Privacy Notice Safety Information

Privacy Notice Safety Information

NOTICE OF PERSONAL DATA PROCESSING RELATED TO SAFETY INFORMATION

Pharmacosmos A/S is required by law to collect complaints and safety information concerning our products and whilst doing so to also protect your personal data. This Notice explains how we process (e.g. collect, use, store, and share) your personal data. We will process any personal data about you in accordance with this Notice and with applicable law. In Pharmacosmos we collect all safety information on our products into a database. We analyse the data on a regular basis to determine if there is any new information about our products that we need to share with authorities, doctors and patients. This is all done with the purpose of securing the safety of our products and patients.

Who are we?

The company responsible for processing your personal data is Pharmacosmos A/S: You can always contact Pharmacosmos or the Pharmacosmos Data Privacy Officer at dataprotection@pharmacosmos.com with questions or concerns about how we process your personal data.

How do we collect personal data about you?

We get your personal data from the following sources:

• From you directly
• From Health Care Professionals such as your nurse, a pharmacist or doctor
• From publicly available publications, websites, or social media

Why do we process your personal data?

We process personal data about you for the following purposes:

• To perform a scientific evaluation of any complaint or side effect potentially related to a Pharmacosmos medicinal product
• To file side effects in our global safety database, which is regularly analysed for overall patterns
• To assess patterns associated with complaints, including side effects

What personal data do we process about you?

For the purposes described above in Section 3, we may process the following types of personal data: • Contact information (name, address, telephone number, email address)

• Data revealing racial or ethnic origin
• Data concerning health and medicinal products you are using

Why are we allowed by law to process your personal data?

Our processing of your personal data requires a legal basis. By law, we are allowed to process your personal data described above in Section 4 based on the following legal bases:

• The processing is necessary for our compliance with the legal safety obligation

How do we share your personal data?

We may share your personal data with:

• Health authorities
• Other Pharmacosmos entities (e.g., Pharmacosmos affiliates in other countries)
• Partner companies that assist our company (e.g. licence partners, consultants, IT service providers)

When do we transfer your personal data outside the eu/eea?

For the purposes described above in Section 3, we transfer your personal data to the following countries outside the European Economic Area (EEA):

• All non-EEA countries in which Pharmacosmos have a physical presence We use the following safeguard, as required by law, to protect your personal data in case of such transfers:
• The transfer is to a Pharmacosmos entity covered by Standard Contractual Clauses.

How long will we keep your personal data?

We will keep your personal data for the following period of time:

• 12 years for data relating to technical complaints
• Permanently for data relating to side effects
• Up to 5 years for all other enquiries

What are your rights?

In general, you have the following rights:

• You can get an overview of what personal data we have about you
• You can get a copy of your personal data in a structured, commonly used and machine-readable format
• You can get an update or correction to your personal data
• You can submit a complaint about how we process your personal data to a Data Protection Authority. Under applicable law, there may be limits on these rights depending on the specific circumstances of the processing activity.

Contact us as described in Section 1 with questions or requests relating to these rights. Pharmacosmos A/S, Roervangsvej 30, DK-4300 Holbaek, Denmark.

Amendments

We may amend this Privacy Notice from time to time. If we make changes, we will notify you by revising the date at the top of the notice and, depending on the specific amendments; we may provide you with additional notice. We encourage you to review the Privacy Notice whenever you access our services to stay informed about our information practices and the ways you can help protect your privacy.

Privacy Notice of personal data processing related to safety information version 1: 2018-12-18