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To report an adverse drug reaction

Italfarmaco S.p.A., Data Controller of the personal data processing, pursuant to art. 13 of the Regulation (EU) 2016/679 (hereinafter, the “GDPR”) and the Italian law of harmonization is obliged to inform you, as data subject, with regard to the processing of your personal data collected via spontaneous reporting within the pharmacovigilance system.

1. Purposes of the processing of Data

The personal data will be collected and processed exclusively for the purpose of pharmacovigilance, i.e. to fulfill the Italfarmaco S.p.A.’s obligations imposed by the Italian and European laws on the safety of drugs. These laws requires to Italfarmaco S.p.A. to report to the Health Authorities any possible adverse reactions arising from use or exposure to a drug of Italfarmaco S.p.A. and to answer any requests by the Competent Authorities; the reactions are reported - usually - only indicating the initials and year of birth of the subject, and, with your specific consent, to contact you if necessary, and to reply to any further requests.

2. Consent to processing the Data

The provision of Data to Italfarmaco S.p.A. is optional. For the purposes of paragraph 1, the processing of your data concerning health is subject to your written consent. By giving your consent, Italfarmaco S.p.A is entitled to transmit to the Health Authority your data with respect to the purposes referred to in paragraph 1. In case of the refusal to provide the consent, Italfarmaco S.p.A. will not be able to process your personal data for the above purposes.

3. Data Processing

The Data are processed by Italfarmaco S.p.A. with the support of paper, computerized or telematics means designed to store, manage and transmit the data and in any case by means of instruments suitable for guaranteeing the security and confidentiality of the Data processed, in compliance with the GDPR provisions and of the Italian law of harmonization. Personal data processed for the purposes referred to in paragraph 1 will be stored in Italy in the pharmacovigilance safety database of Italfarmaco S.p.A.

4. Communication of the Data

The processing of your personal data is carried out by internal staff of Italfarmaco S.p.A. and subject to its authority as Data Controller. In addition the data collected and processed can be communicated, for the purposes mentioned above, to other subjects in quality of Processor or Data Controller, namely:

  • the Health Authorities responsible for pharmacovigilance;
  • companies carrying out IT systems’ maintenance services for Italfarmaco S.p.A.;
  • the licensees or licensors of the medicinal product being reported in Italy and abroad, including outside the EU (pursuant to the agreement approved by the local Supervisory Authorities or the Standard Contractual Clauses of the EU Commission executed by the parties).

Italfarmaco S.p.A. do not circulate your personal data.

Personal data collected will be retained as long as the product is authorised and for at least 10 years after the marketing authorisation has ceased to exist and in accordance with current regulations.

5. Rights of the Data Subject pursuant to Articles 15-22 of the Regulation (EU) 2016/679

In relation to the processing of Data, you are entitled to exercise the rights provided for in Articles 15 to 22 of the 2016/679 European Regulation, (reproduced in abbreviated form in Annex A to this statement). Any request may be sent to the Data Controller:
Italfarmaco S.p.A.
Via dei Lavoratori, 54
20092, Cinisello Balsamo (MI)

6. Data Controller is

Italfarmaco S.p.A.
Via dei Lavoratori, 54
20092, Cinisello Balsamo (MI)

7. Data Processor is

Dr. Margherita D’Antuono
Qualified Person for Pharmacovigilance
Italfarmaco S.p.A.
Via dei Lavoratori, 54
20092, Cinisello Balsamo (MI)

8. DPO

Any request on the processing of the personal data may be sent to the Data Protection Officer appointed by Italfarmaco S.p.A. at the following address: infoprivacy.italy@italfarmaco.com or Italfarmaco S.p.A., Via dei Lavoratori, 54- 20092, Cinisello Balsamo (MI).

Regulation (EU) 2016/679 of the European Parliament and of the Council
- Articles 15 to 22 -
According to articles 15 to 22 of the GDPR, the Data Subject has the right to access to a copy of the information comprised in their personal data, object to processing that is likely to cause or is causing damage or distress, object to decisions being taken by automated means, obtain the limitation of the process(in certain circumstances), have (in certain circumstances) his personal data rectified, integrated, blocked, erased or destroyed, obtain the portability of his personal data and the right to propose a claim to the Privacy Authority.
Having read the information notice, I give consent for Italfarmaco S.p.A. to process my personal data, my child’s personal data, legal incompetent’s data for the purpose listed in paragraph 1 of the above mentioned information notice and within its limits.

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