SPONTANEOUS REPORTING - INFORMATION NOTICE
In accordance with Articles 13 and 14 of the Regulation (EU) 2016/679 of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data and on the free movement of such data ("GDPR")
Pursuant to Articles 13 and 14 of the GDPR, Chiesi Farmaceutici S.p.A. ("Chiesi"), as drugs marketing authorization holder, wishes to provide you with detailed information on how it will process personal data which may be collected in case of spontaneous reporting with reference to any adverse reaction that is suspected to have occurred after taking the drug. Therefore, we kindly ask you to carefully read the following information notice.
1) SOURCE OF PERSONAL DATA AND PURPOSES FOR THE PROCESSING
The personal data you have provided on an optional basis will be collected and processed exclusively to fulfill the legal obligations related to pharmacovigilance and, more specifically, for the purposes of the identification of any unknown adverse reactions, improvement and enhancement of the information on already known adverse reactions, assessment of the causal link between the administration of the medicine and the adverse reaction that was observed, as well as communication of the information to the competent authorities to ensure that the medicines used have a benefit/risk ratio that is beneficial to the population.
The data collected will involve:
a) as to the subject reporting the event: name, surname, contact details;
b) as to the subject to whom the report refers, at least one of the following categories of data: initials, age, gender. Special categories of data concerning health status may also be collected if part of the report.
The provision of the data is optional, but failure to provide the data under a) could compromise the proper management of your report, while failure to provide the data under b) will prevent Chiesi from fulfilling the legal obligations related to pharmacovigilance.
2) PROCEDURES FOR THE PROCESSING
The personal data you have provided or otherwise acquired by us within our activity may be processed in hardcopy, by automated or electronic means in compliance with the applicable laws and regulations, with procedures strictly related to the purposes set out above and may involve all the operations provided for in Article 4.2 of the GDPR, e.g. collection, storage, processing, cancellation, updating, etc..
3) GROUNDS FOR THE PROCESSING
The processing of your personal data is required by law (EU Directive 2010/84, EU Directive 2012/26 and relevant national implementing legislation).
4) RECIPIENTS OF THE DATA
The Data controller is Chiesi Farmaceutici S.p.A., with registered office in via Palermo 26/A, Parma (Italy).
The Data Controller has appointed a DPO who can be contacted at the following address dpoit@chiesi.com.
5) DATA RETENTION
The personal data relating to adverse reactions reports will be retained as long as the product is authorized and for ten years starting from the expiration or the withdrawal of the marketing authorization of the product in the last country of marketing, except for any defensive needs of the marketing authorization holder. At the end of this period, the data will be deleted or rendered anonymous so as not to allow, even indirectly or by linking other databases, the identification of the data subjects.
6) DATA SUBJECT RIGHTS
The personal data relating to adverse reactions reports will be retained as long as the product is authorized and for ten years starting from the expiration or the withdrawal of the marketing authorization of the product in the last country of marketing, except for any defensive needs of the marketing authorization holder. At the end of this period, the data will be deleted or rendered anonymous so as not to allow, even indirectly or by linking other databases, the identification of the data subjects.
7) DATA SUBJECT RIGHTS
During any stage of personal data processing, you will be entitled to enforce, where applicable, the following rights:
- right to access means the right to obtain from the Data Controller whether your personal data is being processed and, where applicable, have access to it;
- right to rectification and right to erasure means the right to obtain the rectification of inaccurate and/or incomplete personal data, as well as the erasure of personal data when the request is legitimate;
- right to restriction of processing means the right to request suspension of the processing when the request is legitimate;
- right to data portability means the right to obtain personal data in a structured format, ordinary used and readable, as well as the right to transfer personal data to other controllers;
- right to object means the right to object to the processing of personal data when the request is legitimate, including when the personal data is processed for marketing or profiling, if applicable;
- right to lodge a complaint with a supervisory authority in case of unlawful processing of personal data.
- You can exercise the abovementioned rights without formalities by writing to the Chiesi Farmaceutici S.p.A. to the attention of the Data Protection Officer or to the email address dpoit@chiesi.com.
- Your request will be processed without undue delay and in any case within 30 days of receipt of the request, except for more complex cases or due to a large amount of requests received, where said period may be extended by two further months.