cases, as part of our market authorisation for a particular product, you may be enrolled in a patient safety programme, in which case further information on data processing (such as any additional data sharing or transfers) would be provided to you at the time of your enrolment.

We share information with national and/or regional authorities, such as the European Medicines Agency and other similar local authority in accordance with pharmacovigilance laws. We are unable to control their use of any information we share, however note that in these circumstances, we do not share any information that directly identifies any individual (such as names or contact information), but we only share pseudonymised information. We may publish information about adverse events (such as case studies and summaries); in this case, we will remove identifiers from any publications so that no individual can easily be recognized.

Your rights

You may be entitled under applicable law to ask Actavis for a copy of your information, to correct it, erase or restrict its processing, or withdraw your consent to 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 or keep your Personal Data. Once we have erased your information upon your request, it will no longer be available within Actavis systems, so you will not be able to obtain it from Actavis again. You may exercise these rights by contacting Actavis’s Data Protection Office (contact information below). 

Please note that we may require you to provide proper identification before we comply with any request to access or correct Personal Data.

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 Actavis’s Data Protection Office (see below for contact information).Harap dicatat bahwa kami mungkin meminta Anda untuk memberikan identifikasi yang tepat sebelum kami memenuhi permintaan apa pun untuk mengakses atau mengoreksi Data Pribadi.

Security

Actavis takes reasonable measures to secure Personal Data under applicable privacy laws 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.

Changes to this Privacy Notice

If we decide to change the substance of this Privacy Notice materially, we will post those changes through a prominent notice.

Contact Information

If you have any concerns about how we process your Personal Data or wish to exercise any of your rights or wish to obtain other information, such as a copy of a legitimate interests balancing test, you can get in touch with our Actavis Data Protection Office by contacting us:

For Europe, UK and Switzerland, you can contact our Data Protection Officer at EUPrivacy@tevaeu.com.
For the United States, you can contact us at USPrivacy@tevapharm.com.
For other regions, please contact us at IMPrivacy@tevapharm.com.

We hope that we can satisfy any queries you may have about the way in which we process your Personal Data. However, if you have unresolved concerns you may also have the right to complain to the data protection authority in the location in which you live, work or believe a data protection breach has occurred.