PRIVACY STATEMENT FOR PHARMACOVIGILANCE ACTIVITIES
Effective Date: November 4, 2022
1. What is Pharmacovigilance and What is Lupin’s obligation?
Pharmacovigilance is defined by the World Health Organization (WHO) as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem”.
Pharmaceutical companies have a responsibility of reporting and analysing adverse drug experiences associated with respect to their marketed products to regulatory authorities worldwide per the country specific reporting obligations for continuous benefit risk assessment of the products. To comply with the requirement, Lupin has set-up a system for consumers or health care providers to report any adverse event associated with Lupin products. For contact information please visit our website https://www.lupin.com/US/contact-us/
2. What does this Statement cover?
This PV Privacy Statement (“Statement”) describes how the American affiliates of Lupin Limited/India which act as Marketing Authorization Holders and/or Distributors for medical products ("Lupin" we", "us" or "our") collect, use and share your personal information for activities that are related to pharmacovigilance. The scope of this statement is strictly limited to how we collect, use and share your personal information collected for pharmacovigilance.
Please see our Lupin Privacy Notice at for general information about how we collect, use and share personal information.
For California consumers, you may have additional rights regarding the use of your personal information. Please see Your California Privacy Rights for more information about those rights and how you can exercise those rights.
Lupin Limited has designated Lupin Pharmaceuticals Inc, Lupin Inc. and Novel Labs Inc. as its representative for Pharmacovigilance in the USA.
3. What personal information we collect from You
For our pharmacovigilance obligations, Lupin may collect, use and share the following categories of personal information about you:
• Contact information, such as your name, phone number, email address and home address
• Other personal details, such as your date of birth, age, gender, weight, height, marital status or relationship to a person and picture
• Records of customer service calls
• Job title and professional qualifications;
• Health information (physical or mental), such as medical history including medical diagnostic results and medication received, accident and injury reports, disability status genetic information or health risk factors
• Racial or ethnic origin
We collect this information from you directly when you contact us via letter, fax, telephone, email and in person or from a health care provider, relative or other third person in relation to your care.
For example, data is collected through forms that you complete; from correspondence with you; or through meetings, calls or other communications that may take place.
4. Why we collect, use and share your personal information
We collect, use and share your personal information for the reasons set out below:
• With your consent:
- Where you have provided us with your express consent to process your personal information for a particular purpose
• For operation of our business and communications with you:
- To respond to requests for medical information or product information
- For reporting, assessing and processing of adverse events
- For the elaboration of studies, market research on our products and product developments, in which case the data will be pseudonymized to prevent your identification
- Determination of suitability for certain products, services or programs
- To improve our products
- To administer our contracts with service providers
• Where necessary to comply with legal obligations such as:
- Monitor and report on product safety and quality
- Administration and legal maintenance of product registries (where required under applicable laws)
- Management of adverse events, including investigating the adverse event and contacting you for further information on the adverse event that you have reported or was reported on your behalf
- Provision of reports to authorities with respect to the safety of a Lupin product
- Responding to court orders, subpoenas or other legal processes with which Lupin is required to comply
- Complying with legal, regulatory and other requirements under applicable U.S. federal and state laws
5. With whom do we share your personal information and why?
We may share pseudonymized personal information with government agencies, service providers and / or law enforcement officials if required for the purposes above.
Pseudonymization is a method that allows companies to switch the original data set (for example, e-mail or a name) with an alias or pseudonym. It is a reversible process that de-identifies data but allows the re-identification later if necessary.
We have offices and operations in several international locations, and we share information between our group companies for business and administrative purposes. Your information may be shared with our internal staff for pharmacovigilance and administrative purposes, located outside of the USA, as outlined above. Please visit https://www.lupin.com/contact-us/global-offices/ to see a list of the locations within our corporate group. For this purpose, your personal information will be pseudonymized.
In addition, Lupin may also share your personal information with the following third-party recipients:
National and/or international regulatory, enforcements, public body or courts where we are required to do so by applicable law or regulation or at their request.
To comply with the applicable laws or regulation and react at their request.
Co-marketing and distribution partners (Marketing Authorization Holder of the product or connected Marketing Authorization Holder) including third party auditors
As per our pharmacovigilance agreements with co-marketing and distribution partners to allow them to comply with the applicable laws or regulations and respond to their requests.
Food & Drug Administration or other competent health authorities
To comply with the applicable pharmacovigilance laws.
Third-party buyers or assignees
To facilitate the sale and assignment of Lupin, where applicable.
We may share personal information with service providers pursuant to written agreements which require those service providers to treat such personal information in a confidential manner and to only use it for the purpose of providing the services to us. These may include but are not limited to medical service information providers and IT service providers, such as hosting and/or cloud providers.
6. How long we retain your personal information
Lupin will retain personal information relating to you in accordance with our customary pharmacovigilance retention periods and applicable legal reporting time periods.
Pharmacovigilance personal information will generally be kept for as long as is reasonably necessary taking into consideration our need to answer queries or resolve problems, any other purpose outlined above or to comply with legal requirements under applicable law(s), in particular by the US Food & Drug Administration regulations related to reporting of adverse events related to our products.
7. Updates to this Statement
We reserve the right to update this Statement at any time, and we will provide prominent notice on our website if we update this Statement when we make any substantial updates.
We may also notify you in other ways from time to time about the processing of your personal information.
8. Contact Us
If you have questions about this Statement or wish to contact us for any reason in relation to our collection, use or sharing of personal information, please contact us at:
• For Lupin Pharmaceuticals Inc, Lupin Inc. products: +1-800-399-2561
• For Lupin Somerset / Novel Labs Inc. products: +1-866-403-7592
• For Solosec: 1-844-765-6732
Customer Service Team:
Phone: +1 866-587-4617
Fax: +1 866-587-4627
Email: email@example.com (for US marketed products only)