PRIVACY STATEMENT FOR PHARMACOVIGILANCE ACTIVITIES (PV PRIVACY STATEMENT)
Effective Date: 3 November 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 reactions 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 these requirements, 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 http://www.lupinpharma.ca/contact-us
2- What does this Statement cover?
This PV Privacy Statement (“Statement”) describes how the Canadian affiliate of Lupin Limited/India which acts 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 relates only to how we collect, use and share your personal information collected for our pharmacovigilance program and to protect patient safety.
Lupin Limited has designated Lupin Pharma Canada Ltd. as its representative for pharmacovigilance in Canada.
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, 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 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
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 Canadian federal and provincial 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 a number of 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 Canada, 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:
6- Your rights
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 below.
7- 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 Canadian Food and Drug regulations related to reporting of adverse events related to our products.
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 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.
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 sharing of personal information, please contact us at:
Please call on: +1 844-587-4623
Email: drugsafety@lupin.com