Information for patients, consumers, HCPs, and third parties, concerning processing of your personal data in the context of reporting adverse events and filing quality complaints

  The company MINERVA PHARMACEUTICAL S.A. (hereinafter the “Company”) collects, records and processes certain personal data declared to the Company by patients, consumers, health care professionals and third parties, in the context of reporting adverse effects and filing quality complaints.

 The purpose of this information is to inform the above persons of the processing of their personal data by the Company for the management of adverse effect reports and quality complaints concerning medicines, cosmetics and other preparations manufactured and/or placed on the Greek market by the Company.

 

1. What categories of personal data do we collect and record on our files?;

The categories of personal data we collect about the users of our preparations (patients and consumers), who develop an adverse effect or are faced with a problem concerning the quality of our preparations (irrespective of whether this adverse effect is reported by them or whether the report is made by health care professionals) are those required by the legislation on medicines and the relevant regulatory framework; they mostly are as follows:

 (α) initials or code number of patient, sex, date of birth or age group, sex, age);

(β) information about medication or use of the Company’s preparations;

(γ) description of an adverse event and/or quality issue of the preparation and its outcome; and

(δ) in case of an adverse effect, the relevant medical history of the patient.

 

Notwithstanding the above, the Company may record the full name of a patient/consumer and other identification details (for example, contact details) only when deemed necessary for the completion of the monitoring of the course of patient/consumer and in general of the case (follow-up).

The categories of personal data collected and recorded by the Company about health care professionals (doctors, pharmacists, etc) that declare an adverse effect or file a quality complaint is the full name, the capacity and their contact details (telephone and/or email).

 

2. What are the purposes and legal bases for processing?

We collect, process and store the personal data of users (patients and consumers) of the Company’s preparations and of health care professionals that declare an adverse effect or a quality complaint for the purpose of our compliance with legislation on medicines and the relevant regulatory framework concerning pharmacovigilance and quality assurance of medicines, cosmetics and other preparations that the Company manufactures and/or places on the Greek market.

The legal bases for processing of the above personal data is our compliance with obligations arising from legislative and regulatory framework concerning medicines, cosmetics and other similar preparations, as well as ensuring high standards of quality and safety on our medicines and other products.

 

3.  Who are the personal data disclosed to?

In principle, your personal data are not disclosed to third parties. As an exception, your data may be disclosed to third parties (such as, for example, providers of pharmacovigilance services) that help us to record and assess reports of adverse effects and provide us with services; such parties undertake to process your personal data solely on account of and based on our recorded orders and not for their own benefit.

Moreover, as required by relevant legislation, we disclose anonymous or anonymised details concerning the adverse effect to the competent authorities (for example the National and European Organisation for Medicines and the European database Eudravigilance), as well before foreign Marketing Authorisation Holders, for whom we have exclusive distribution rights in the Greek market.

 

4. How do we process the personal data and how long is it kept for?

We take every measure necessary so as to safeguard security, integrity and confidentiality of personal data.

Typically, physical and electronic files of adverse effect reports and quality complaints are kept for a period of six (6) months from initial entry. By way of exception, identification details of patients/consumers (e.g. full name and contact details) are kept only for such period as required for the follow-up of the consumer/patient and the completion of the case and the taking of all necessary details for the exact recording of the adverse effect and/or quality complaint.

 

5. Your rights

Any patient, consumer, healthcare professional and third party filing an adverse effect report or quality complaint may request from the Company access, rectification and, in certain cases, erasure of their personal data. Such persons also have the right to restriction of processing of their personal data. These rights may be exercised by sending a relevant letter or an email to the Company’s Data Protection Officer to the address stated below.

Furthermore, the legislation grants the above persons the right to bring actions before the Personal Data Protection Authority.

 

6. Contact details of Data Protection Officer

For any question or query or in case you wish to exercise any of the rights provided for by the legislation, you may contact the Company’s Data Protection Officer as follows:

-Postal address:

MINERVA PHARMACEUTICAL S.A.

132 Kifissou Avenue

Peristeri 12131

-Telephone:

2105702199

-Email address:

personaldata@minervapharm.gr