Privacy statement on Pharmacovigilance

Macure Pharma ApS and its affiliates (hereinafter “Macure”) is a specialty pharmaceutical company focused on niche pharmaceuticals. The safety of Macure products has to be monitored. These monitoring activities are referred to as pharmacovigilance and this statement provides information on how we process Personal Data for Pharmacovigilance purposes.

We may need to process personal data about the Patient and/or the Reporter. Patient data may include patient name, initials, age, gender, weight and height. There may also be information about patient health, medical history, medical status, and racial or ethnic origin. Reporter data may include name, contact details and profession.

Personal Data for pharmacovigilance cases are processed exclusively for this purpose and only where relevant in order to fulfil Macure’s pharmacovigilance obligations. When processing data, it is possible to exchange data within Macure and competent regulatory authorities. Third party service providers may also be included in data exchange. When exchanging personal data with third party service providers we have appropriate data protection safeguards in place. Contracts containing EU Standard Contractual Clauses according to EU Commission decisions of 27 December 2004 (2004/915/EC) and 05 February 2010 (C(2010) 593) constitute appropriate and suitable safeguards to ensure compliance with GDPR.

Data may also be exchanged with business partners where pharmacovigilance obligations for Macure require exchange of personal data for pharmacovigilance purposes. When exchanging personal data with business partners we have appropriate data protection safeguards in place. Contracts containing EU Standard Contractual Clauses according to EU Commission decisions of 27 December 2004 (2004/915/EC) and 05 February 2010 (C(2010) 593) constitute appropriate and suitable safeguards to ensure compliance with GDPR.

When information on pharmacovigilance is published by Macure, we make sure to remove identifiers to keep personal identity private.

Personal data kept for pharmacovigilance purposes are kept secure by technical and organisational measures. These measures ensure, that personal data is only available to employees, who need it to perform their job responsibilities. Personal data is stored in accordance with mandatory legal requirements. This includes storage of pharmacovigilance data for at least ten years after withdrawal of the related Macure product.

If Macure is storing your personal data, you have certain rights:

• Request information on your personal data
• Request correction of your personal data if incorrect or incomplete
• Request transfer of your personal data to you or another person
• File a complaint with the data protection authority
• Object to processing of your personal data when the processing is only based on Macure’s legitimate interest
• Request deletion of your personal data if they are no longer necessary for the purpose of processing

Please note, that some pharmacovigilance responsibilities may be limited in order to fulfil Macure’s pharmacovigilance obligations.

If you have any questions on data privacy, please contact info@macurepharma.com.