PRIVACY STATEMENT FOR PHARMACOVIGILANCE ACTIVITIES

Effective Date: October 16, 2026

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 for reporting and analyzing adverse drug reactions associated with their marketed products to regulatory authorities worldwide per the country-specific reporting obligations for continuous benefit-risk assessment of the products. To comply with these requirements, Lupin has set up a system for patients, health care providers, and other individuals to report an adverse event associated with Lupin products. For contact information, please see Section 9 below.
   
   

2. What does this Statement cover?
   
   This Pharmacovigilance Privacy Statement (“Statement”) describes how the Canadian affiliate of Lupin Limited/India, which acts as Marketing Authorization Holder and/or Distributor for medical products (“Lupin”, “we”, “us”, or “our”), collects, uses, and discloses your personal information for activities that are related to pharmacovigilance, as appropriate and required by applicable regulation. The scope of this Statement relates only to how we collect, use, and disclose your personal information collected for our pharmacovigilance program and to protect patient safety.
   
   Please see our Lupin Privacy Statement for general information about how we process personal information.
   
   Lupin Limited has designated Lupin Pharma Canada Ltd. as its representative for pharmacovigilance in Canada.
   
   

3. What personal information do we collect from you?
   
   To meet our pharmacovigilance obligations, Lupin may collect, use and disclose 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
   • Records of customer service calls
   • Job title and professional qualifications
   • Health information (physical or mental), such as medical history including medical diagnostic results, laboratory test reports or relevant laboratory data, 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, telephone, email, and in person, or from a health care provider, relative or any other third person in relation to your care.
   
   For example, we collect personal information through forms that you complete, from correspondence with you, or through meetings, calls or other communications that may take place.
   
   

4. Why do we collect and use your personal information?
   
   We collect and use 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 determine 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:
     • Monitoring and reporting 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 Canadian federal and provincial laws
   
   

5. To whom do we disclose your personal information and why?
   
   We may disclose identifiable or pseudonymized personal information for the purposes described above.
   
   Pseudonymization is a method that allows companies to switch the original data set (for example, email or a name) with an alias or pseudonym. It is a reversible process that deidentifies data but allows re-identification later if necessary. We disclose pseudonymized personal information to government agencies for pharmacovigilance purposes.
   
   We have offices and operations in several international locations, and we may disclose your personal information to our group companies, service providers, and business partners as part of our pharmacovigilance activities and for business and administrative purposes. Your information may be shared with our internal staff located outside of Canada for pharmacovigilance and administrative purposes, as outlined above. Please visit https://www.lupin.com/about-us/global-presence to see a list of the locations within our corporate group.
   
   Specifically, Lupin may disclose your personal information in an identifiable or pseudonymized format to the following third-party recipients:
   
   

6. What are your rights regarding your personal information?
   
   Under Canadian federal or provincial laws, you may have the right to access and correct your personal information. We will take reasonable steps to verify your identity before granting access or making corrections. These rights may be limited if they interfere with our pharmacovigilance obligations or our ability to comply with other legal requirements. In order to exercise any of your rights, please contact us using the contact details provided in Section 9 below.
   
   

7. How long do 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 respond to inquiries during audits and inspections, meet our contractual obligations, comply with our legal requirements under applicable law(s), in particular the Canadian Food and Drug Regulations related to reporting of adverse events related to our products, and fulfill other purposes as outlined in this Statement.
   
   

8. Updates to this Statement
   
   We reserve the right to update this Statement at any time. and we will provide prominent notice on our website when we make any substantial updates to this Statement. We may also notify you in other ways from time to time about the processing of your personal information.
   
   

9. Contact Us
   
   If you have questions about this Statement or wish to contact us for any reason in relation to our collection, use or disclosure of personal information, please contact us at:
   
   Phone: +1 844-587-4623
   Email: dsrm@lupin.com